VIEWS: 12 PAGES: 42 POSTED ON: 10/25/2010
FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products Problems Associated with Direct-to-Consumer Advertising (DTCA) of Restricted, Implantable Medical Devices: Should the Current Regulatory Approach be Changed? Bruce Patsner FDLI V OLUME 64 N UMBER 1 2009 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 1 Problems Associated with Direct-to-Consumer Advertising (DTCA) of Restricted, Implantable Medical Devices: Should the Current Regulatory Approach be Changed? BRUCE PATSNER, M.D., J.D.* I. DTCA OF RESTRICTED MEDICAL DEVICES IS AN EMERGING ISSUE Advertising and promotion of Food and Drug Administration (FDA)-approved medical products has been one of the most controversial and bitterly litigated areas in food and drug law in the U.S. for more than a decade.1 Hundreds of newspaper articles and dozens of law review articles have been written on the subject of the risks and benefits of direct to consumer advertising (DTCA) of medical products,2 but until very recently virtually all of this literature and commentary has focused exclusively on prescription and over-the-counter drugs.3 Even when FDA has sponsored public hearings to address the issue of DTCA of all medical products, as it did in 2005,4 review of the content of the speakers’ presentations reveals that almost all of the subject matter, nearly all of the data, and the majority of com- ments concerned DTCA of drugs.5 Not a single law review article has ever been devoted exclusively to the subject of advertising and promotion of medical devices to consumers. A critical analysis of the topic of DTCA of medical devices is important, and its relative neglect in the legal literature unfortunate, for several reasons. First, the medical device industry is growing in size6 and is already enormous, though not so large as the pharmaceutical industry. Second, the medical device industry directly impacts the lives of millions of Americans every day and is the source of * Dr. Patsner is Research Professor, Health Law & Policy Group, University of Houston Law Center, Houston, TX. 1 Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. (1999)). The Washington Legal Foundation (WLF) is still pursuing FDA in federal courts. As recently as 2006, in a follow-up to the 1999 litigation, WLF submitted a Citizen Petition to FDA requesting that the agency review all of its policies regarding prescription drug advertising to ensure that they “comply” with the First Amendment (FDA Docket No. 2006P-0319, (Aug. 7, 2006)). 2 For example, see Hall, Timothy S., The Promise and Peril of Direct-to-Consumer Prescription Drug Promotion on the Internet, 7 DEPAUL J. HEALTH CARE L. 1 (2003). 3 At the time of this writing even the most prominent law journal in food and drug law—THE FOOD AND DRUG LAW JOURNAL—has never had an article devoted specifically to the topic of adver- tising and promotion of medical devices, whether restricted medical devices or not. The most recent (2008) edition of the nationally recognized authoritative casebook on food and drug law (FOOD AND DRUG LAW by Hutt, Merrill and Grossman, Foundation Press 2008) devotes almost thirty pages to an exhaustive discussion of the legal and regulatory issues surrounding the advertising and promotion of prescription drugs, yet no more than a paragraph or two to the same topic for restricted medical devices. 4 Public Hearing on Direct-to-Consumer Promotion of Medical Products, Wash., DC, (Nov. 1-2, 2005). Only one of the 32 speakers at this conference directed all of her remarks to the issue of DTCA of restricted medical devices. 5 Id. 6 The number of manufacturers of medical devices in the United States has effectively doubled every 10-15 years since WWII. See Hutt, supra note 4, Chapter on Medical Devices. 1 2 Food and Drug Law Journal Vol. 64 a significant amount of product-related patient death and serious injury.7 Third, the statutory framework governing regulation of advertising and promotion of medical products is grounded in the 1938 Federal Food, Drug, and Cosmetic Act (FDCA)8 and takes a “one size fits all” approach even though drugs and devices differ enormously. Fourth, the preponderance of FDA attention and enforce- ment action has been devoted to drugs despite the fact that the volume of direct to consumer advertising to both physicians and consumers has been increasing steadily for more than half a decade.9 Fifth, device manufacturers have a generally unrecognized but unique relationship with the different players in the medical profession (surgeons, academic medical centers) compared to pharmaceutical manufacturers. This allows device manufacturers to have some of their advertising for their most important products done through the medical profession itself as a surrogate.10 As a result, medical device manufacturers can circumvent direct FDA oversight of some of their promotional practices in a way that pharmaceutical manufacturers cannot.11 There is also more involvement directly in new technol- ogy development, and direct financial incentive for use by the medical profession for restricted medical devices than for pharmaceuticals. These points will be elaborated on in great detail later in this article. Sixth, be- cause the medical device industry does promote its products directly to the medical profession as well as to consumers just as the pharmaceutical industry does, and has begun to advertise its high-end, restricted, implantable medical devices more aggressively to consumers,12 the subject of DTC advertising of such medical devices merits separate attention. There is already good evidence that consumers both lack the level of medical sophistication to understand these advertisements, and that the advertisements themselves do not fairly balance benefit and risk information. Lastly, the lack of legal analysis of regulatory issues surrounding DTCA and promotion 7 Medical Devices: Problems on the Rise, CONSUMER REPORTS, (Dec. 2007). “Reports of deaths linked to medical devices are at an all-time high, with 2,712 fatality reports in 2006, more than double the number in 1997.” FDA had issued its own report for fiscal year 2006, noting that it had seen a 25 percent increase in adverse events linked to medical devices over Fiscal Year 2005, including 2,830 deaths, 116,086 injuries and 96,495 medical device malfunctions. 8 FDCA, 21 U.S.C. §§ 301 et seq (1938). 9 Pololsky, Scott H. & Greene, Jeremy A., A Historical Perspective of Pharmaceutical Promotion and Physician Education, 300 JAMA 831 (2008). “… by 2006, the world-wide sales of the pharmaceu- tical industry had increased to more than $600 billion, and estimates of the amount of money spent promoting new drugs to U.S. physicians range from $27.7 billion to $57.5 billion.” See also Gagnon, MA & Lexchin, J, The cost of pushing pills: a new estimate of pharmaceutical promotion expenditures in the United States, 5 PLOS MED. (2008). 10 Examples of this will be provided in Section VI of this article. 11 For example, in Perez v. Wyeth Laboratories 734 A.2d 1245 (1999) the learned intermediary doctrine did not apply nor provide protection for pharmaceutical manufacturers when they advertised their prescription drugs directly to consumers. Deceptive direct-to-consumer (DTC) advertising could not, at least in the state of New Jersey, hide behind healthcare providers because the DTC advertis- ing were no longer in a position to reduce the risk of harm from the medical products once they were “bypassed” by DTC advertising. One important aspect of the case is that the medical profession is not really involved in the marketing/promotion loop of DTC advertising for drugs. As will be shown, this is not necessarily the case for some types of medical devices, where the medical profession is involved, either directly or indirectly, with promotion of the products to consumers. 12 Testimony of Ami Gadhia, Consumer’s Union, Concerning the DTC Advertisements for Im- plantable Medical Devices, at Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008)., quoting a WALL STREET JOURNAL article published (Apr. 10, 2007) entitled New Medi- cal-Device Ads; Old Concerns, Can a Knee Implant Be Sold This Way, and Should It Be? which described the growth of DTCA for medical devices and pointed out that the warnings of side effects are generally non-existent or minimal. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 3 of medical devices also places federal and state courts at a relative disadvantage if and when they are faced with adjudicating enforcement actions against medical device manufacturers over this issue. A. General Remarks on DTCA of Medical Products Some general comments on advertising and promotion of FDA-approved medical products are in order. Even though the majority of money (85 percent or more) spent by manufacturers on the advertising of their products is spent on promoting them directly to physicians and the medical community,13 most of the controversy, legal writing, enforcement action and litigation has focused on promo- tion to consumers instead. This should come as no surprise given the predominant marketing-oriented focus of American business, the protection commercial speech enjoys under the First Amendment, and the fact that, aside from New Zealand,14 DTCA is banned in every other Western industrialized nation except the United States.15 One reason for this latter fact is differing government health policies and priorities.16 The healthcare systems of most other countries (e.g., Canada,17 Great Britain) are geared to limiting consumer access and demand for progressively more expensive medical services which often have questionable, marginal or modest incremental health benefits. The United States government does virtually nothing to limit demand for medical services it subsidizes through entitlement programs,18 and our current payment system to physicians rewards prescribing more drugs and using more implantable surgical and cardiac medical devices. Examples of these include prescribing expensive new cancer chemotherapies to treat patients with refractory end-stage cancers and high-technology medical devices such as 64-slice 13 Berndt, Ernst R., To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs, 352 N. ENGL. J. MED. 325 (2005). 14 New Zealand was supposed to ban direct to consumer advertising of medical products in 2006. The New Zealand government had been seriously considering this for years. 15 Palumbo, Francis B. and Mullins, Daniel, The Development of Direct-to-Consumer Prescription Drug Advertising Regulation, 57 FOOD AND DRUG L.J. 423 (2003). 16 Calfee, John E., American Enterprise Institute, Direct-to-Consumer advertising of prescription medicines in the United States and New Zealand: An analysis of regulatory approaches and consumer responses, FDA Public Hearing on Direct-to-Consumer Promotion of Medical Products, (Nov. 2, 2005). The author points out that unlike the United States, New Zealand has a small economy, predominately government-funded healthcare, regulated drug prices, and advertising self-regulation combined with loose oversight by the Ministry of Health. Despite these differences, the author’s research indicated that although DTC advertisements in the two countries differ, consumer surveys in both nations reveal remarkably consistent results on several essential points such as little benefit and little evidence of direct harm. 17 FDA Webview, No DTC in Canada, Group Says, (Jan. 31, 2006), available at http://www.fdaweb. com/start.php?sa=v&aid=D5101807&cate=&stid=%241%24Zy1.us..%..(last accessed Feb. 1, 2006). This note quotes the White Paper Direct-to-Consumer Advertising of Prescription Drugs in Canada: What are the Public Health Implications, “The Health Council of Canada, a government-appointed group charged with monitoring and reporting on the progress of health care renewal in Canada, says DTC drug advertising in Canada should be curtailed ‘in the interest of patient safety and public health …There is no reliable evidence that DTC improves patient compliance in taking medication or leads to more appropriate early diagnosis of under-treated conditions, or prevents hospitalization and serious disease consequences … exposure to DTC advertisements results in increased requests for prescription medications.’” 18 Rago, Joseph, The Election Choice: Health Care, THE WALL STREET JOURNAL, Opinion, (Oct. 24, 2008), at A19. The Center for Medicare and Medicaid Services (CMS) has on occasions announced that it would not pay for select medical services, but these are rare events. Federal spending on Medicare and Medicaid is exploding, and over the past three decades has more than doubled its share of GDP and will double again in 25 years. 4 Food and Drug Law Journal Vol. 64 cardiac CT scanners and coronary artery stents. Prohibiting DTCA is one of the most important ways in which foreign countries restrict demand for prescription drugs and for expensive medical/surgical services which involve restricted medical devices. It is easier to restrict access to new, expensive therapies if one is successful in limiting demand. The potential consumer educational benefits of advertising of medical prod- ucts aside,19 no one on either side of the DTCA debate disputes the fact that one of the primary reasons for advertising medical products is to increase consumer demand20 and product market share for the manufacturers, and to distinguish a product from competitors.21 Growth of DTCA spending in the U.S. provides some perspective on this statement. After passage of the Food and Drug Ad- ministration Modernization Act of 1997 (FDAMA),22 growth of DTC spending increased from $791 million in 1996 to over $3 billion in 2004.23 Given the fact that physicians in the United States have strong financial incentives to prescribe the most expensive cancer drugs or utilize the latest and invariably most expensive diagnostic and therapeutic medical technologies, the production-marketing-use- demand-production cycle becomes self-reinforcing. DTCA is a vital component of this cycle as well, since some of what some physicians do is a reaction to patient demands. Research has shown both that consumers are susceptible to directed advertising of drugs,24 and that some medical practice is driven by this demand as well.25 Research has also shown that demand for surgical therapies and devices can be driven to some degree by advertising.26 Although there is no universally 19 Gilbody, S., Wilson, P. & Watt, I., Benefits and Harms of direct to consumer advertising: a system- atic review, 14 QUAL. SAF. HEALTH CARE 246 (2005). The Pharmaceutical industry claims one of the main benefits of DTCA is patient education. Although there is the potential for DTCA to be educational, the primary benefit is for the manufacturer in the form of increased market share and profits. 20 Loden, D. John & Schooler, Caroline, Ph.D., How to Make DTC Advertising Work Harder, MEDICAL MARKETING AND MEDIA, (Apr. 1998). A comment by these two DTC advertising executives at FCB Healthworks stated, “The ultimate goal of DTC advertising is to stimulate consumers to ask their doctors about the advertised drug and then, hopefully, get the prescription.” 21 See NY TIMES (July 1, 2008). For example, Myriad Genetics of Salt Lake City initiated a mass direct to consumer advertising campaign for their BRCA genetic testing for predisposition to breast and ovarian cancer which resulted in a doubling of revenue. No more than 5-10 percent of all women in the U.S. could theoretically benefit from such genetic screening, yet the DTC advertising campaign did not attempt to discriminate, and was directed at all women. 22 FDAMA, PUBLIC LAW 105-115. 23 Judith A. Cahill, Executive Director, Academy of Managed Care Pharmacy, Statement before FDA Public Hearing on DTC Advertising, Wash., D.C., (Nov. 2, 2005). It was not stated whether there was a direct cause-effect relationship between the passage of FDAMA and the increase in spending on DTC advertising. 24 The Henry J. Kaiser Foundation, Impact of Direct-to-Consumer Advertising on Prescription Drug Spending, (June 2003) p.7. The DTC advertising strategy works: “DTC advertising produces a significant return for the pharmaceutical industry: every additional $1 the industry spent on DTC advertising in 2000 yielded an additional $4.20 in sales.” 25 Kravitz, Richard I., Epstein, Ronald M., Feldman, Mitchell D., et. al., Influence of Patients’ Requests for Direct-to-Consumer Advertised Antidepressants. A Randomized, Controlled Trial, 293 JAMA 1995 (2005). 26 Jaffee, M.J., HealthpointCapital, Orthopedic and Dental Industry News, Impact of Direct-to-Con- sumer Advertising, (Apr. 6, 2006), available at http://www. Healthpointcapital.com/research/2006/04/06/ impact_of_directtoconsumer_advertising (last accessed October 27, 2008). The article cites research by Orthopedic Surgeon Kevin Bozic of the University of California San Francisco School of Medicine which was presented at the Health Policy Symposium at the 2006 American Academy of Orthopedic Surgery (AAOS) meeting. Dr. Bozic’s findings were that 50 percent of orthopedic surgeons polled said that they found pressure to use a “particular surgical technique approach or specific type of implant” by patient request based on viewing a DTCA. Some of the DTCA was internet-based and some televi- sion broadcast. Sixty percent of the time patients had an opinion about what should be done surgically before they ever spoke to the surgeon. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 5 accepted data which demonstrates that consumers are directly harmed by DTC advertising, there is indirect data. However, because virtually all of the data is based on studies involve promotion of drugs, not devices, the opposite is also true: there is no real evidence of any educational benefit of advertising medical devices directly to consumers, and already some data to suggest that consumers do not really understand the information being conveyed in broadcast promotions for restricted medical devices.27 If that is the case, and advertising to consumers helps drive demand, little good will come of a situation in which “lacking expert knowledge, they [consumers] are not in a position to make prudent purchasing decisions.”28 In all fairness, some commentators have pointed out that DTCA offers an oppor- tunity for manufacturers to educate consumers about diseases; increase consumer awareness about disease symptoms, inform consumers about treatment options, alternative treatment options, and diagnostic procedures; stimulate patient-physi- cian dialogue on vital health issues; and possibly encourage healthier lifestyles.29 Unfortunately, it is difficult to achieve all of these objectives, particularly in the limited time span of broadcast media, when advertising promotes a specific medical product (as opposed to awareness about a particular disease) whether it is a device or a drug. Where there is promotion and advertising of a specific product, it is possible and perhaps even more likely that DTCA will do consumers a disservice. This is because the primary aim of that type of promotion is not educational, but rather is to induce product name recognition and create patient demand for the product.30 This is so even if there is no intent to be misleading about the benefits and or risks of the product; not fully explain risks, particularly if surgery is involved (e.g., it is an implantable device); or be silent about alternative treatment options, particularly if alternatives are a competitor’s device or not using the device at all and treating with medical therapy only. According to the 2002 report by the General Accounting Office (GAO)31 the pharmaceutical industry’s track record on fair and balanced information in DTCA is not encouraging. Importantly, there is absolutely no evidence that the restricted medical device industry’s conduct is any better. The conclusions of the GAO re- port on DTCA were that 1) DTC advertising appeared to increase drug spending and utilization; 2) DTCA was concentrated among a small number of drugs32 and conditions rather than directed at sweeping public health issues; and 3) some manu- facturers repeatedly disseminated misleading ads for the same drugs, disregarded repetitive warnings from FDA, and failed to submit in a timely manner (or at all) newly disseminated advertisements to FDA for review. The limitations of FDA’s 27 Statement by William E. Boden, M.D., Professor of Medicine SUNY at Buffalo School of Medicine, at Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?: Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008).[hereafter Boden statement]. 28 Relman, Arnold, McCain, Obama, and the National Health, THE NY REVIEW OF BOOKS, (Nov. 6, 2008), at 27. 29 Pines, Wayne L., A History and Perspective on direct-to-consumer promotion, 54 FOOD AND DRUG L.J. 489 (1999). 30 See fn 21. 31 UNITED STATES GENERAL ACCOUNTING OFFICE, REPORT TO CONGRESSIONAL REQUESTERS, PRE- SCRIPTION DRUGS. FDA OVERSIGHT OF DIRECT-TO-CONSUMER ADVERTISING HAS LIMITATIONS, (Oct., 2002), available at http://www.gao.gov/new.items/03177.pdf (last accessed Oct. 27, 2008). 32 Id. 6 Food and Drug Law Journal Vol. 64 oversight over DTCA were apparent to the GAO as well.33 Even FDA surveys34 on consumer behavior associated with DTC advertising campaigns for prescription drugs provide further evidence of the legitimacy of these concerns. Within the field of DTCA, the overwhelming financial expenditures, emphasis, controversy, and amount of enforcement action is on the advertising and promo- tion of drugs, not medical devices, to consumers.35 There are likely several reasons for this. First, the pharmaceutical industry is larger, more profitable, and has more products, than that of the medical device industry despite the fact that the growth of the medical device industry in the United States has increased almost exponentially every decade.36 In aggregate and as individuals, more patients take prescription and over-the-counter drugs, and take more kinds of drugs, than use medical devices. Second, for the past eight years there has been dramatically more controversy and Congressional oversight for the Center for Drug Evaluation and Research (CDER) than there has been at either the Center for Biologics Evalu- ation and Research (CBER) or the Center for Devices and Radiological Health (CDRH).37 Third, litigation follows the money and the volume of business. Lastly, the pharmaceutical industry has much more experience with DTC advertising and promoting, and much more litigating over its presumed right to do so, than the medical device industry. These facts notwithstanding, DTCA of medical devices is a new and growing presence. The amount of money spent by medical device makers in 2007 on television and internet advertising was $193 million, up from $116 billion in 2005. By comparison, pharmaceutical manufacturers spent over $4 billion on DTCA in 2005.38 B. A New Type of DTCA for a Restricted, Implanted Medical Device The relative lack of attention to direct to consumer restricted medical device promotion by manufacturers may be changing. Despite the much greater empha- sis on DTCA of drugs, there are some signs that more attention is being paid to 33 Id. 34 Aikin, Kathryn J., Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA, Attitude and Behaviors Associated with Direct-to-Consumer Advertising of Prescription Drugs: Summary of Survey Results, FDA Scientific Rounds, (Mar. 30, 2005), available at http://www.cdernet. cder.fda.gov/dtd/Rounds/Fall04/bg3-30.htm (last accessed Mar. 30, 2005). DDMAC’s survey noted that although DTC advertisements increase awareness of possible treatments, DTC advertisements did not convey information about risks and benefits equally well. In particular, it was clear that physicians believe patients understand benefits much better than risks (no surprise actually if more benefit than risk information is presented). The physicians also believed that DTC advertisements confuse patients about relative risks and benefits of drugs. 35 Weinberg, Matthew R., Direct-to-Consumer Advertising: U.S. and European Perspectives, FDLI UPDATE (Nov./Dec. 2004). “From 1996 to 2001 annual spending of U.S. pharmaceutical companies on DTC advertising for prescription drugs tripled, reaching nearly $2.8 billion.” No such comparable data is available for medical device manufacturers for that period of time. 36 Cooper, Theodore H., Device Legislation, 26 FOOD DRUG COSMETIC L.J. 165 (1971). In 1937 there were 463 medical device manufacturers. By 1947 this number had increased to 980, and then again to over 1,500 by 1967. 37 United States Government Accountability Office, Report to Congressional Requesters, Drug Safety. Improvement Needed in FDA’s Post-market Decisionmaking and Oversight Process, (Mar. 2006). 38 Mitka, Mike, Direct-to-Consumer Advertising of Medical Devices Under Scrutiny, 300 JAMA 1985 (2008). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 7 DTCA of medical devices by prestigious medical journals39 and Congress.40 Both may have the medical device industry and its new, more aggressive DTCA market- ing campaign to thank.41 Recently a threshold of sorts was crossed in the arena of direct to consumer advertising of restricted medical devices when DTCA for medical devices reached a national level, and audience, which previously had traditionally been reserved only for drugs. During a Thanksgiving Day football game between the New York Jets and the Dallas Cowboys on November 22, 2007, U.S. consumers were treated to something they had virtually never experienced before: a nationally advertised DTC advertisement for a drug-eluting coronary artery stent, an implantable, re- stricted, Class III medical device. The advertisement was for Cypher, a drug-eluting coronary artery stent manufactured by the Cordis division of Johnson and Johnson, Inc. of New Brunswick, New Jersey.42 Consumers were also exposed to the need for the interventional cardiology procedure (percutaneous transluminal coronary angioplasty or PTCA) required to insert the stent into the human heart. The targeted audience for this restricted device was the middle-aged male with known coronary artery disease, or multiple risk factors for the same, sitting on a couch watching the football game. The Cypher medical device and procedure for implantation into the heart are so complicated that there was virtually no way that the average reasonable consumer viewing the advertisement could possibly derive any educational benefit from the advertisement. Nor was there any meaningful way for the viewer of the advertisement for this medical device to know that such devices have been surrounded by controversy for years over safety issues (e.g., breakage issues for Boston Scientific’s comparable device),43 efficacy issues (i.e., whether a drug eluting stent works any better than a plain metal stent),44 and fundamental questions about whether the clinical trials FDA uses to approve devices were inferior to those used for new drug approvals.45 The only thing missing was an endorsement by a major medical center or group of physicians for the product.46 What was not missing from this new type of promotion was the fact that the road to the device went right through the physician’s office, either on referral from a primary care physician or by going directly to a cardiologist. The actual degree of direct involvement of the medical profession in the promo- tion of this product was negligible; there was no medical center sponsorship or 39 Boden, William E. & Diamond, George A., DTCA for PTCA—Crossing the Line in Consumer Health Education? 358 N. ENGL. J. MED. 2197 (2007). 40 Meier, Barry, Consumer Ads for Medical Devices Subject of Senate Panel, THE NY TIMES, (Sept. 17, 2008, available at http://www.nytimes.com/2008/09/17/business/17device.html?_r=2&oreg=slogin& ref=today (last accessed Sept. 17, 2008). 41 Boden statement, supra note 28. 42 The coronary artery stent market is one of the largest and most lucrative medical device markets in the United States, for both plain metal and drug-coated stents. The coated devices are newer and more commonly used than bare-metal stents, and at $2000 apiece, cost more than twice as much as bare metal devices. The global coronary artery coated stent market was valued at about $4 billion a year in 2007. See Kamp, Jon, Cleveland Clinic Foregoes Boston Scientific Stent, THE WALL STREET JOURNAL, (Aug. 13, 2008) at B1, available at http://online.wsj.articles/SB121859886184436023.html?mod=2_1566_leftbox (last accessed Oct. 18, 2008). 43 Winstein, Keith J., Boston Scientific Stent Study Flawed, WALL STREET JOURNAL, (Aug. 14, 2008) at B1. 44 Mauri, Laura, Silbaugh, Treacy S., Garg, Pallav, et. al., Drug-Eluting or Bare-Metal Stents for Acute Myocardial Infarction, 359 N. ENGL. J. MED. 1330 (2008). 45 Winstein, supra note 44. 46 This would actually come later, when the Cleveland Clinic announced its preference for the stent of one manufacturer over another’s in an advertisement of sorts to consumers. 8 Food and Drug Law Journal Vol. 64 endorsement by celebrity scientists such as Robert Jarvik.47 There was certainly no shortage of negative commentary48 from many prominent cardiologists in academic medicine about the shortcomings of the information, and the complexity of the medical problem glossed over when presented to a carefully targeted audience. Real concern was also expressed about what appeared to be the ominous development of a likely new front in the wars over commercial speech protection of the rights of companies to advertise and promote their prescription medical products to naïve and vulnerable patient populations, a phenomenon noted even by knowledgeable food and drug law attorneys used to representing industry.49 This restricted medical device advertising was a new development, and demon- strated a new, more aggressive trajectory for DTCA for certain medical devices. There was also a new public and medical profession awareness of the old issue of direct to consumer advertising for a new industry: medical device manufacturers. More importantly, new questions arose about the potential role the medical profes- sion itself played in this process. This newly found scrutiny of medical device DTCA, particularly in the medical literature, continues to raise questions, and continues to make physicians and legislatures uneasy at the time of this writing.50 Our attention must now turn to these issues. We will first review some basic FDA regulation of medical devices, then examine the regulation of advertising and promotion of medical devices, particularly compared to that for drugs. Lastly we will examine the potentially unique role the learned intermediary or its institutions can play in restricted, implantable medical device promotion. II. RESTRICTED MEDICAL DEVICES It is assumed that the reader is familiar with FDA’s risk-based classification of medical devices and the pathways to commercialization.51 A prescription medical device is one which has been approved for marketing via the PMA process or 510(k) clearance mechanism and which is deemed safe for use only when administered under the supervision of a licensed practitioner (physician). Some Class II, and virtually all Class III medical devices, are prescription medical devices. In the past, FDA declared that all prescription medical devices would be deemed restricted medical devices, but this position was rejected by the courts.52 One way to view restricted medical devices is as a subset of prescription medical devices since a prescription device may or may not be restricted device.53 It is better to think of restricted devices as analogous to prescription drugs though the statute 47 The cholesterol drug advertisements which featured “Dr.” Robert Jarvik caused considerable controversy, both because of the ostensible imprimatur of endorsement by a “heart doctor” and the fact that Dr. Jarvik was not a physician, a fact impossible to ascertain from viewing the advertisement. 48 Medical Design Technology, Device Firms Go Direct to Consumers Amid Physician Skepticism, available at http://www.mdtmag.com/scripts/ShowPR.asp?PUBCODE=046&ACCT=0006418&ISSUE (last accessed Oct. 6, 2008). A typical comment was that of William E. Boden, M.D., an academic cardiologist and Clinical Chief, Cardiovascular Medicine at SUNY at Buffalo School of Medicine, who pointed out that the Cypher ad was particularly problematic because it omitted important adverse event information included in the company’s patient information brochures. 49 Reeves, Kelly N., Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or Manipulating a Vulnerable Population? 53 FOOD & DRUG L. J. 661 (1998). 50 Mitka, supra note 38. 51 For additional information the reader is directed to the CDRH website, available at www.cdrh. fda.gov. 52 Becton Dickinson v. FDA, 589 F.2d 1175 (2nd Cir. (1978)). 53 FDCA § 502(f) and 502(e), 21 U.S.C. 352(f) and 360j(e). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 9 is crafted in such a way as to give FDA, through the Secretary of the Department of Health and Human Services (HHS), more flexibility in restricting device use or distribution.54 Medical devices may become restricted in one of three ways.55 A restricted medical device is a medical device which can be sold, distributed, used or ordered 1) only upon the written or oral authorization of a practitioner licensed by law to administer or use such a device (i.e., based on a valid prescription written by a physician); or 2) upon other conditions which might be set by the Secretary of HHS in a regulation if, because of its potentiality for harmful effect or the collateral measures necessary for its use that there cannot otherwise be reasonable assurance of its safety and ef- fectiveness.56 This can occur either as a condition of approval of a Class III device that its sale and distribution be restricted; or as part of a performance standard requiring that the sale and distribution of the device be restricted.57 A medical device can also become restricted by separate regulation. Most, but not all, restricted medical devices are Class III devices, because Class III devices are either prescription devices or their distribution is restricted as a condition of premarket approval (PMA). There are exceptions though. For example, diagnostic kits for genetic testing which employ analyte-specific reagents (ASRs) in house (so called “home brew” diagnostic tests) are regulated by FDA as restricted as Class II, not Class III, medical devices. Another large group of re- stricted medical devices which are Class II devices are those used in the operating room by surgeons. Advanced laparoscopic equipment, innovative intra-operative lasers and similar equipment are all types of medical devices which would not normally be used by anyone other than a licensed physician yet are classified as Class II medical devices by FDA. Lastly, although restricted medical devices may be generally thought of as a subset of prescription medical devices, some restricted devices are over or behind-the-counter. For example, FDA has issued a restricted device rule for over-the-counter test sample collection systems for drugs tested for in substance abuse programs. Both prescription and restricted medical devices are subject to FDCA medical device general labeling requirements. Restricted medical devices may also be subject to additional labeling and misbranding requirements, as noted, as a condition of their use. The regulatory requirements for a prescription medical device which help prevent the device from being misbranded include 1) the device is in the possession of the practitioner or firm licensed by law to use or order the use of the device; 2) the device is sold only to or on the prescription or other order of such practitioner for use in the course of professional practice; 3) the label of the device bears the legend “Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician (this does not apply to surgical instruments); 4) if the labeling is included in the device package it contains “adequate information for use,” defined to mean indications, effects, routes of administration, relevant hazards, contraindications, side effects and precautions under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended; and 54 American Pharmaceutical Ass’n v. Weinberger, 377 F.Supp. 824 (D.DC (1974)). 55 Statement by Daniel Schultz, MD, Director, CDRH at Marketing or Medicine: Are Direct-to- Consumer Medical Device Ads Playing Doctor?: Hearing before the Senate Special Committee on Aging, 110th Congress, (Sept. 30, 2008) available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008) [hereafter Schultz statement]. 56 FDCA § 520(e). 57 Id. and 514(a)(2)(B)(v) of FDCA. 10 Food and Drug Law Journal Vol. 64 5) if the labeling is not packaged with the device (e.g., a promotional brochure), it must contain “adequate information for use” if it furnishes any information about the intended use or indications for use of the device Even though FDA regulates the labeling of all medical devices its statutory au- thority does not extend to regulation of advertising of all medical devices. In this sense the regulatory framework for medical devices is similar to that for drugs: FDA only regulates the advertising and promotion of prescription drugs even though it regulates the labeling for all drugs. Advertising of all other drugs and devices is the jurisdiction of the Federal Trade Commission (FTC).58 Thus, the classification of a medical device as a restricted device is of critical importance because FDA regulates the advertising and promotion only of restricted medical devices. III. GENERAL PRINCIPLES OF FDA REGULATIONS AND GUIDANCE GOVERNING ADVERTISING AND PROMOTION OF MEDICAL PRODUCTS TO CONSUMERS A. The Critical Questions Regarding FDA Regulation of DTCA Is advertising and promotion of restricted medical devices regulated by FDA the same way that it is for drugs? If it is, should it be? If there are no important differences between restricted medical device and prescription drug advertising, then their DTC advertising should be regulated the same way, even if they are not. To answer these important questions, several things must be examined. First, the basic FDA statutory requirements governing advertisement of prescription drugs and restricted medical devices should be compared to see if the criteria for determining that an advertisement is false, deceptive or misleading are the same for prescription drugs and restricted devices. Second, the FDA Guidance Documents for advertisement and promotion of prescription drugs should be compared to those for restricted medical devices, both for printed advertisements as well as broadcast advertising, to determine if the general regulatory recom- mendations are both similar and adequate to ensure consumer safety for these two classes of products. Lastly, the manner and content of prescription drug and restricted medical device advertisements should be examined to see if there are significant enough differences to suggest that the way they are regulated should not be the same. The latter question is particularly important because of the role the medical profession itself plays as a surrogate advertiser for medical device manufacturers. A discussion of FDA regulation of advertising and promotion of restricted medical devices and prescription drugs first requires certain terms be defined. For purposes of FDA regulation, label means “a display of written, printed or graphic mater upon the immediate container,”59 Labeling means “labels and all other written, printed or graphic matter 1) upon any article or any of its containers or wrappers, or 2) accompanying such article.”60 Labeling is viewed expansively by FDA and may encompass virtually any written or oral communication with customers, whether the customer is a physician who may use the device or a con- 58 Memorandum of understanding (MOU) with FTC Concerning Exchange of Information, FDA-225-71-8003 (Oct. 1, 1980). 59 FDCA § 201(k), 21 U.S.C. § 321(k). 60 FDCA § 201(m), 21 U.S.C. § 321(m). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 11 sumer to whom the device is being advertised. The label, which is packaged with the device, is generally considered separate from labeling materials which promote the device either to physicians or consumers; the latter are usually referred to as promotional labeling or promotional material in FDA enforcement letters sent to the manufacturer. The same rules, however, apply to promotional labeling as well as to all other labeling. One of the critical items contained in the label for a medical product are the claims being made about the product. A claim is a representation about the expected performance, efficacy, safety or clinical utility of a medical device.61 Because they appear in the label and must be consistent with the approved intended use, FDA regulates claims appearing in the labeling of all medical devices and drugs. Advertising, as opposed to labeling, is not a term defined in the FDCA.62 FDA has defined advertising in the Federal Register63 for drugs only; there is no specific advertising definition for medical devices which is the counterpart to that for drugs. By consensus though, the drug advertising definition is what FDA uses to determine whether a promotional material for a device is advertising. As with labeling, advertising is also viewed or defined expansively by FDA. Advertising can include information published in consumer or medical magazines, newspapers, medical journals or other periodicals or written materials, or broadcast through media such as radio, television, telephone or the internet. Both restricted and non- restricted medical devices are advertised in printed and broadcast media. FDA possesses only limited authority to regulate only the advertising and promotion of “restricted devices” which are those expressly designated as such in the relevant PMA approval order, or a regulation because of the “potentiality for harmful effect or the collateral measures necessary for ‘safe and effective’ use.”64 The general rules and First Amendment case law65 which govern DTCA are the same for prescription drugs and restricted medical devices. Manufacturers cannot advertise off-label uses of either prescription drugs or restricted devices to consumers, although in general the extent of FDA monitoring of this activ- ity is unknown and data on the prevalence of promotion of off-label uses of restricted medical devices to consumers are sparse. Manufacturers can advertise and promote uses/indications for the drug or device which appear in the approved drug or device label.66 Sections 502(q) and 502(r) of the FDCA provide FDA with the regulatory authority to regulate restricted medical device advertising and promotion. 61 Shapiro, Jeffrey K., Labeling and Advertising of Medical Devices, in PROMOTION OF BIOMEDICAL PRODUCTS, Colonna, Thomas E. & Shapiro, Jeffery K. eds. (Food and Drug Law Institute, (2006)).[Here- after Colonna]. 62 Id. 63 21 C.F.R. § 202.1(l)(1). 64 FDCA § 502(q), 502(r), 515(d)(1)(B)(ii), 21 U.S.C. § 352(q), 352(r ), 360j(e), 360j(e), 360e(d)(1)(B)(ii). There are some devices that are designated as restricted devices just on the basis of a regulation: these are hearing aids and ASRs. See 62 Fed. Reg. 62,259 (Nov. 21, 1997) and 42 Fed. Reg. 9296 (Feb. 15, 1977). 65 PETER BARTON HUTT, RICHARD A. MERRILL & LEWIS GROSSMAN, FOOD AND DRUG LAW. CASES AND MATERIALS (3rd ed. 2007), p. 535-560. 66 FDA, 2008 Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, available at http://www.www.fda.gov/oc/op/goodre- print.html (last accessed May 16, 2008). Federal Register, (Feb. 20, 2008), Vol. 73 No. 34. “the [FDCA] and FDA’s implementing regulations generally prohibit manufacturers of new drugs or medical devices from distributing products in interstate commerce for any intended use that FDA has not approved as safe and effective or cleared through a substantial equivalence determination.” 12 Food and Drug Law Journal Vol. 64 B. Statutory Requirements for DTCA of Restricted Medical Devices The main content for any advertisement for a prescription drug or restricted de- vice are the claims made to physicians and/or consumers about the product. There are several fundamental principles which govern DTCA regulation of restricted medical devices. Sections 502(q) and 502(r) of the FDCA67 impose specific require- ments on the advertising of restricted medical devices. Section 502(q)68 provides that a restricted medical device is misbranded if its advertising or promotion is false or misleading in any particular, i.e., if any of the claims about the product are false or misleading in any particular. Section 201(n)69 of the Act provides that many factors may be taken into account in determining whether an advertisement is misleading. This includes not only representations about device use in the spe- cific advertisement, but also whether the advertisement fails to reveal important, material facts about the device or the potential adverse consequences of its use. As will be discussed, there are differences between prescription drugs and restricted medical devices in what information constitutes an important material fact and what potential adverse consequences of use are. Section 502(r) of the FDCA70 provides that a restricted medical device is mis- branded if any advertising relating to the device does not contain a brief state- ment of the device’s intended use/intended patient population, as well as relevant warnings, side effects, contraindications, and precautions about the device. This statute71 also notes that the brief summary must have fair balance. The result of these statutes is that all restricted medical device advertising must affirmatively include:72 1) a true statement of the medical device’s name or trade name; and 2) a brief statement of the intended uses of the device and relevant warnings, pre- cautions, side effects and contradictions73 which present a “fair balance” of risk and benefit information. The risk information must be provided in “consumer friendly” language; and there must be “adequate provision” for dissemination of more information provided in the package label if the actual label is not provided. These are the minimum requirements. What the “brief statement” must contain in an advertisement in order to avoid being considered “false or misleading in any particular” also depends on several other factors: 1) the particular promotional medium; 2) whether it is a device-specific claim, (i.e., whether it is a product claim or advertisement); and 3) whether it is a help-seeking or disease awareness ad. In 2004 FDA issued two guidance documents relating to advertising and promotion of restricted medical devices which will be discussed in the next section. FDA may impose additional advertising restrictions and requirements as part of the PMA approval process. In general, the brief summary must include “each specific side effect and contraindication” (i.e., all risk concepts). Manufacturers have historically complied with this by reprinting risk-related sections of product labeling, though verbatim reprinting is not required.74 67 FDCA § 502(q), 502(r). 68 FDCA § 502(q), 21 U.S.C. § 352(q), 69 FDCA § 201(n). 70 FDCA § 502(r), 21 U.S.C. § 352(r). 71 21 C.F.R. 202.1(e)1. 72 FDCA § 502(e), 21 U.S.C. § 352(e). 73 FDCA § 502(q)-®, 21 U.S.C. § 352(q)-(r) 74 Melissa Moncavage, Leader, DTC Review Group, DDMAC, FDA. CDER Scientific Rounds, (Mar. 30, 2005), Current DTC Promotion Activities and Environment, available at http://www.cdernet. cder.fda.gov/dtd/Rounds/Fall04/bg3-30.htm (last accessed Mar. 30, 2005). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 13 In evaluating whether claims made about a medical device by its manufacturer meet the statutory requirement of being truthful and non-misleading, FDA typi- cally will look at all of the promotional materials in a product-specific advertising campaign to obtain a general sense of whether the advertisement is false or mis- leading. Much of this is a subjective sense of whether the material fairly balances safety risks and touted benefits or if potential adverse effects are minimized. In- terestingly, it is permissible75 for a medical device advertisement to consumers to reference the fact that a medical device was approved by FDA via a PMA, but not via a 510(k) clearance. Advertising to consumers that a device reached the market via 510(k) clearance is considered false and misleading,76 even though consumers are: 1) likely completely oblivious to the difference in marketing mechanisms; and 2) unaware of the fact that only a PMA approval generally rests on an agency de- termination that they have reasonable assurance that a device is safe and effective rather than a conclusion that the device is merely substantially equivalent to an already marketed device. Another decisive factor for determining whether an advertising claim is truth- ful and non-misleading is that the claim be must be adequately substantiated77 by real-world data which existed at the time the advertising claim was made. Again, the type of marketing application for the device is relevant for advertising. For medical devices which were approved via a PMA data normally would not be a problem since submission of substantial, independent safety and efficacy data is a requirement of FDA’s marketing approval application. For medical devices which reached the market via 510(k) clearance though, the amount of safety and effi- cacy data sent to FDA may vary enormously from little to none to a clinical trial. It is possible, and even likely, that the safety and efficacy data for the device are actually those of the predicate device, which are presumably similar to the device being advertised. If there are only bench (lab) or animal data for the device being advertised, this information must be conveyed to consumers via a disclaimer even though the limited data on the usefulness of disclaimers suggests they are ignored by consumers.78 Drug superiority claims require data to support this, and FDA generally has taken the same approach for comparative device claims even though there is no guidance document specifically on this subject. There are other major significant statutory requirement differences. Although it is true that there is no statutory requirement that prescription drug advertisements be submitted to FDA for review prior to their being printed or broadcast, there is an important exception for new drugs reaching the market through accelerated approval. These are the drugs being used to treat life-threatening illnesses with few or any therapeutic options, the very situation in which some restricted implant- able medical devices are used.79 By contrast, there is no statutory requirement that advertisements for restricted medical devices be submitted to FDA prior to dis- semination, and no situation or exception to this either as there is for drugs. CDRH acknowledges80 that, as a rule, it never reviews restricted medical device advertise- ments prior to their appearance in print or television, except on that rare (if ever) occasion where a manufacturer elects to send it to CDRH ahead of time. 75 21 C.F.R. § 808.97. 76 Id. 77 Id. 78 Id. 79 An important difference is that Subpart H approvals are based on surrogate endpoints, whereas it is not certain that PMA approvals require additional clinical study validation. 80 Schultz statement, supra note 55. 14 Food and Drug Law Journal Vol. 64 Another major statutory difference between DTC drug and restricted medical device promotion occurs at the time of actual dissemination in print or broadcast. Prescription drug manufacturers are required, by submission of a form 2253, to submit copies of advertisements to FDA at the time of media distribution, whereas medical device manufacturers are not required to submit any copies of printed or broadcast ads to FDA at the time they are being shown to consumers. There are also more subtle differences in the regulatory requirements. FDA’s device regulations contain more general requirements for advertising and promo- tion than those for prescription drug advertising, which are both more specific and broken down into specific and differing requirements for printed ads and broadcast ads. The general requirements for restricted medical device promotion arise from §§ 502(q) and (r) of the FDCA and merely note first, that advertisements and promotions cannot be false or misleading in any particular, and second, that ad- vertisements and promotions must contain the brief statement which describes the restricted medical devices intended use, side effects, contraindications, precautions and relevant warnings. These general requirements for restricted medical device advertising have been supplemented with the 2004 guidance documents only for broadcast advertisements; this will be discussed shortly. For prescription drugs the general requirement for advertisements mandate that they cannot be false or mis- leading in any particular or omit material facts, and they must present a fair balance between safety risks and potential benefits. For printed ads there is the brief sum- mary requirement which must contain the most serious as well as the most common risks which appear in the label. For broadcast ads manufacturers have the option of providing either the brief summary, the same as for a printed advertisement, or the option of making adequate provision of the information in the approved label by providing an 800 number, manufacturer or product website, a statement telling the consumer to call their physician to get more information, etc. Lastly, the recently enacted FDA Amendments Act of 2007 (FDAAA) contained a section81 which included greater authorization for FDA to require pre-review of DTC drug advertisements to ensure that consumers are adequately informed of safety risks. C. FDA Guidance Documents for DTCA Differ for Drugs and Devices In addition to the statutory requirements governing advertising and promotion of medical products, FDA has also published a series of Draft Guidances for In- dustry designed to improve information provided both to consumers and healthcare providers in advertisements about medical products and related health conditions. Although guidance documents are not legally binding, they do represent current FDA thinking on topics of importance and are designed to help sponsors comply with FDA regulatory requirements. There is no single guidance document on advertising and promotion that com- prehensively addresses both prescription drugs and restricted medical devices. There are separate guidance documents for printed and broadcast advertisements, two Draft Guidances directed at products regulated by both CDER and CBER, and only one draft guidance which is device-specific and directed only at products regulated by CDRH. 81 FDAAA, PUBLIC LAW 110-85, § 503B. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 15 The first Draft Guidance on “Consumer-Directed Broadcast Advertisements” as well as its related publication on “Questions and Answers” was published in its final version in August, 1999;82 this document applied both to drugs, biologics, and animal drugs but not to restricted medical devices. Given that devices have not received much in the way of separate regulatory and media attention until recently, it should not be surprising that the only Draft Guid- ance for Industry which deals specifically with restricted medical devices was not released until four years ago. On February 4, 2004 FDA announced83 in the Federal Register84 the availability of three Draft Guidances for industry dealing with three issues arising out of discussions and presentations at an open public meeting on consumer directed advertising that FDA held in September 2003.85 The three recent Draft Guidances were: 1) Guidance for Industry. Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (directed only to CDER and CBER); 2) Draft Guidance for Industry and FDA: Consumer-Directed Broad- cast Advertising of Restricted Devices (directed only to CDRH);86 and 3) Draft Guidance for Industry and FDA: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. This last is the only guidance document which deals with drugs and devices together and addresses “disease awareness communications” by manufacturers, a form of advertising and promotion that is not covered by the labeling and advertising statutory rules in the FDCA and which FDA does not regulate. None of the three Draft Guidances have been finalized since their initial publications early in 2004. The 2004 “Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Medical Devices” did not deal with printed advertisements, but did provide an approach for companies to meet the requirements of 502(r) in their broadcast advertisements. Such advertisements are supposed to contain a brief statement describing the intended uses of the device as well as relevant warn- ings, precautions, side effects and contraindications.87 Because it is allegedly more difficult for a broadcast advertisement to contain all of this information than it is for a printed advertisement, FDA’s guidance document recommended that DTCA via broadcasts provide a way for consumers to gain convenient access to all of this information which appears in the printed label. This may be done in a broadcast advertisement by referring consumers to four other, different sources to obtain this information or its equivalent: 1) a toll-free number (e.g., a 1-800 number); 2) the manufacturer’s website; 3) a print advertisement which is running at the same time; 4) and a statement to viewing consumers that they should talk to their physicians (about the restricted medical device).88 Serious concerns about the recent FDA guidance documents remain. First, it is not clear why the Draft Guidance for Industry Brief Summary: Disclosing Risk 82 HHS, FDA, DDMAC, Guidance for Industry. Consumer-Directed Broadcast Advertisements. (Aug.1999). 83 HHS, FDA, Consumer-Directed Broadcast Advertisements Guidance, Questions and Answers, available at http://www.fda.gov/cder/guidance/1804.1&a.htm (last accessed Oct. 15, 2008). 84 Draft Guidance for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal; Availability, Fed. Reg. 69, 27 (Feb. 10, 2004) 85 Available at http://www.fda.gov/cder/ddmac/DTCmeeting2003.html (last accessed Oct. 12, 2008). 86 HHS, FDA, CDRH, Office of Compliance, Draft Guidance, Consumer-Directed Broadcast Ad- vertising of Restricted Devices, (Feb. 10, 2004). [hereafter CDRH Broadcast Guidance Document]. 87 21 U.S.C. 352(r)(2). 88 Id. 16 Food and Drug Law Journal Vol. 64 Information in Consumer-Directed Print Advertisements should exclude medical products from CDRH. As will be seen, restricted medical devices are advertised and promoted in print, either by the manufacturers themselves or by their surro- gate, the medical profession, in the form of either hospital or physician marketing. At present, there is no specific Guidance, draft or otherwise, which specifically addresses how sponsors can use FDA-approved patient labeling or highlights of the professional label for the restricted medical device to provide the best risk information in a brief summary format in consumer-directed print advertisement for medical devices. Guidance on this issue from FDA exists only for prescription drugs and biologics. The Draft Guidance recommendations apply to medical de- vices by inference only. Second, the standards for required information content for printed media and those required for broadcast media do differ. Even though broadcast advertisements for consumers are more expensive, more “intensive” in terms of attracting attention, more likely to minimize safety information,89 more distracting because of visual signals and more likely to be shown to a designated “target” marketing segment of the consumer population, the amount of required information concerning risk concepts from the medical product is greater for printed ads. DTC prescription drug ads in printed media must include the brief summary90 which generally contains all of the important safety risk concepts from the product’s approved label. Based on the assumption that broadcast DTC advertisements cannot convey this information, broadcast DTC advertisements may, instead of the brief sum- mary, make “adequate provision … for dissemination of the approved or permitted package labeling in connection with the broadcast presentation.”91 What does this adequate provision consist of ? According to the Guidance for Industry document,92 the acceptable information substitute by a DTC broadcast for the required printed advertisement substantive Brief Statement is a reference in the broadcast to the four items noted earlier: references to the device’s printed advertisement (if they can find it), the manufacturer’s website, a toll-free number where consumers can gather more information and a suggestion to contact their physicians (even though the physi- cian may have little or nothing to do with the restricted implantable device itself).93 These alone are for provision of critical safety information for a group of products (such as implantable surgical devices) which are perhaps more difficult to explain to consumers than drugs, and which (depending on the marketing application used) may actually have no original safety or efficacy information to begin with. Even if broadcast advertisements were less aggressive and less compelling prod- uct promotion than printed advertisements, this still would not be acceptable. The difference in current requirements between print and broadcast advertisements aside, there is no definitive data which either establishes that the information standard for print advertisements cannot be met in a broadcast advertisement or that there should not be a uniform standard—the current print standard—for all DTC advertising.94 89 Statement of Gary Ruskin, Executive Director of Commercial Alert, before FDA, Hearings on Direct-to-Consumer Prescription Drug Advertising, (Nov. 2, 2005). [hereafter Ruskin statement]. 90 The Act requires DTC advertisements to contain “information in brief summary relating to side effects, contraindications and effectiveness,” 21 U.S.C. § 352(n). 91 21 C.F.R. § 202(e)(1). 92 CDRH Broadcast Guidance Document, supra note 89. 93 Id. 94 No substantive data was provided during the 2005 Hearings on DTC prescription drug advertis- ing sponsored by FDA or the Sept. 2008 Congressional hearings on DTC medical device advertising. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 17 The question of whether FDA’s recommended guidance document approach for broadcast advertisements, which mimics that for DTC advertising of prescription drug broadcast advertisements, is just as good for restricted, implantable medical devices will be explored in subsequent sections of this article. If significant differ- ences exist between prescription drug and restricted medical device DTC adver- tising, the same regulatory approach will not be equally successful in protecting consumers. This “loophole” in required safety information is problematic for all FDA-approved medical products but is more severe for restricted, implantable medical devices. The harm from omission of equivalent information in a medical device broadcast advertisement is potentially greater for restricted medical devices, compared to prescription drugs, for reasons related to consumer knowledge base and intrinsic differences between complicated medical devices and drugs that will be explained in Section VI. IV. MAJOR RESTRICTIONS ON FDA’S REGULATION OF ADVERTISING AND PROMOTION OF MEDICAL DEVICES A. A restricted device is not necessarily a prescription medical device, a Class III medical device, one approved via a PMA, or one promoted just by the sponsor. FDA jurisdiction over the regulation of advertising and promotion of medical devices also differs from the degree of jurisdiction it has over prescription drugs. FDA regulation of medical devices is more restricted than it is for drugs. By statute, FDA can regulate advertising and promotion of medical devices only if they are restricted medical devices. By contrast, FDA regulates advertising and promotion of all prescription drugs. FTC jurisdiction over medical devices is thus broader, in a sense, than its jurisdiction over only over-the-counter drugs. The definition of a restricted medical device (as provided earlier in Section III) can be the source of some confusion. The term “restricted device” is not synonymous with “prescription device.” Nor does a restricted medical device does not have to be a device approved via PMA either; as a number of Class III devices reach the U.S. market via the 510(k) clearance mechanism. A restricted medical device also does not have to be a Class III device, though many are.95 There is one other surprising and unanticipated omission in FDA’s jurisdiction over restricted medical devices which points to another major difference between drug and medical device DTCA. It is no longer sufficient to say that FDA regulates the advertising and promotion of restricted medical devices because this statement does not really address who is doing the advertising and promoting. It would be more accurate to say that FDA regulates the advertising and promotion of re- stricted medical devices only when the advertising and promotion is being done by the medical device manufacturer. For restricted medical devices, particularly the implantable devices such as coronary artery stents which are being advertised and promoted directly to consumers, this generates an entirely different set of regulatory problems. For prescription drugs the issue of who is doing the advertising and promot- ing is a non-issue; with the exception of pharmacy compounding of prescription 95 Colonna, supra note 61. 18 Food and Drug Law Journal Vol. 64 drug products,96 virtually all advertising and promotion of prescription drugs to consumers is done by the pharmaceutical manufacturer. Neither physicians, hos- pitals, medical schools nor academic medical centers do any direct, or indirect, promotional activity for particular prescription drugs to consumers. Investigational drugs, or new prescription drugs or drug combinations undergoing clinical trials for new indications might be mentioned on a medical school/cancer center website, but even this rarely mentions the particular drug manufacturer. This is not the case with some restricted medical devices, particularly implantable restricted medical devices such as coronary artery stents and orthopedic implants. Examination of how some of these medical devices are promoted to consumers demonstrates a much different role for learned intermediaries, the healthcare in- stitutions they are affiliated with, or academic medical centers themselves. FDA does not have jurisdiction over these physicians or hospitals in this setting. This surrogate advertising has received little or no publicity, and is one of the major problems with the current regulatory framework for advertising and promotion of restricted medical devices. The question is: if learned intermediaries or their affili- ated institutions advertise that they use a restricted medical device, who regulates this advertising and promotion, and does it constitute an end-run around FDA regulation? This issue must now be addressed. V. DTCA OF PRESCRIPTION DRUGS AND RESTRICTED IMPLANTABLE DEVICES DIFFER: FOUR DISTINGUISHING FEATURES OF DTCA OF RESTRICTED MEDICAL DEVICES Because the general framework for regulating the advertising and promotion of prescription drugs and restricted medical devices is similar, the general assumption is that the problems faced by FDA in its efforts to regulate both industries are the same. This major assumption is not correct. A. DTCA of Prescription Drugs and Restricted Medical Devices Differs The differences between prescription drug and restricted medical device adver- tising and promotion are significant and problematic. The role played by learned intermediaries and the institutions they are either employed by or are affiliated with in promoting medical devices is far greater than it is for pharmaceuticals. There are fundamental differences between drugs and devices in terms of meaningful infor- mation content for consumers in advertisements, the core medical knowledge and familiarity consumers have with these products, and the likely ability of consumers to comprehend the limited safety and clinical information contained in the adver- tisement. There is also a dramatic difference in the amount of safety information provided between prescription drug and restricted medical device advertisements, and more importantly, in the type of safety information which is necessary for consumers. The advertisements themselves also differ greatly: there is dramatically less, or essentially no, critical safety information in many restricted medical device advertisements particularly for those implanted medical devices requiring techni- cally complex surgical implantation into the human body. 96 Bruce Patsner, Pharmacy Compounding of BHRT: A New Approach to Justify FDA Regulation of These Prescription Drugs, 63 FOOD AND DRUG L.J., 459 (2008). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 19 First a look at the issue of surrogate promotion by learned intermediaries. In general, particular prescription drugs are promoted to consumers exclusively by the manufacturers of the drugs themselves, with no role played by the physicians who prescribe them, or the physician medical groups, hospitals, academic medical centers or regional cancer centers where they may be administered to large numbers of patients. At most, the websites for pharmaceutical manufacturers may list all of the investigational or prescription drug or biologic drug trials available or being conducted; the websites of academic medical centers and cancer centers may list their investigational trials, and drugs available, but rarely mention the manufac- turer. Exceptions to this usually involve investigational biological drug products (cancer vaccines, gene therapy products) which are undergoing clinical testing.97 One obvious reason why pharmaceutical drug development and marketing is done exclusively by the manufacturers, with the role of the medical profession restricted to that of learned intermediary using the products at more of an arm’s length trans- action aside from participation in clinical trials is that the cost of bringing a new prescription drug to market in the United States is enormous.98 Without new drug development costs averaging close to $700 million or more from bench to bedside,99 the financial barrier to active new drug development and testing is so high that only manufacturers themselves can do this. When physicians are involved in this process, it is either as clinical investigators participating in clinical drug testing (a fact which may be made known to patients in promotional brochures or websites for a medical center),100 or they may be involved in speaker’s bureaus or educational symposia for physicians, but learned intermediaries themselves virtually never directly promote to consumers about the prescription drug products. It is different when one exam- ines medical devices and how the medical profession is involved in new restricted implantable medical device development, testing, and promotion. B. The Medical Device Industry—Learned Intermediary Relationship Is Unique, Less Arms-Length and Involves Surrogate Advertising Surrogate advertising may be defined as the promotion of named specific medical products to consumers by health professionals or institutions, either intentionally or otherwise, on behalf of the manufacturers. “Cutting-edge” implantable restricted devices are precisely the kinds of devices hospitals use to market their services and attract patients. This is seen in the way that individual physicians, surgical specialty groups (orthopedics, plastics, cardiovascular, interventional radiology or cardiol- ogy), hospitals, medical school and medical school-affiliated academic medical centers routinely advertise the availability of such devices to consumers, sometimes with pictures of the specialized members of the physician medical or surgical staff. This does not happen with prescription drug advertising. This surrogate advertising 97 An example of this is contained in Duke Medical Review 2008, a publication mailed out to physicians all over the United States and which can be perused in waiting rooms at Duke. On p. 22 there is a discussion of the CDX-110 vaccine which in undergoing testing at Duke. The clinical trial is being underwritten in large part by Pfizer Pharmaceuticals, and is mentioned in the article. 98 CONGRESSIONAL BUDGET OFFICE, RESEARCH AND DEVELOPMENT IN THE PHARMACEUTICAL INDUSTRY (2006). 99 Id. 100 For example, see the promotion brochure for Duke Medical Center or M.D. Anderson Cancer Center. Booher, Bridget, The future of the CDX-110 vaccine, DUKE MEDICINE REVIEW (2008). 20 Food and Drug Law Journal Vol. 64 may occur on billboards along major highways, in popular regional magazines101 distributed either nationally or in the catchment area for these medical institutions, and occasionally on television. All of this is part of the costly and essential mar- keting strategy these institutions or physicians employ to differentiate themselves from their competition and to attract patients. This marketing of devices and health providers in tandem occurs because of the unique role learned intermediaries and their institutions have in implementing the use of cutting edge restricted medical devices. Advertising surgical services sometimes requires advertising specific medi- cal products. This is not true for prescription drugs. One need not go far to find examples of surrogate advertising from different parts of the United States and from individual physicians, surgical groups or medical cen- ters. For example, the Providence Medical Center in Anchorage, Alaska advertises102 the exclusive availability of the DaVinci robotic surgical platform in its website for patients. This format allows this public hospital to market the superiority of its medical device equipment directly to consumers, while at the same time providing free advertising not only for the product but for the manufacturer as well. Adver- tisements for this type of minimally invasive robotic surgical technology invariably tout its superiority in minimizing blood loss and length of hospitalization, yet there is no way that a consumer would know that there is little or no data demonstrating the superiority of this expensive equipment over conventional laparoscopic surgical techniques103 in many of the areas (surgical treatment of gynecologic cancers, for one) in which it is used and which may be more universally available. It is not just in internet-based broadcast promotions for medical centers that proxy advertising for restricted medical devices occurs. Similar advertisements for this robotic surgical system appear in print in metropolitan magazines in Texas for major cancer centers such as M.D. Anderson in Houston and Baylor Medical Center in Dallas, invariably accompanied by a picture of one of the surgeons with presumed expertise in that surgical technology.104 It is not just regional academic or cancer centers which advertise medical device technology to attract patients; individual surgeons, interventional cardiologists, radiologists, neurosurgeons, orthopedic surgeons or groups of such physicians advertise their medical services directly to consumers, sometimes highlighting the restricted medical devices, and occasionally the manufacturer, which they use. A perusal of the October 2008 issue of D (Dallas/Forth Worth) Magazine’s “Top Doctors 2008” issue105 nicely illustrates this, though the same point could be made 101 Boston, Los Angeles, Wash., D.C., New York, Chicago, Houston, Philadelphia, Dallas-Fort Worth are all cities which have “metro” magazines (e.g., NY Magazine, Boston Magazine, Washingto- nian Magazine) which not only carry this type of advertising by physicians, surgical groups, university hospitals and regional medical centers in every issue but all have a much-anticipated “Best Doctor’s” issue which is an especially valuable marketing tool. 102 Providence Health & Services, Robotic-Assisted Surgery Now Available, available at http://www. providence.org/alaska/pamc/surgery/robotics.htm (last accessed Oct. 6, 2008). “Providence has installed the DaVinci surgical robotics system manufactured by Intuitive Surgical, Inc. of Sunnyvale, California … It is the best in patient care … Providence has a long history of bringing technology to the state, ensuring Alaskans have access to the very best technology available, right here at home.” 103 At the time of this writing no prospective, randomized study comparing conventional laparo- scopic cancer surgery with robotic-assisted surgery has been performed demonstrating either superior clinical outcomes or cost-savings. It may be true that a manufacturer’s claims may be supported by their own data on file which has never appeared in a randomized study, but even if so the absence of peer-review of such data does not help the situation. 104 The University of Texas M.D. Anderson Cancer Center, Making Cancer History®: Advance- ments in Minimally Invasive Cancer Surgery, TEXAS MONTHLY (July 2008), p 76. 105 D. DALLAS/FORTH WORTH MAGAZINE, Volume 35 No. 10, Top Doctors 2008 [hereafter D Magazine]. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 21 for the “best doctors” issue of New York Magazine, Los Angeles Magazine, Boston Magazine, or any of the other major metropolitan area city magazines which allow healthcare professionals, hospitals and academic medical centers to advertise their medical and surgical services directly to consumers. Examination of the full and half-page advertisements reveals advertisements by ophthalmic surgeons for specific Lasik machines106 (advertisements which interestingly note that this newest device is FDA-approved even though the very same type of claim in an advertisement by a manufacturer would render the device misbranded if the device reached markets via a 501(k) clearance); advertisements by neurosurgeons107 for BrainSUITE iMRI advanced operating room equipment as well as Gliadel chemotherapy wafers for brain tumors (a consumer doing an internet search on either immediately comes up with Baylor Medical Center’s press release108 that it is the first in the United States to acquire GE Healthcare’s MRI surgical suite and MGI Pharma’s advertisement109 for the chemotherapy wafer); advertisements110 by spine surgeons for the PRESTIGE artificial disc for the neck (also noting it is FDA-approved) and Maverick artificial lumbar disc replacement; advertisements111 by general surgeons at the Nicholson Clinic for Obesity Surgery at Baylor Regional Medical Center in Plano for the Johnson & Johnson Swedish Lap Band bariatric surgery device and advertisements by obstetri- cian-gynecologists advertising multiple specific manufacturers’ medical devices for endometrial ablation to treat abnormal uterine bleeding.112 The use of DTC advertis- ing of particular medical device equipment appears to be most prevalent, and most competitive, in the world of ophthalmologists, where “promotion is okay.”113 As a rule, it appears that the only restricted, implantable medical devices being advertised and promoted to consumers are those for which there are alternatives, particularly medical alternatives or non-surgical therapies, to use of the device itself. All of these physicians and/or their affiliate institutions use their access to restricted medical device technology to promote their medical/surgical services as integral parts of their marketing efforts to attract patients. In so doing, it is routine for both the name of the medical device, as well as the name of the company which developed the device (and on some occasions the city and state where the medical device manu- facturer is located), to appear in the medical center or physician advertisement. By any name, this is surrogate marketing of the medical device by the medical profes- sion, even if the intention is to market the hospital or the doctor. The name of the manufacturer sometimes is, but need not be, mentioned along with the name of the product, though it sometimes is. In the internet age, a consumer reading the adver- 106 Id. at 159. 107 Id. at 202. 108 Imaging Economics Press Release, Baylor University Medical Center First in US to Acquire Combination BrainSUITE) iMRI and GE Healthcare MR Surgical Suite, (Sept. 29, 2008), available at http://www.imagingeconomics.com/press_release.asp?id=1021181 (last accessed Oct. 17, 2008). 109 MGI Pharma, Products, Gliadel (polifeprosan 20 with carmustine implant) Wafer, available at http://www.mgipharma.com/wt/page/gliadel (last accessed Oct. 17, 2008). 110 D. MAGAZINE, supra note 105, p. 214. 111 Id. at 237. 112 Id. 113 Rundle, Rhonda L., Eye Doctor to Elite Blazes New Trail in Selling Surgery. In a Patient-Pays-All World, Dr. Maloney Treats Lasik Like a Luxury Product, THE WALL STREET JOURNAL, (Oct. 26, 2004), at A1. This article highlights the integral role promotion of the latest Lasik (laser-assisted in situ keratomileusis) equipment to consumers to generate business. “Although insurance almost never pays for it, more Lasik surgeries are performed every year than nose jobs, face lifts or tummy tucks … including 1.2 million last year … ‘Promotion is OKAY’, says Bradley Straatsma, chairman emeritus of UCLA’s Jules Stein Eye Institute. ‘Part of our American medical system is to inform the public of their options and to try to get information to them that is valid and accurate.’” There was no comment on the lack of complication rates, and minimization of complications per se, in such advertisements. 22 Food and Drug Law Journal Vol. 64 tisement is literally only one click away from the medical device company website once a search on the product name is done. Whether the concomitant marketing of device and physician/hospital is intentional or one is merely “piggy-backing” on the other is irrelevant, though one would assume that a hospital or physician could not name a medical device and its manufacturer by name without either permission to do so or a specific agreement in place that it actually do so.114 Another difference between prescription drugs and restricted medical devices in the role learned intermediaries play in DTCA concerns the active participation of physicians or hospitals/universities in the actual drafting of the advertisement. In a depressing commentary on a blurring of roles, a recent study on internet DTCA of “minimally invasive hip replacement” revealed that the content of the internet advertisements for such surgery and its accompanying manufacturer’s products were written by a hospital/university or a private medical group for about 70 percent of the advertisements.115 None of this physician or medical center proxy advertising of restricted medical devices for the respective medical device manufacturer is regulated by FDA because none of this advertising and promotion is being done directly by the manufacturer. The regulation of this physician and hospital advertising instead is left to the medical board of the state in which the ad originated, as well as relevant state laws on decep- tive trade practices and consumer protection from false advertising claims.116 1. The Unique Role Surgeons, Hospitals and Academic Medical Centers Have In Development of and Reimbursement for Restricted Medical Devices There is a critical difference between the medical profession-restricted medical devices industry relationship and medical profession-prescription drug relationship in that physicians, medical schools and hospital systems may be much more involved in the development of high-end medical device technology and the marketing of that technology than they ever would be for pharmaceuticals. This is not to say that some medical centers have not partnered closely with the pharmaceutical industry in the clinical testing of new drugs, nor that some institutions such as The National Institutes of Health (NIH) have not forged stronger ties in translational research.117 114 This may be handled through a grant from the manufacturer supporting the advertisements. 115 Jaffe, supra note 26. THE ORTHOPEDIC AND DENTAL INDUSTRY NEWS cites a study UCSF Or- thopedic Surgeon Kevin Bozic did on internet DTCA. “He did a search for ‘minimally invasive hip replacement’ on three popular search engines, excluded duplicate matches and examined the top 50 sites. A hospital/university or private medical group wrote the content for about 70 percent of the sites, and of the original 150 sites, 45 percent allowed the reader to make an appointment. When looking at risks and benefits, 91 percent claimed a shorter recovery time, where as only 13 percent even described risks. Only nine percent of the sites referenced some peer-review literature.” 116 MPA §153.002. For example, in Texas the Medical Practice Act (MPA) provides regulations on physician advertising and states that physicians may not engage in false, misleading or deceptive adver- tising not readily subject to verification. These are codified in the Texas Administrative Code, Title 22, Part 9, Chapter 164 (Physician Advertising, §§ 164.1-164.5). The state law provisions on advertisement content are more specific, as well as more expansive, than the federal regulatory matrix of statutes and guidance documents which FDA uses. For example, there cannot be material misrepresentation of fact or omission of a fact necessary to make the statement as a whole not materially misleading, nor can there be either representation likely to create an unjustified expectation about the results of a healthcare service or procedure, testimonials from physicians or patients, or representation that causes confusion or misunderstanding as to the credentials, education or licensure of a healthcare professional. 117 HHS, Moving Medical Innovations Forward—New Initiatives from HHS, FDA Critical Path and Other Initiatives, (Jan. 2005). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 23 This is still dramatically different from the in-house development of new pharma- ceuticals, something few if any medical schools and academic medical centers have the financial or bench laboratory resources for. The medical device industry, however, is designed around the notion of predicate medical devices, and approvals by CDRH favor “follow-on” technologies. Academic medical centers, such as the Cleveland Clinic,118 and their affiliated medical schools with biotechnology programs, have moved towards bringing medical device technology development by their own doctors and researchers to market.119 In short, there may be a much greater investment in the intellectual property of the restricted medical device than there ever would be for a pharmaceutical,120 particularly for implantable devices for orthopedic and cardiovas- cular indications. Patients are unlikely to be aware that the relationship between the medical institution and the cutting-edge medical device technology it is using may not be arm’s length. Consumers will also be unaware of the financial interest the medical organization has in particular restricted medical device development, widespread use, and marketing of medical devices which were developed in-house. This also means that there is greater potential for conflict of interests between the best interests of the patient and developing in-house restricted medical device technology which a healthcare institution has a non-arm’s length financial interest in.121 This highlights a final difference between prescription drugs and restricted de- vice advertising involvement of learned intermediaries which concerns financial incentives for physicians, both for direct-to-physician as well as DTC advertising. The current payment system between medical device companies and surgeons or hospitals creates financial incentives to perform the surgery or procedures that implant the devices. Although physicians presumably act only in their patients’ best interests, there is no question that surgeons and interventional cardiologists and radiologists only get paid when they are operating or implanting devices. There already is a small but growing lay literature questioning the objectivity of physi- cian “learned intermediaries” in fully informing patients of the risks of implant surgery122 as well as the skewed nature of monetary incentives showered on promi- nent surgical groups.123 The only comparable situation for prescription commercial pharmaceuticals is in medical oncology, where medical oncologists have an incentive to continue treating patients with expensive chemotherapeutic agents, even near 118 Morona, J., Clinic-led heart center commits to $2.90 million in grants, (Sept. 8, 2008), available at http://blog.cleveland.com/medical_impact/2008/09/clinicled_heart_center_commits/print.html (last accessed Oct. 6, 2008). 119 Pettypiece, Shannon, Clinic spinoffs gain momentum for ‘06, CRAIN’S CLEVELAND BUSINESS, (Dec. 19, 2005), available at http://www.crainscleveland.com/apps/pbcs.dll/article?AID=/200512219/ SUB/51216024&te (last accessed Oct. 6, 2008). 120 MEDICAL DESIGN, Cleveland Clinic Hosts 2005 Medical Innovation Summit, (Oct. 1, 2005), available at http://www.printthis.clickability.com/pt/cpt?action=cpt&title=Cleveland+Clinic+hosts (last accessed Oct. 6, 2008). 121 Schwitzer, Gary, Univ. of MN School of Journalism & Mass Communication, Health News Blog, Cleveland Clinic’s Stunning Conflict of Interest Story, (Dec. 12, 2005), available at http://www. blog.lib.umn.edu/schwitz/healthnews/034015.html (last accessed Oct. 6, 2005). “The Cleveland Clinic for years has touted a procedure for atrial fibrillation, calling it the ‘AtriCure procedure’… A venture- capital partnership that the Clinic helped found and invested in owns about 4.1 percent of AtriCure’s stock … another Clinic surgeon who performs the AtriCure procedure is a paid consultant to the company … The Clinic did not disclose these ties to AtriCure to patients on whom it performed the AtriCure procedure.” 122 Russell, John, Docs bristle at suggestion of kickbacks,; Feds probe orthopedic surgeons’ fees from artificial devices makers, INDIANAPOLIS STAR, (Nov. 12, 2007). 123 Wall Street Journal Health Blog posting reporting that 40 surgeons or surgical groups each received at least $1 million in payments from medical device manufacturers in 2007, available at http:// blogs.wsj.com/health/2007/10/31/device-makers-post-payments-to-docs-online/?mod=WSJBlog. 24 Food and Drug Law Journal Vol. 64 the end of their lives when patients have failed multiple lines of therapy and have little chance of significant prolongation of life and no chance of cure.124 The effect of all of these differences is that the physicians and medical institu- tions act as surrogate advertisers and promoters for some restricted medical devices for the manufacturers of these products. Presumably, any specific mention of the manufacturer could only be done with permission, but sometimes the developer of the technology and the manufacturer is the learned intermediary or affiliated medi- cal institution. This is not only promotion of a particular device, and sometimes a particular company, but if the medical institution is prestigious enough, may create the appearance of the superiority of one device over another. For example, the Cleveland Clinic publicly announced that of the four drug-coated cardiac stent manufacturers (Boston Scientific, Johnson & Johnson, Medtronic, and Abbott) on the market, cardiologists at the Clinic would not be using medical devices from Boston Scientific.125 Even though the reason for this decision was not necessarily medical (the prior deal with Boston Scientific had recently expired) and there is a lack of substantive data directly comparing all of the different drug-eluting stents, this type of announcement is both positive advertising for three of the manufactur- ers and negative for one of them. By contrast, no similar announcement restricting the Cleveland Clinic formulary for anti-cholesterol prescription drugs on the U.S. market (more than half a dozen are available) was made. C. There are Signiﬁcant Limits on Consumer Product Information and Comprehension of Restricted Implantable Medical Device Advertisements DTCA promotion of prescription drugs, and by extension restricted medical de- vices, is at best an uneasy balance among claimed protection of commercial speech for manufacturers under the First Amendment, a Supreme Court which generally favors more information for consumers over restriction of information (even if the information may be potentially misleading), and an understandable concern on the part of FDA that advertising be more balanced and educational than misleading and promotional. Although blatantly false or misleading commercial speech re- ceives no First Amendment protection,126 potentially misleading information may be permitted if it is accompanied by a disclaimer even though the value of such disclaimers, at least in the food and drug arena, is dubious at best. Clearly there are more issues at stake here than just lack of regulation of the medical profession by FDA and limits on FDA jurisdiction over DTCA of select medical devices. There are serious issues surrounding informed consent, the vulner- ability of patients in general at the hands of the medical profession when faced with 124 Harrington, Sarah Elizabeth & Smith, Thomas J., The Role of Chemotherapy at the End of Life: “When is Enough, Enough?”, 299 JAMA 2667 (2008). See also Wright, Alexi A., Zhang, Baohui, Ray, Alaka, et. al., Associations Between End-of-Life Discussions, Patient Mental Health, Medical Care Near Death, and Caregiver Bereavement Adjustment, 300 JAMA 1665 (2008). 125 Kamp, Jon, Cleveland Clinic Foregoes Boston Scientific Stent, THE WALL STREET JOURNAL, (Aug. 13, 2008) at B1, available at http://online.wsj.articles/SB121859886184436023.html?mod=2_1566_leftbox (last accessed Oct. 18, 2008). 126 DANIEL A. FARBER, THE FIRST AMENDMENT (2D ED. (2003)). The current test for regulation of commercial speech was announced in Central Hudson Gas & Elec. Corp. v. Public Service Comm’n, 447 U.S. 557 (1980). The threshold inquiry which must first be met is whether the regulated speech is false or misleading, or concerns an illegal activity. If either is the case the speech receives no constitutional protection. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 25 potentially life-threatening conditions, and concerns over consumer vulnerability and exposure to “medical” information that are too paternalistic. Also, some of the issues involved in DTCA of select restricted medical devices cannot be separated from the general problems of over utilization of medical technologies for clinical conditions equally well treated by lifestyle change instead of a pill or a device, and of the problems with the way we reimburse physicians and provide incentives for them to prescribe more drugs and implant more devices in the absence of federal oversight which assess technology and methodically evaluates cost-benefit. Although a full exploration of all of these issues is beyond the scope of this article, the fact that they are concerns at all simply serves to emphasize just how different DTCA of restricted medical devices is when compared to DTCA of pharmaceuticals. The “safety valve” and default protection for manufacturers for DTC advertis- ing for any medical product is the learned intermediary doctrine.127 Even within the confines of printed advertisements, which generally allow manufacturers to potentially convey more, and more balanced, safety and efficacy information to consumers than short broadcast advertisements on television and radio, all parties concerned predicate their content on the understanding that consumers will seek additional information about the product from their physicians—the “learned intermediaries”—who are generally held responsible for this information because they are responsible for knowing the contents of the FDA-approved label and (presumably) have both read it and understood it. This approach may work, with some difficulties, for DTCA of prescription drugs, but there are problems when it is applied to DTCA of restricted medical devices even if one ignores the greater financial incentives, greater development role, and greater promotional role which learned intermediaries have for restricted medical devices just described. There are other reasons why the learned intermediary is a less viable source of information for consumer; these reasons revolve around several basic facts: 1) consumers often may not know as much about medical devices and the surgical procedures involved in their implantation as they do about prescrip- tion drugs;128 2) the “learned intermediary” from whom they would need to obtain meaningful and balanced information is not the primary care physician (internist, family practitioner, even obstetrician-gynecologist) who normally provides infor- mation, but rather is another physician at least one degree of separation away to whom they would have to be referred and who, in the absence of a referral, they are unlikely to be able to call directly; 3) primary care physicians are likely more limited in knowledge about medical devices, the surgical procedures involved in their use, labeling information about the device and are more constrained in their ability to obtain such information because there is no equivalent compendium 127 The phrase “learned intermediary” was coined in Sterling Drug, Inc. v. Cornish 370 F.2d 82, 85 (8th Cir. (1966)). The doctrine holds, at least as far as pharmaceuticals are concerned, that a prescrip- tion drug manufacturer takes care of its duty to warn the eventual user of its drug product’s risks by supplying physicians with information about the drug. Prescribing physicians are expected to know about potential dangers from a drug’s use by being familiar with the FDA-approved label, package inserts, and are presumed to be in the best position to provide individualized warnings to a particular patient based on knowledge about the individual patient’s medical condition and whether the drug is suitable for him/her. 128 There will be exceptions to this statement of course, with limitations. The mechanism of ac- tion of some implantable devices such as an artificial hip or knee may be easier to understand than the complex pharmacology of some pharmaceuticals such as SSRI’s. Despite this, it may be easier for consumers to understand the side effects of a drug (even if they do not understand the mechanism of action of a drug) than to appreciate the risks of surgical implantation and the complexities of de- vice-related surgery, items which are essential to the understanding of the safety profile of restricted, implanted medical devices. 26 Food and Drug Law Journal Vol. 64 of labels for medical devices, such as the Physicians’ Desk Reference (PDR)129 for prescription and over-the-counter drugs; and lastly 4) critical safety data for im- planted, restricted medical devices is not independent of the learned intermediary itself,130 unlike adverse event data for pharmaceuticals. One cannot present vital safety information about the risks and complications of some medical devices in a vacuum, independent of performance information on the learned intermediary himself (or herself), and their affiliate medical institutions. 1. Limitations on Consumer Knowledge Consumers cannot know enough about restricted medical device safety and efficacy issues which arise from any printed or broadcast advertisement, at least compared to what they know or might know about pharmaceuticals, because of the nature of the information required to understand an implantable restricted medical device in a meaningful way. This needed information is not only just medical, but is also surgical and in some cases engineering. Consumers (and many physicians) are likely unaware of this, and have little or no idea that some potentially dangerous medical devices or equipment may have been approved for marketing without any independent, con- firmatory safety or efficacy information being submitted to the agency at all.131 Not only are consumers unaware of the entire predicate medical device-510(k) clearance aspect of restricted medical device approval, consumers may also be unaware that the device being promoted to them may have not been compared a predicate medi- cal device that is the gold standard medical device, or that the device on which the comparative safety and efficacy information is based is no longer very similar to the restricted device they are going to be exposed to. If for no other reason, it is impos- sible for a DTCA for some restricted medical devices to have fair balance of risk information.132 Insofar as the referenced Cypher coronary artery direct to consumer television broadcast ad is concerned, there is no reasonable way that the risk infor- mation presented could approach the brief summary requirement that each specific side effect and contraindication be presented to the viewing consumer. The average health consumer watching a DTCA for a restricted medical device may have an inherently more complicated decision tree than he or she does for a prescription drug advertisement for medical conditions which have medical and well as surgical therapies.133 This makes any brief statement or equivalent included in the advertisement more brief, and the information inherently less fairly balanced. For a consumer with a medical condition such as high cholesterol or high blood pressure 129 PHYSICIANS’ DESK REFERENCE (62nd Ed. (2008)). The PDR is a compilation of pharmaceutical manufacturers’ prescribing information (drug labels included as a package insert). The PDR is updated annually, is available online, and though not an official medical publication (it is supported in large part by the pharmaceutical industry) it is an indispensable tool for office-based medical practice. 130 Patients rely on the ability of their physicians to practice good medical practice, both in pre- scribing and monitoring medications correctly as well as implanting medical devices. There are different degrees of dependence. 131 In this set of circumstances, consumers would actually have to identify the predicate medical device and find the safety and efficacy information for that device, assuming they were aware of the predicate medical device issue at all. 132 Drugs are usually not compared against other drugs in clinical trials unless the goal of the study is to enable the manufacturer to make a superiority claim. Restricted implanted medical devices which obtain 510(k) clearance, on the other hand, are always compared to the predicate device. 133 There clearly are some medical conditions (e.g., a cerebral aneurysm) which can only be treated surgically and for which no medical therapy is available. Even if these surgical treatment-only conditions are treated with restricted, implantable medical devices, such devices are not generally directly-advertised to consumers, in part because there is no drug treatment alternative, as there is for coronary artery disease or a knee replacement. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 27 only, the decision matrix is do nothing, lifestyle change only, lifestyle change plus drug, life style change plus alternative drug, or life style change plus combination of drugs. For a patient with high-cholesterol or high-blood pressure who may or may not have underlying coronary artery disease and to whom recent DTCA coronary artery stent device ads have been targeted, the decision tree necessarily involves all of the decisions which have to be made for drug therapy alone (since that is one of the alternatives to the medical device) as well as deciding about the advertised device, alternative medical devices (there are at least three others on the market, some plain metal and some drug-eluting), or using both medical therapy and the device. The consumer medical device decision is thus inherently more complicated because restricted medical devices are more likely to be used in patients who are already on medical therapy, not being managed optimally on medical therapy, or who are more likely to be symptomatic. In the latter situations DTCA ads for medi- cal devices do not have the same function as prescription drug advertisements for asymptomatic individuals who may not be aware they have a disease at all. Most individuals on the receiving end of implantable, restricted medical devices are aware of their diseases, are more likely to have already had medical therapy, and to make a balanced decision would need to be knowledgeable enough to compare medical data on medical therapy versus surgical therapy. Medical device ads rarely, if ever, discuss medical therapy alone as a meaningful alternative to use of the restricted device, and certainly do not go into the surgical complications which might occur as a result of device implantation. Even if they did, the learned intermediary they would first be calling is not a surgeon or an interventional cardiologist. The little formal investigation into consumer comprehension of DTCA of re- stricted medical devices would seem to confirm all of these concerns.134 Evaluation of advertisements for a group of implantable medical devices (coronary artery stents, knee and hip joint replacements, implantable defibrillators, breast implants) revealed an absence of risk information in many advertisements, heavy reliance on patient “testimony” as to the merits of the device, and consistent reporting of twice as many benefits as risks, consistent with the same pattern seen in DTCA of prescription drug advertisements.135 Because consumers are not used to seeing advertisements for restricted medical devices, particularly implantable ones, and have no information framework for understanding such advertisements, they lack the reference point of other advertisements for comparison. The consumer market may be more targeted for a restricted medical device advertisement (middle-aged men watching football on television are the perfect audience for a medical device used in individuals who either have or are at risk for coronary artery disease), but most consumers are not knowledgeable enough to know if they are appropriate candidates. This is more of a problem for a device than a prescription drug because the use of restricted devices often follows use of prescription drug therapies. Lastly, the statement “Talk to your doctor” which appears in all print, television and internet advertisements for drugs, and in the few for devices, is simply not as re- alistic where medical devices are concerned. Which physician should the patient talk to? Many restricted devices are used by physicians to whom patients are going to be 134 Day, Ruth S., Direct-to-Consumer Ads for Medical Devices: What Do People Understand and Remember? Testimony at Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008). 135 Id. “Overall, risk information is seriously disadvantaged relative to benefits in medical device ads-the techniques used to present them often render them lower in cognitive accessibility.” 28 Food and Drug Law Journal Vol. 64 referred by other physicians, and who will not spend, as a rule, nearly as much time explaining things to patients. It is not the same as for drugs, where therapy is being prescribed by a general internist, internal medical sub-specialist (e.g., oncologist, cardiologist), family practitioner or other primary care practitioner. In the absence of any substantive, good data on consumer comprehension of restricted, implanted medical device advertisements, the presumed education benefits of DTCA for such devices claimed by their manufacturers must at present be speculative. 2. Learned Intermediaries May Be Less Learned or Less Arm’s Length from the Medical Device Industry The safeguards and required information which are inherent in DTC broadcast advertising for prescription drugs (the “talk to your doctor” statement, an 800 number for consumers to call, a website about the product to go to on the inter- net) are less meaningful in the restricted medical device context. The net result must be that the device information must be less interpretable and educational for consumers. Most physicians do not have an engineering background and primary care physicians are neither surgeons nor internists who perform the interventional procedures using implantable restricted medical devices such as coronary artery stents. The first source of medical information for the consumer is going to be a primary care physician, but for restricted, implantable medical devices he or she will not be the best source. The most knowledgeable medical person would be the surgeon or interventional cardiologist to whom the consumer would have to be referred by the primary care physician. This is not the person whom the advertise- ments tell the consumer to consult, if the DTCA tells the consumer exactly who they should talk to at all. Primary care physicians are unlikely to understand the critical engineering and safety aspects of restricted implantable medical devices, and will understand less about of the fundamentals of the device and the surgery involved in its placement, than they will understand about the fundamentals of a drug they might prescribe. In all likelihood they do not know the surgical literature on an implanted, restricted medical device, or that for alternative devices, well enough to counsel a patient with a safety or efficacy question about the restricted device the patient saw advertised. This situation is made unavoidable because of the extensive, essential engineer- ing (electrical, mechanical, other) data submitted during the approval process for restricted medical devices if the device’s marketing application was a PMA, the absence of this information if the device were marketed through a 510(k) clearance, and the surgical nature of many restricted medical devices. Because of these learned intermediary knowledge limitations, the entire notion of DTC advertising for restricted medical devices is inherently more problematic for devices than it is for prescription drugs. Most medical professionals are inher- ently less learned on surgical and implantable devices than they are about pharma- ceuticals. The situation is further aggravated by the absence of a readily available, comprehensive PDR-equivalent desk reference for medical devices to serve as a ready compendium of labeling information for restricted devices. This results in a dramatic difference in the amount of standardized information available to consumers and physicians alike. Even if surgeons and interventional cardiologists and radiologists were willing to talk to patients prior to a referral for a procedure, 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 29 there is no guarantee that they will have actually read the medical device label, or if they read it follow the instructions.136 Ironically, all of this should make a learned intermediary defense offered by restricted medical device manufacturers for tort actions against them in state court less reliable than when it is offered by pharmaceutical manufacturers. The opposite is the case. Because of the express preemption protection for manufacturers of some restricted medical devices affirmed in the recent Riegel v. Medtronic137 deci- sion under the preemption clause of the 1976 Medical Device Amendment to the 1938 FDCA, at the end of the day only physicians can be sued for tort damages for injuries from some of the most dangerous and complicated medical devices on the market. The pending Wyeth v. Levine138 decision in the prescription drug arena will also likely leave learned intermediaries as the only ones standing without a chair when consumers are injured by pharmaceuticals they sought out because of advertisements for the products in print and on television. 3. The safety calculus is broader and requisite safety information different for restricted medical devices. The data shows that device ads are more likely to omit important safety information. The results of the first of the two studies139 of the actual risk-benefit content of direct-to-consumer advertisements for restricted, implantable medical devices (such as total knee replacement or TKR) and consumer comprehension of the same were not encouraging. In general, implanted medical device ads minimized or omitted significant safety information140 and consumers were twice as likely to remember benefit information than risk information. In the context of a procedure such as TKR, where the morbidity and mortality for a procedure that is performed more than 600,000 times a year worldwide are both relatively common,141 and a major contributor to rising healthcare costs,142 this data on poor consumer comprehen- sion, and deficient safety content of advertisements, should give FDA and Congress pause. In the context of what is now aggressive promotion directly to consumers, the lack of important, balanced safety information is both an unacceptable and a direct challenge to the public health mission of FDA itself. 136 This was exactly what happened in Riegel v. Medtronic, Inc. Although the medical device manu- facturer was sued, the interventional cardiologist who used the inflatable coronary artery balloon failed to follow the specific instructions in the device label for either patient eligibility or balloon inflation pressures. 137 Riegel v. Medtronic, 552 U.S.__ (2008). 138 Wyeth v. Diana Levine, No. 06-1249 U.S. Supreme Court (2008). 139 Aikin, Kathryn J., DDMAC, FDA, Attitude and Behaviors Associated with Direct-to-Consumer Advertising of Prescription Drugs: Summary of Survey Results, FDA Scientific Rounds, (Mar. 30, 2005), available at http://www.cdernet.cder.fda.gov/dtd/Rounds/Fall04/bg3-30.htm (last accessed Mar. 30, 2005). 140 Id. 141 Soohoo, Nelson F., Lieberman, Jay R., Ko, Clifford Y. & Zingmond, David, Factors predicting complication rates following total knee replacement, 88(3) J. BONE JOINT SURG. AM. 480 (2006). Between 1991 and 2001 a study was performed on the 222,684 cases of TKR in California: 1,176 deaths (0.53 percent), 1,586 infections (.71 percent), and 914 pulmonary emboli (0.41 percent), with worse figures in elderly patients with co-morbid conditions or when surgeries were performed in institutions with lower surgical volumes. 142 Statement of Kevin J. Bozic, MD, MBA, at Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail. cfm?id=303085 (last accessed Sept. 30, 2008). [hereafter Bozie statement]. “A ten percent decrease in the number of revision hip and knee arthroplasties in 2005 would have saved the Centers for Medicare and Medicaid Services (CMS) over $100 million that year.” [hereafter Bozic statement]. 30 Food and Drug Law Journal Vol. 64 The second and only other well-designed study143 was by a large group of ortho- pedic surgeons who examined the impact of DTCA in their specialty. The results of this study confirmed the limitations of essential safety information consumers get in DTCA advertisements for implanted medical devices, and noted further problems with the advertisements not mentioned in other studies. The orthopedic surgeons found that the advertisements do not inform patients about differences in product design, composition of materials, strength of the devices, proper clinical indications or the need for and frequency of requisite replacement.144 Investigators pointed out that individual surgeon group, and hospital, variations in infection rates, anesthetic complications, or mortality rates related to implanted medical restricted medical device use were absent from DTCA for these orthopedic devices. The same could be said for the advertisements for coronary artery stents. This data highlights another critical difference between prescription drug and restricted medical device advertising on product safety. For prescription drugs the adverse events and critical safety information are more independent of the actions of the practitioner, in the sense that a prescribed drug’s adverse events and critical safety information about the drug are actions independent of which physician is prescribing it.145 For restricted medical devices (particularly implanted restricted medical devices such as spinal bone replacements, TKR, or coronary artery stents) the exact opposite is the case. The safety issues and critical safety information for restricted medical devices is broader than it is for prescription drugs. The critical safety information a consumer would need about use of a restricted implanted medi- cal device is a direct function of both the institution in which the surgery is taking place, and the skill and experience of the surgeon or interventional cardiologist. In an absolute sense, restricted medical device safety information is tied directly to the learned intermediary in a manner in which it is not for drugs. Restricted medical device safety information is thus a function of all of the issues surrounding pay for performance146 and not paying for medical errors,147 particularly infectious complications following orthopedic and cardiac surgery. A consumer viewing a DTCA for a restricted medical device cannot possibly make an intel- 143 Bozic, Kevin J., Smith, A.R. & Hariri, S., et. al., The Impact of Direct-to-Consumer Advertising in Orthopedics, 5 CLIN ORTHOP RELAT. RES. 458 (2007). 144 Id. The recent travails of New England Patriots quarterback Tom Brady highlight this point. At the time of this writing ABC Nightly News on Friday, Oct. 24, 2008 noted that Mr. Brady was about to undergo his second surgery to treat infectious complications of his recent knee surgery, with the potential of long-term loss of function. Printed advertisements for surgical groups for orthopedic implant procedures never mention the possibility of infectious complications, and more importantly, never provide their own infectious morbidity or complication rate in advertisements to consumers, thus omitting perhaps the most critical information a consumer would need in order to make an educated decision about such surgery or a restricted medical device such as a TKR. 145 Again, as noted, physicians can prescribe drugs or monitor drug therapy negligently. Even so, safety data on individual surgeons, and hospital, complication data for implantable restricted devices may be more accessible than data on physician medication-related complications. The recent initiatives on pay-for-performance will almost certainly guarantee that more data will be available for consumers on hospital and individual surgeon complication rates and experience than there will be for primary care physicians who provide non-surgical therapies. See Bruce Patsner, Preventable Hospital-Acquired Errors: Lowering Costs by Refusing to Pay, HEALTH LAW PERSPECTIVES (June 2008), Univ. of Houston Law Center, available at http;//www.law.uh.edu/healthlaw/perspectives/homepage.asp (last accessed Jan. 14, 2009). 146 Mitka, Mike, Public, Private Insurers Refusing to Pay Hospitals for Costs of Avoidable Errors, 299 JAMA 2495 (2008). 147 Rosenthal, Meredith B., Nonpayment for Performance? Medicare’s New Reimbursement Rule, 357 N. ENGL. J. MED. 1573 (2007). Five of the eight “never events” (object left in patient during surgery, air embolism, catheter-associated urinary tract infection, vascular-catheter-associated infection, and mediastinitis after coronary-artery bypass grafting) are occurrences directly or indirectly related to use of restricted medical devices. There is enormous public pressure for consumers to know the safety “report card” for institutions, and for surgeons. This information is precisely the type of safety information which should accompany certain restricted, implantable device promotions yet rarely if ever does. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 31 ligent and accurate viewing or decision about the device in the absence of specific hospital and surgeon/surgical group morbidity and mortality data. This is precisely the type of data which is rarely, if ever, provided during restricted, implantable medical device advertisements.148 The device and the device ad cannot be divorced from the learned intermediary in general, and in particular the one promoting it. This is simply not the case with promotions for prescription drugs, where the drug side effects are largely independent of the physician prescribing. There are other critical differences between DTCA of prescription drugs and restricted medical devices on the issue of safety and learned intermediaries. Surveys indicate that most internists do not believe that the majority of DTCA advertise- ments for drugs are misleading; the same cannot be said for surgeons.149 Medical devices fail, and need to be replaced, in a manner which does not apply to drugs. Even if this event were completely independent of the institution where the sur- gery was performed as well as the surgeon (which is not the case), this is another bit of critical information a consumer viewing a DTCA would need to have for the promotion to be both educational and balanced on risks. Yet this information never appears in advertisements for restricted, implantable medical devices such as coronary artery stents or artificial joint replacements. Lastly, the differences in the ways devices are approved compared to drugs touch directly on the issue of safety. Medical device trials can be based on bench data, data for a predicate device which may be several generations earlier and several degrees of separation in similarity, or based on a predicate device which need not be the best device in that class. Admit- tedly, this is not an issue for the most cutting-edge Class III restricted, implantable medical devices without a predicate device and approved via a PMA, but it is a viable issue and concern for some. Consumers are unaware and uninformed about these critical safety data concerns as well. D. FDA Enforcement Options Are Limited for DTCA of Restricted Medical Devices. The Office of Compliance at CDRH is the department responsible for monitor- ing advertising and promotion of medical devices by manufacturers to ensure that the information is not false or misleading. The tools available to FDA to enforce statutory rules and guidelines for DTCA of restricted medical devices against manu- facturers are limited and, from a practical point of view, of relatively little value. Between the warning letter and the injunction there is no effective intermediate mechanism (such as the ability to impose a civil monetary penalty on infractions) that will have any meaningful chance of rapidly impacting the sponsor’s advertising cycle in a significant way. Absent a demonstrable risk to public safety, it is virtu- ally impossible for FDA to take severe disciplinary action against a medical device manufacturer. The end result of this paucity of remedies against false advertising effectively limits FDA to only issuing warning letters to the manufacturers. There is no evidence that FDA’s meeting with a sponsor, the only other enforcement tool FDA uses, has any real value. Warning letters are simply that: a warning, and one which may be ignored temporarily while the false or misleading advertisement cycle continues to run. In the recent (September 2008) Congressional hearings on restricted medical device DTC advertising, the only speaker who specifically stated that the current enforcement system was perfectly adequate was Mr. Stephen Ubl, the representa- 148 Bozic, supra note 142. 149 Id. 32 Food and Drug Law Journal Vol. 64 tive from Advanced Medical Technology Association (AdvaMed), an association which represents over 1,600 manufacturers of medical devices.150 Ironically, Mr. Ubl’s comment151 that there was a relatively short 18-24 month lifecycle of some innovative, restricted medical device products compared to that for pharmaceuti- cals only served to magnify the significance of any delay on FDA’s part in sending warning letters to manufacturers about their DTCA campaigns. Follow-up comments152 at the same Congressional hearing by Daniel Schulz, MD, Director of CDRH, failed to specifically address whether current enforcement tools available to FDA were adequate despite the fact that that very issue was one of the topics the conference was supposed to address. Dr. Schulz instead focused almost exclusively on FDA surveillance and enforcement activities relating to promotion of off-label uses of medical devices to physicians. No specific comments were made on the level of enforcement activity in the area of DTCA either. FDA does not regulate the practice of medicine, nor does it regulate hospital ad- vertising practice. FDA’s ability to regulate surrogate advertising and promotion of restricted medical devices by hospitals, physicians or surgical groups and academic medical centers/ cancer centers is nonexistent. As noted in section V, regulation of physician advertising is regulated by individual state regulations, administered through the oversight of the individual state medical board. State laws on physi- cian advertising vary from state to state, and for this reason there is no guaranteed, uniform approach to surrogate DTCA of restricted medical devices by physicians. No formal administrative bridge exists between FDA and state medical boards to address this problem. VI. RECENT PUBLIC HEARINGS BY FDA ON DTCA OF RESTRICTED MEDICAL DEVICES All of the discussion thus far on the significant differences between restricted medical device and prescription drug DTC advertising strongly suggests that the current regulatory approach by FDA on DTC advertising and promotion of re- stricted, implantable medical devices is not adequate. FDA has been aware of the controversy surrounding DTC advertising of its approved medical products for more than a decade, particularly since the bruising legal battles with the Washing- ton Legal Foundation,153 although virtually all of the controversy, until recently, has concerned DTCA of prescription and over-the-counter drug products. This may now be changing. The most recent FDA activity on DTCA relating to restricted medical devices was a “Public Hearing on Direct-to-Consumer Promotion of Medical Products” 150 Statement by Stephen J. Ubl, President & CEO, AdvaMed at Marketing or Medicine: Are Di- rect-to-Consumer Medical Device Ads Playing Doctor?: Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail. cfm?id=303085 (last accessed Sept. 30, 2008).[hereafter Ubl statement]. 151 Id. “A Federal requirement for a moratorium for DTC advertising of medical devices would ignore the unique nature of our industry. Most medical devices have a lifecycle of 18 to 24 months and many of our industry’s technologies are new devices that provide relief for patients who suffer from conditions that currently have no treatment.” The latter statement cannot be correct if most of these devices reach market via 510(k) clearance since this means that a predicate device must already be on the market. 152 Schultz statement, supra note 55. 153 Washington Legal Foundation v. Henney, 128 F.Supp. 2d 11 (D.D.C. (2000)). “… after six years; worth of briefs, motions, opinions, Congressional acts, and more opinions, the issue remains 100 percent unresolved, and the country’s drug manufacturers are still without clear guidance as to their permissible conduct.” 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 33 held in Washington, D.C. on November 1, 2005.154 A wide range of experts from government, academia and industry met for two days to present their data, help FDA formulate policy, and discuss a series of questions FDA posed to the panel- ists. The six questions were: 1) Does current DTC promotion present the benefits and risks of using medical products in an accurate, non-misleading, balanced and understandable way? 2) Could changes in certain required prescription drug disclosures—the package insert for print “promotional” labeling and the brief summary for print advertisements—improve the usefulness of the information for consumers?; 3) Could changes in the requirements for disclosure of certain information in broadcast advertising improve the usefulness of this information for consumers?; 4) As new communication technologies emerge, they create oppor- tunities for novel approaches to DTC promotion. What issues should the agency consider with regard to the effect of these technologies on DTC promotion?; 5) What action should FDA take when companies disseminate violative promotional materials to consumers?; and 6) Does current DTC promotion present the benefits and risks of using medical products in an accurate, non-misleading, balanced and understandable way? It is important to note that the questions FDA posed to the panelists and speakers referred collectively to “medical products,” inherently lump- ing drugs and devices together as if the answers for one (drugs) would naturally apply to the other (devices). The 2005 conference had 38 presentations of which 20 were slide presentations. Of these 20 only one—by Marlene K. Tandy, a Senior Counsel at Johnson & John- son—was specifically asked about DTCA of medical devices.155 Of the 442 slides presented at the Public Hearing on DTCA of medical products, only six were spe- cifically on DTCA of restricted medical devices. Everything else concerned DTCA of prescription drugs, as were virtually all of the policy recommendations of all of the speakers. With the exception of the Tandy presentation, not one of the other speakers addressed any of the six fundamental questions posited by FDA at the start of the conference specifically in terms of DTCA of restricted medical devices. In addressing the six questions specifically in the context of restricted medical devices, Ms. Tandy stated that in her opinion, existing statutory requirements were sufficient for DTCA advertisements to communicate to consumers the ap- propriate, relevant information for the device being advertised, device-specific advertisements did disclose adequate and relevant safety information and exist- ing FDA enforcement action is sufficient and legal authority adequate.156 Given her position as a representative of the major trade organization that represented medical device manufacturers’ advertising interests, this statement was no surprise. Nor was it surprising that no substantive data was provided to support either of her contentions;157 there is in fact no current substantive data to support any of industry’s contentions on the adequacy or comprehensibility of DTC advertise- ments for restricted medical devices. Also not surprisingly, Ms. Tandy noted that pre-review of DTC advertisements by FDA should be an option, not mandatory, though acknowledging that there was a need for FDA guidance to address the issue of presenting technical information in language which was consumer-friendly.158 She also correctly pointed out that CDRH would need a substantial increase in personnel, as well as a new system in place, if it were going to attempt to review 154 Public Hearing on DTC Promotion of Medical Products, Wash., DC, (Nov. 1-2, 2005). 155 Marlene K. Tandy, MD, JD, Co-Chair, AdvaMed Advertising and Promotion Working Group, Senior Counsel, Johnson & Johnson, Presentation at FDA Public Hearing on Consumer-Directed Promotion of Regulated Medical Products, (Nov. 1, 2005). [hereafter Tandy statement]. 156 Id. 157 Id. 158 Id. 34 Food and Drug Law Journal Vol. 64 DTC advertisements prior to either restricted medical device approval or at the time of publication or broadcast.159 Insofar as DTCA of restricted medical devices is concerned, the question FDA did not ask at this conference, should have asked and should now be asking is whether the answers to the six questions it posed at the 2005 conference are the same for restricted medical devices as they are for prescription drugs. The answer, based on the data and concerns discussed in this paper, is no. The baseline fund of knowledge an adult consumer would be required to have to correctly comprehend a 30-60 second television ad for a restricted medical device such as a coronary ar- tery stent is greater than the amount needed to for that of a drug to treat the same condition, and in all likelihood is beyond most viewers.160 The limited amount of time allotted to these expensive ads, the complicated nature of both the medical condition being treated and its technological “fix,” and the absence of critical safety information on and for learned intermediaries essentially eliminates the ability to present necessary risk and benefit ratio in either a meaningful or fairly balanced way. There are no data thus far which suggest that manufacturers of restricted, implanted medical devices are presenting risk data in a balanced way, if data are provided in advertisements at all. On the physician side the individual possessing this expertise might not even be the consumer’s primary care physician but rather a physician to whom the patient’s primary source of medical information would refer him/her; primary care physicians also lack an organized guide of restricted medical device approved labels to consult for patients on appropriate risks and indications for the device, as they do for prescription drugs. VII. RECENT CONGRESSIONAL AWARENESS OF THE POTENTIAL PROBLEM OF DTCA FOR SOME RESTRICTED, IMPLANTED MEDICAL DEVICES IS AN ENCOURAGING DEVELOPMENT A. Congress is clearly concerned that DTCA for restricted medical devices is inherently less educational, more promotional, poten- tially more misleading and subject to less oversight by FDA than DTCA is for drugs. DTC advertising of medical devices made the official Congressional radar screen in September, 2008 in a hearing before the Senate Special Committee on Aging161 convened by Senators Herb Kohl (D-WI) and Gordon H. Smith (R-OR) as part of an on-going 15-month series of oversight hearings on medical device and pharmaceutical marketing. The purpose of the committee meeting was to hear testimony from representatives from the medical device industry, physician-surgeons with expertise in medical device advertising, consumer groups, advertising groups, CDRH/FDA representatives, as well as academics with extensive clinical research 159 Id. 160 Most of these restricted medical device ads for implanted medical devices would be incompre- hensible to most Americans if they really did attempt to discuss safety in a meaningful way; studies have shown that the American public, on average, reads at an eighth grade level. See Kunter Greenberg, M., Jin Y., E., et.al., Literacy in Everyday Life: Results from the 2003 National Assessment of Adult Literacy, (Apr. 2007). United States Department of Education, NCES 2007-480. 161 Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?: Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www. aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 35 experience in consumer comprehension of medical product advertisements in or- der to determine whether appropriate risk and safety information about restricted medical devices is being provided to consumers, particularly the elderly. The Special Committee appeared acutely aware of the fact that direct to con- sumer advertising of restricted medical devices, particularly restricted implanted devices such as coronary artery stents and artificial knees, is a growing but recent phenomenon and one which had yet to be highly scrutinized.162 With the exception of testimony from the representative of the medical device advertising industry,163 virtually all of the speakers emphasized the glaring deficiencies in safety risk infor- mation, and comprehension of such information, for consumers viewing DTCA of restricted, particularly implanted, medical devices. The testimony confirmed the general impression of most surgeons that most patients do not understand the safety risk information they view or are able to determine whether they are suit- able candidates for the device.164 One of the physicians who testified was the first speaker to point out in a Congressional hearing the entrepreneurial relationship physicians are more likely to have with medical device manufacturers compared to pharmaceutical companies, and the role of medical device technology in hospital and surgical group marketing efforts.165 The Senate hearing reviewed the television ad campaign for Johnson & John- son/Cordis’s Cypher sirolimus-eluting stent and replayed the television ad in its entirety. Despite the comment by an aide to Senator Kohl that the advertisement was reviewed and okayed after edits by CDRH before its release166 (and a conspicuous absence of comment on this point by CDRH Head Daniel Schultz, MD), William E. Boden, chief of cardiology at Buffalo General Hospital, was highly critical of the device advertisement, noting that it had “crossed the line” because “the decision to employ a coronary artery stent required “a very sophisticated medical understanding” which few, if any, members of the lay public would have before or after viewing such an advertisement.167 Some of the Congressional testimony on DTCA of restricted medical devices was predictable and some disappointing. The testimony168 by Stephen J. Ubl, President and CEO of the trade association which represents the advertising in- terests of many medical device manufacturers predictably advocated no change in the current way DTCA of restricted implantable medical devices is regulated by FDA, while at the same time listing some of the ways these medical devices were different and more complicated than pharmaceuticals. Mr. Ubl repetitively stated the mantra that advertisements to consumers are educational, yet provided no data to demonstrate that this is so for such devices, while at the same time pointed out how much more complicated devices and their requisite surgery are than pharma- ceuticals (“the idea that a patient would decide to undergo complex and invasive procedures based on an advertisement, or that a physician would agree to perform 162 Opening Statement of Senator Herb Kohl, Special Committee on Aging Hearing, Marketing or Medicine: Are DTC Medical Device Advertisements Playing Doctor?, (Sept. 17, 2008). 163 Ubl statement, supra note 150. 164 Bozic statement, supra note 142. 165 Id. 166 [THE GRAY SHEET], Senate Explores Restrictions on Direct-To-Consumer Devices Ads, (Sept. 22, 2008), available at http://www.medicaldevicestoday.com/2008/09/senate-explores.html (last accessed Oct. 27, 2008). 167 Boden, supra note 28. 168 Ubl statement, supra note 150. 36 Food and Drug Law Journal Vol. 64 them, is difficult to imagine.”)169 All of this seemed inherently contradictory: if the surgery and the devices are so complex and difficult to understand, why attempt to promote them to consumers at all, given the well-known problems consumers already have with DTCA of drugs which are not so complicated? It would be one thing if the advertisements were only about specific conditions, such as arthritis, since a claim could then be made that the advertisement is educational, (i.e., it is a disease-awareness advertisement). But there is little controversy over disease aware- ness advertisements, FDA has no jurisdiction over such advertisements, and such advertisements do not increase market share for a device, which is why nearly all of the advertisements are device-specific.170 The testimony by Daniel Schultz, Director of CDRH, was remarkable for what it did not say.171 Dr. Schultz provided an overview of basic medical device regulation- classification of devices, how devices become restricted, the two draft guidance FDA issued on restricted medical device advertising and promotion, and reviewed some, but not all, of the differences between regulation of drugs and restricted medical devices by FDA. All of the comments on enforcement, however, concerned adver- tising and promotion of restricted medical devices by manufacturers to physicians, not consumers, and the examples cited concerned off-label use of biliary stents, not on-label use of coronary artery stents. More importantly, no recommendations for reforming FDA’s current approach, or any possible limitations on protecting consumers from false or misleading restricted medical device advertising due to FDA’s current lack of specific guidance and lack of premarketing advertisement evaluation were noted.172 The Senate hearings occurred during the same month that Senator Charles Grassley (R-IA) was continuing his probe173 into the business relationship between the medical device maker Medtronic and multiple orthopedic surgical groups which used their spinal surgery devices. Allegations of kickbacks and financial and other incentives between Medtronic and unnamed surgical groups over promotion of use of spinal devices and off-label use of Medtronic bone grafts formed the basis of several qui tam lawsuits by former employees of Medtronic. One of these suits resulted in a $40 million private settlement agreement between the federal government and Medtron- ic.174 Medtronic now claims that since 2004 it has overhauled its code of conduct for relations with surgeons who use its products, though Senate hearings are ongoing to determine if corporate and physician misconduct has persisted. 169 Id. 170 Id. The statement by Mr. Ubl touted the potential educational benefits of device advertise- ments yet provided no data. The data that was provided at the Congressional hearing by the orthopedic surgeon and the interventional cardiologist strongly indicated that consumers do not derive some of the educational benefits, which is not only making one aware of a condition but whether one is actually an appropriate candidate for the treatment or has awareness of the risks. Mr. Ubl’s discounting of the notion that a patient might decide to undergo a complex and invasive procedure based on an advertisement or that a physician might agree to perform a surgery using a device he is reimbursed for at a higher rate merely suggests that he does not get out much. The U.S. Department of Justice has been investigating financial incentives to orthopedic surgeons for years, and the data on patient demand for prescription medications and genetic testing indicates that advertising drives demand, particularly for complicated medications such as cancer chemotherapy and BRCA-screening for cancer predisposition. 171 Schultz statement, supra note 55. 172 Id. 173 Armstrong, David, Lawsuit Says Medtronic Gave Doctors Array of Perks, THE WALL STREET JOURNAL, (Sept. 25, 2008), at B1. 174 Id. 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 37 B. Recent Proposed Legislation The recent Congressional hearings on the problem of DTCA of restricted medi- cal devices is not the only evidence indicating that Congressional attention has now focused on this issue. Within the past three years, two separate bills were introduced in the House of Representatives to address problems in DTC advertising. The first, H.R. 3696,175 was introduced as the “Medical Advertising Reform Act” on Sep- tember 8, 2005 and referred to the House Committee on Energy and Commerce, from which is was referred to the Subcommittee on Health. Although this bill never made it out of Committee, it contained five interesting provisions. The bill would have 1) instituted a two-year moratorium on DTC advertising of newly approved prescription drugs, 2) required prior approval of content for an advertisement for a restricted medical device, 3) authorized a study by the Government Accountability Office (GAO) on the impact of consumer-directed advertising on restricted medi- cal device utilization and spending for the purpose of evaluating whether current regulatory controls are adequate to ensure that DTCA of restricted medical devices provides consumers with “complete and accurate information concerning the safety and effectiveness”176 of the device, 4) ensured that FDA had sufficient resources for the task of monitoring DTCA of restricted medical devices and undertaking appropriate enforcement action and 5) required that the GAO report be submitted to the House Committee no later than July 1, 2006.177 Although H.R. 3696 apparently died in Committee, another bill on restricted medical device advertising was introduced by Representative Rosa DeLauro (D-CT) on May 22, 2008.178 H.R. 6151, entitled the “Responsibility in Drug and Device Advertising Act of 2008,” is currently now in the House Committee on Energy and Commerce. H.R. 6151 proposes to amend the 1938 FDCA by prohibiting DTC advertising for three years from FDA approval of either a new prescription drug or “a Class II or Class III device for which a premarket notification is submitted under section 510(k) or a Class III device for which a premarket approval is sought under section 515;”179 the prohibition could be extended if advertisements were not fairly balanced. In addition to proposing a longer moratorium than H.R. 3696 did, the bill now in Committee proposed that §303(g) of the FDCA180 be amended so that manufacturers who violate any section of the Act which deals with advertising of a drug or device could be subject to civil penalties of up to $1,000,000 for first violations and up to twice this amount for subsequent violations. The fate of this newest bill remains to be seen. VIII. ADDRESSING THE PROBLEMS OF DTCA OF RESTRICTED, IMPLANTED MEDICAL DEVICES For the past decade almost every major law review article, food and drug law casebook, significant litigation controversy, and conference on advertising and promotion of medical products to consumers has invariably focused on direct 175 H.R. 3696, 109th Cong., (2005), Medical Advertising Reform Act. 176 Id. 177 Id. 178 H.R. 6151, 110th Cong. (2008), “Responsibility in Drug and Device Advertising Act of 2008.” 179 Id. 180 21 U.S.C. 333. 38 Food and Drug Law Journal Vol. 64 to consumer advertising of drugs. The end result of all of this is a relative gap in scholarly writing, and analysis, of the issue of direct to consumer advertising of restricted medical devices. The implicit assumption has been that because advertis- ing and promotion of prescription drugs and restricted medical devices are both regulated by FDA, the advertising and promotion issues are similar and can be regulated in similar manner. This might be the case if the advertising of prescrip- tion drugs and restricted medical devices by the manufacturers were conducted the same way, or if the safety information required were the same. As has been shown, neither of these is true The critical issue which must be resolved may be stated as follows: are the dif- ferences in advertisement content, consumer comprehension, FDA review, and learned intermediary involvement and danger of inadequacies in risk presentation for restricted, implantable medical devices so great that a different regulatory ap- proach to DTCA of such medical devices is needed? For all of the reasons discussed in this article, it is this author’s opinion that the regulation of the advertising and promotion of restricted devices which are surgically implanted requires differ- ent regulation, greater and more stringent safety information, and poses greater challenges for consumers to properly understand than that for prescription drugs. Absent a different regulatory approach to DTCA of restricted medical devices, consumers cannot be protected from misleading and inadequate promotions that could ultimately result in suboptimal healthcare decisions on their part. The role of the medical profession in medical device development, financial investment, and direct advertising and promotion is less arm’s length than it is for prescription drugs, and both state and federal regulators have yet to fully come to terms with this difference. The ability of companies to advertise and promote their most technologically advanced and potentially dangerous medical devices to consumers through marketing efforts by individual physician groups, hospitals, university/ academic medical centers and regional cancer centers allows sponsors to circumvent FDA regulation of their activities. Lastly, all of the safety data omis- sions in promotion for restricted implanted medical devices which are highlighted in the few clinical studies that have methodically examined DTCA of restricted, implanted medical devices for both consumer comprehension and safety informa- tion content have all shown alarming problems, and generally ignored the significant links of restricted medical device safety to hospital and physician performance in a way that simply does not apply to prescription drug DTCA. A “one size fits all” regulatory approach by FDA which addresses advertising and promotion of drugs and devices as if they can be treated the same way simply will not work. Much can be and should be done to rectify this situation. A. What FDA Should Do FDA should conduct a greater level of oversight of DTC advertisements for restricted, implantable medical devices than the agency is now doing and be given the financial and personnel resources to do this. Review of all printed and broadcast advertisements for restricted, surgically implanted Class III medical devices should be the rule, not the exception. There are fewer enforcement actions against medical device manufacturers over DTCA because FDA pays less attention to the issue and, in an era of financial, legal and personnel resources stretched thin due to the nature of its work and the 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 39 continually increasing administrative burden placed on it by Congress, FDA may not be able to adequately police the medical device industry because it cannot. The recently enacted FDAAA contained a section which included greater authorization for FDA to require pre-review of DTC advertisements to ensure that consumers are adequately informed of safety risks; this authority should now be exercised. Further amendment of the FDCA may be necessary to empower FDA to adequately police DTCA of restricted, implanted medical devices. Even with its relatively limited resources, there are other things FDA can and should do now that do not require amending the FDCA. FDA should issue a separate guidance document for DTCA of medical devices for print advertisements similar to the Brief Summary: Disclosing Risk Information in Consumer-Directed Print Ad- vertisements which was issued as a Draft Guidance by FDA in January 2004. This new document should describe the type of safety information which would need to be included in any printed advertisement for restricted medical devices. This risk information would have to disclose the fact that the primary care doctor might not be the most knowledgeable person to talk to about the surgical aspects and potential complications of some of these devices. More importantly, this document should also state that the required safety information provided to consumers for any implantable medical device such as knee, hip, heart valves and coronary artery stents in an adver- tisement in any medium should be required to have a core of safety information on the real possibility of infections and complications from implantation, the expected life span of the device before replacement is required, information relating to the surgical aspects of implanting the device, and a statement that any advertisement for an implanted, restricted medical device by a surgeon, surgical group or academic medical center must present appropriate and necessary safety information such as complication rates in a comprehensible manner. FDA should remove the current loophole for broadcast advertisements which allows a stronger standard (the brief summary) to exist for printed media advertise- ments than for broadcast advertisements on radio and television. Instead of the brief summary for these advertisements, device manufacturers are allowed to only make adequate provision for dissemination of the approved package labeling in conjunction with the advertisement.181 There is no reason why the same informa- tion, and same standard, should not apply equally to printed and broadcast media for complex restricted medical devices; a new guidance document should reflect this position. One consequence of this approach might be that if both printed and broadcast advertisements for restricted, implanted medical devices have the same standard for safety information content, there may not be broadcast advertise- ments for some medical devices if a way cannot be found to convey the full brief summary for these devices in a manner easily understood by the average consumer. The guidance approach, rather than a proposed rule, is consistent with FDA’s recent preferred approach of issuing documents which reflect its current thinking on a controversial subject without it being binding on industry.182 This route would 181 Ruskin statement, supra note 89. 182 Rakoff, Todd D., The Choice Between Formal and Informal Modes of Administrative Regulation, 52 ADMIN. LAW REV. 159 (2000). “If we compare the mid-1990s with the late 1970s or early 1980s we find that the number of FDA regulations adopted each year in accordance with the APA’s rulemaking procedures declined by about fifty percent. By contrast, since the start of this decade [the 1990s] there has been a striking increase in the number of FDA-issued documents intended to give guidance to the regulated industry but not adopted through public procedures.” Although the Guidance documents are statements of no legal consequence they are of enormous practical consequence since industry can conform its conduct to current agency thinking and expedite the medical product marketing review process. 40 Food and Drug Law Journal Vol. 64 also allow FDA to get feedback from industry and to also undertake or contract for much-needed additional study of consumer understanding of information in restricted medical device advertisements. This behavioral data183 could be used to ultimately ground the basis of a proposed rule it could publish and entertain formal notice and comment on. FDA should also require pre-broadcast advertisement submission and clearance for television promotion of restricted medical devices at the time of approval, rather than publication/broadcast, to avoid repeating the scenario which accompanied the aftermath of the Cypher cardiac stent television advertisement. This may require more personnel and administrative resources than CDRH currently has, and if so, will require attention by Congress to correct this. FDA should also end its policy of Chief Counsel’s Office review and approval of all enforcement letters.184 Ultimately, the determination that a restricted medical device advertisement is false or misleading is a medical decision based on evaluation of clinical information, not a legal one (for example, DDMAC already has medical personnel and attorneys in the division and is capable of conducting this activity independently). Present policy, as constructed, amounts to little more than a gift to sponsors which ensures that fewer warning letters will go out and when they do they will be sent after such a long delay that the misleading or false advertising will have already accomplished the bulk of its marketing objectives. One final action which FDA should undertake is to call for a two-year morato- rium on DTC advertising of restricted medical devices which are implanted into the human body. In so doing, FDA would simply be acknowledging that all of the available data on the safety content and consumer comprehension of these adver- tisements demonstrates that they are typically misleading and non-educational. The American Medical Association (AMA) called for a moratorium on DTCA of new prescription drugs and implantable medical devices in 2006;185 it is now time to heed this call. The moratorium would allow more data and formal study on ap- propriate content, safety and consumer comprehension to be undertaken, with an eye towards revision of Guidance documents and rules for DTCA of such devices. As of this writing AdvaMed has not advocated adoption of voluntary restraint for restricted, implanted medical device advertisements in the same way PhRMA has for new prescription drugs. B. What Other Parties Should Do Medical societies such as the AMA should renew their calls for a moratorium as well as insist on full financial disclosure by physicians, surgeons and hospitals of all potential conflicts of interest for use of restricted medical devices they are either developing or promoting. State medical boards should also take aggressive action against physicians who engage in fraudulent or misleading promotion of medical 183 Harold, Rosemary C. & Kamp, John F., Grounding Regulation in Behavioral Science: Strength- ening FDA’s Approach to DTC Risk Disclosures, FDLI UPDATE MAGAZINE, (Nov./Dec. 2004). 184 GAO, Report to Congressional Requesters, Prescription Drugs. Trends in FDA’s Oversight of Direct-to-Consumer Advertising, (MAY 8, 2008), available at http://www.gao.gov/new.items/03177.pdf (last accessed Oct. 27, 2008). The basic conclusion of the GAO Report was that FDA bureaucracy gummed up DTC ad reviews, with the result that there was no longer an effective system to track and prioritize review of DTC advertisements, with the result that the gap between violative advertisements and the issuance of regulatory letters had widened considerably. In addition, the Assistant Director of DDMAC at CDER is an attorney and specialist in food and drug law; involvement of more attorneys in the Chief Counsel’s Office would appear to add little value to the review DTCA review process. 185 AMA, Position Statement, Direct-to-Consumer Advertising 2007, available at http://www.ama. com.au/web.nsf/doc/ween-7am7ch (last accessed Oct. 16, 2008). 2009 DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES 41 devices they use or when physicians fail to disclose potential conflicts of interest they have. The Department of Justice should continue its investigations into the financial incentive relationships between restricted medical device manufacturers and physician surgical specialty groups.186 Congress should pass legislation which would give FDA power to impose civil monetary penalties on medical device manufacturers who promote restricted devices in a fraudulent, false or misleading manner. Lastly, Congress should authorize the GAO to formally study the effect of DTCA of restricted medical devices on consumer behavior, and incorporate those findings into any legislation amending the FDCA which Congress passes to specifically address problems with DTCA of restricted medical devices. IX. CONCLUSION There are significant differences between the methods and implications of re- stricted, implantable medical device advertising and promotion when compared to prescription drugs. These differences include greater direct involvement by the medical profession, a closer relationship to the development of medical device tech- nologies for learned intermediaries, dramatic differences in consumer knowledge and comprehension and routine omission of critical safety information consumers need to make educated decisions. For all of these reasons the advertising and promotion of such medical devices to consumers merits separate consideration, and requires different regulatory and guidance standards, than that for prescription drugs. FDA and Congressional action specifically directed to assert more control of the grow- ing problem of DTCA of implantable, restricted medical devices is overdue, and if done in a timely manner could prevent some of the problems endemic to DTCA for pharmaceuticals from becoming part of the culture of DTCA of restricted, implanted medical devices. The medical device industry will likely continue to advertise restricted implant- able medical devices directly to consumers now that the “barrier” has been broken, and will do so in a progressively more aggressive manner until there is regulatory “push back” by FDA and Congress considers, or passes, legislation. A moratorium on DTCA of implantable, restricted medical devices for two years should provide a much needed opportunity to generate clinical and consumer behavioral data. This should allow both sides to contribute to any revamping of the regulatory approach of DTCA, permit manufacturers to exercise their First Amendment rights while maximizing meaningful and adequate consumer health information and allow FDA to fulfill its mission. 186 Rhea, Shawn, Medtronic reveals investigation, MODERN HEALTHCARE, (Dec. 10, 2007).
Pages to are hidden for
"patsner_fdlj_lasik-warnings _08-34_"Please download to view full document