Direct-to-Consumer Broadcast Adv

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Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or Manipulating a Vulnerable Population? KELLY N. REEVES *
I. INTRODUCTION
A hot-air balloon floats lazily across the backdrop of a beautiful, cloudless, sunny sky.1 Cole Porter sings in the background, “Blue skies smiling at me Nothing but blue skies do I see.”2 A kind voice instructs the viewer to “see your doctor about Claritin®” because a “clear answer is out there.”3 This advertisement for Claritin®, a nondrowsy prescription antihistamine, aired prior to the Food and Drug Administration’s (FDA’s) release of new direct-to-consumer (DTC) broadcast advertising guidelines in August 1997.4 The viewer often was bewildered because the “clear answer” about what Claritin® treated was not in the otherwise well-produced thirty-second television advertisement.5 The Claritin® commercial was a “reminder advertisement,” one of the few prescription drug advertising methods exempted from FDA’s “brief summary” requirement.6 Because reminder advertisements do not reveal information about the effectiveness of the drug, these advertisements leave viewers wondering what the advertised prescription drug is intended to treat.7 FDA recognized that the prescription drug advertising regulations impeded the flow of product information to consumers, and issued new guidance to clarify the requirements and alleviate the restrictions on broadcast advertisements.8 In the revised Claritin® advertisement, the announcer informs viewers that they can “escape sneezing, runny nose, itchy eyes” and “only [Claritin®] one tablet means 24-hour non-drowsy seasonal relief.”9 Since FDA issued the Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements, prescription drug commercials have flooded television networks.10
* Ms. Reeves is a third-year law student at the University of Maryland School of Law. A previous version of this article won second place in the 1997-1998 H. Thomas Austern Memorial Writing Competition sponsored by FDLI. 1 See All Things Considered: Concern Over Drug Ads (Nat’l Pub. Radio broadcast, Mar. 18, 1998) (audio clip Claritin® television commercial) [hereinafter Concern Over Drug Ads]. 2 See id. 3 See id. 4 See Announcing Availability of Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements, 62 Fed. Reg. 43,171, 43,172 (Aug. 12, 1997). 5 See Concern Over Drug Ads, supra note 1. 6 21 C.F.R. § 202.1(e)(2)(i) (1997). See infra notes 31-34, 59-64 and accompanying text. 7 See All Things Considered: FDA Media Rules Change (Nat’l Pub. Radio broadcast, Aug. 9, 1997) [hereinafter Media Rules Change]; Tamara Nordenberg, Direct to You: TV Ads That Make Sense, FDA CONSUMER, Jan.-Feb. 1998, at 7. 8 See 62 Fed. Reg. at 43,172. It took more than a decade of considerable consumer group and industry pressure for the agency to begin shaping a policy on direct-to-consumer (DTC) prescription drug advertising. See infra notes 67-121 and accompanying text. The draft guidelines clarifying the “adequate provision” requirement are anticipated to begin this policy formation. See Direct-to-Consumer Promotion Public Hearing Announced, 60 Fed. Reg. 42,581 (Aug. 15, 1995). 9 See Concern Over Drug Ads, supra note 1. 10 See 62 Fed. Reg. at 43,171; Guidance for Industry: Consumer-Directed Broadcast Advertisements (Draft Guidance), Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA (July 1997) [hereinafter Draft Guidance]; Michael Wilke, Pharmaceutical Companies and the Food & Drug Administration Face Great Challenges as They Work on Designing a Marketing Map for the Flourishing Prescription Drug Universe: Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 1, available in 1998 WL 6629326.

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The pharmaceutical industry spent a record $1 billion on DTC advertising in 1997.11 Under FDA’s new policy, media specialists predict DTC spending will reach $2 billion in 1998, with broadcast spending expected to constitute half that amount.12 Until 1997, prescription drug advertising on television accounted for only ten percent of DTC spending on prescription drug advertising.13 Advertising executives on Madison Avenue surely are salivating at the millions to be made in a prescription drug marketing bonanza under the relaxed conditions, as pharmaceutical companies vie for market share for prescription drugs in competitive, overpopulated therapeutic classes.14 But where does the new policy leave the public, whom the FDA is charged with protecting? Ideally, increased access to information leads to a more informed public and an expanded public health dialogue about prescription drug therapy.15 After viewing a drug commercial, patients will be able to discuss available treatments more knowledgeably with their doctors.16 In the age of managed care and restrictive drug formularies, consumers need to be armed with information about available drug therapy to ensure that their own health needs are being met.17 Even if new DTC prescription drug advertisements do not meet all consumer healthcare information needs, at least the television commercials now will feature the indication of the drug as well as the trade name, and will ensure, through the “adequate provision” requirement, that consumers will have the opportunity to get more product information.18 FDA must perfect its new policy, which was issued in draft form.19 FDA may revise the policy before issuing its final guidance, expected in February 1999.20 After the final guidance is issued, FDA intends to re-evaluate the effect of its new policy on public health,21 and within two years of that publication, FDA will determine whether the guidance will be “withdrawn, continued, or modified to reflect the Agency’s current thinking.”22
11 See Carl T. Hall, Drug Ads Boost Profits, But Consumers May Feel Pinch, S.F. CHRON., Mar. 12, 1998, at E1 (citing estimates by The Plymouth Group). The majority of spending results from the surge of advertisements after the Draft Guidance was issued. See also Wilke, supra note 10, at 1 (quoting similar estimates of DTC broadcast advertising spending); Greg Borzo, New FDA Rules for Advertising Drugs on TV Raise Questions, AM. MED. NEWS, Sept. 8, 1997, at 5-6, available in 1997 WL 9149598. DTC advertising appears to be working; more than three-quarters of physicians surveyed in 1996 said that their patients ask for drugs they see advertised. See Nordenberg, supra note 7, at 8 (citing 1996 study by Scott-Levin Associates, named Direct-toConsumer Advertising). 12 See Steals & Deals: Few Pharmaceutical Companies Take Advantage of New FDA Rule Allowing for Changes in Prescription Drug Advertisements (CNBC radio broadcast, Sept. 4, 1997) (quoting Kal Leibowitz, President, KSL Media); see also Borzo, supra note 11, at 3 (“DTC broadcast spending is expected to be 15% to 20% over what was already projected for the coming year.”) (quoting Daniel L. Jaffe, Executive Vice President, Ass’n of Nat’l Advertisers). 13 See Borzo, supra note 11, at 3. 14 See Walt Sandulli et al., Winning Strategies in DTC, 32 MED. MKTG. & MEDIA 41, 42 (1997). But see Ivy Kazenhoff, Prescription for Profit: Balance Unsteady Between Creative Strict Compliance: Relationships, Ethnic Diversity Still Common Ad Themes, ADVER. AGE, Mar. 16, 1998, at 28, available in 1998 WL 6629316 (describing restrictions that regulations place on advertisement creativity). 15 See infra notes 99-105 and accompanying text. 16 Id. 17 Id. 18 See 62 Fed. Reg. at 43,172. See also infra notes 138-44 and accompanying text. 19 See Draft Guidance, supra note 10, at 43,171. 20 See Jack Volpi, Prescription for Profit: Research Is Still at a Premium for All Groups Seeking Answers, ADVER. AGE, Mar. 16, 1998, at 20, available in 1998 WL 6629324. In the interim, FDA is accepting information from external studies on the effectiveness of the proposed policy. See 62 Fed. Reg. at 43,171, 43,172. The final guidance is not legally binding on the agency and is subject to change as the agency’s “current thinking” on the topic changes. See id. See also infra notes 129-34 and accompanying text. 21 62 Fed. Reg. at 43,172. 22 Id.

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This paper discusses the evolution of FDA policy on DTC prescription drug promotion and recounts influential events in prescription drug advertising over the past fifteen years. The paper then reviews FDA’s new Draft Guidance on DTC broadcast advertising, examines the implications of the “adequate provision” requirement, and examine empirical evidence demonstrating the pharmaceutical industry’s utilization of DTC television advertising opportunities over the last eight months. The paper later speculates on further changes to the Draft Guidance after FDA has evaluated its impact. Finally, the paper comments on the public’s lack of prescription drug therapy information, its need for that information, and the ability of the pharmaceutical industry to fill that void with DTC broadcast advertising.

II. FDA REGULATIONS GOVERNING PRESCRIPTION DRUG ADVERTISING A. Regulatory Jurisdiction Over Prescription Drug Advertising
In 1962, Congress passed the Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA),23 transferring authority to regulate prescription drug advertising from the Federal Trade Commission (FTC) to FDA. Prescription drug advertising is addressed in one section of the FDCA.24 Section 502(n) of the FDCA requires prescription drug advertisements to comply only with a few provisions relating to appearance and content.25 FDA is charged with promulgating regulations governing the remaining elements of prescription drug advertising, including the only other enumerated requirement in section 502(n): the “brief summary” of information relating to the side effects, contraindications, and effectiveness of the drug that must appear in the advertisement.26 Section 502(n) does not distinguish between prescription drug advertisements directed at consumers or physicians, and has been interpreted to grant FDA authority to regulate all forms of prescription drug promotion, including direct-to-consumer advertising.27 FDA’s prescription drug advertising regulations also do not distinguish between advertising targeting physicians and that tar23 Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)). 24 21 U.S.C. § 352(n) (FDCA § 502(n)). 25 Id. § 352(n)(1)-(3). The typesize of the established drug name must be at least half as large as the typesize of the brand name and display the formula showing quantitatively each drug ingredient. Id. An advertisement not meeting the requirements set out in the FDCA or FDA regulations will be deemed misbranded and subject to FDA enforcement proceedings. Id. § 352(a) (FDCA § 502(a)). 26 Id. § 352(n)(3) (FDCA § 502(n)(3)). FDA promulgated regulations immediately after the amendments passed in 1963 and 1964, and later revised them in 1967, 1968, and 1969. See 28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963); 28 Fed. Reg. 9837 (Sept. 10, 1963); 28 Fed. Reg. 10,993 (Oct. 15, 1963); 29 Fed. Reg. 257 (Jan. 10, 1964); 32 Fed. Reg. 7533 (May 23, 1967); 33 Fed. Reg. 9393 (June 27, 1968); 34 Fed. Reg. 7802 (May 16, 1969) (codified in 21 C.F.R. § 202.1). 27 21 U.S.C. § 352(n) (FDCA § 502(n)). See generally 21 C.F.R. § 202.1 (regulations on prescription drug advertising); Withdrawal of Moratorium on Direct-to-Consumer Prescription Drug Advertising, 50 Fed. Reg. 36,677, 36,678 (1985) (“FDA will continue to regulate prescription drug advertising, regardless of its intended audience, in accordance with section 502(n) . . . and the implementing regulations (21 C.F.R. pt. 202)”). Ironically, the legislative history of the Kefauver-Harris Amendments reveals that Senator Kefauver was primarily concerned with prescription drug advertisements directed at physicians, not consumers. 108 CONG. REC. 17,369 (1962). We found cases concerning drugs that were addictive and in which nothing at all was said about side effects . . . that has been misleading to the physician. This proposal [advertisements must be accurate with respect to what it is said a drug will do and state the side effects and effectiveness] is a very important part of the bill. It will provide the physician with honest and useful information. Id. (statement of Sen. Estes Kefauver, cosponsor of the 1962 Amendments) (alteration in original; emphasis added).

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geting consumers.28 The prescription drug advertising regulations, however, do distinguish between print and broadcast advertisements.29

B. Overview of Current FDA Regulations Governing DTC Broadcast Advertisements 1. Important Regulatory Definitions
To frame the discussion on FDA’s new DTC broadcast advertising policy, four major terms found in the prescription drug advertising regulations must be defined: “brief summary,” “major statement,” “adequate provision,” and “fair balance.”30 The “brief summary” is a summary of information that is fully disclosed in the product labeling about the product’s side effects, contraindications, and effectiveness.31 Dosage and pharmacological information required in the product labeling is not required in the brief summary.32 The brief summary must accompany all prescription drug advertisements that discuss a drug’s indication for use or effectiveness. The brief summary requirement is the same for print and broadcast advertisements unless “adequate provision” is made for distribution of the approved product labeling.33 If adequate provision of product labeling is made, then the brief summary requirement for broadcast advertisements is reduced to communicating information only about the major side effects and contraindications of the drug in the audio or the audio and visual parts of the broadcast presentation.34 The “major statement” is the information about these major side effects and contraindications.35 The major statement does not require information about drug effectiveness, but only requires information about side effects and contraindications.36 The major statement may be limited to the side effects and contraindications that correspond to the indication for which the drug is advertised, to the extent that such limited disclosure has been approved or permitted in the drug labeling.37
28 21 C.F.R. § 202.1. This distinction between physician and consumer-targeted advertising is significant and has been the subject of FDA discussions because the information needs and sophistication level of patients and physicians are recognizably different. Information targeted to both populations, however, is governed by the same regulations, which do not recognize the different needs. See infra notes 88-95 and accompanying text. 29 21 C.F.R. § 202.1(l)(1). Advertisements in journals, brochures, and direct mail are regulated as print advertisements, and advertisements broadcast via television, radio, and telephone communication systems are regulated as broadcast advertisements. Id. See infra notes 31-42 and accompanying text. 30 21 C.F.R. § 202.1(e). 31 Id. § 202.1(e)(1). The brief summary must be a “true statement” of information; it can not be false or misleading; fail to present a fair balance of information relating to drug effectiveness and side effects; or fail to reveal material facts about the consequences of using the drug as recommended. Id. § 202.1(e)(5)(i)-(iii). See infra notes 47-51 for discussion of the “fair balance” requirement. Labeling is defined as “all other written, printed, or graphic matter upon any article or on of its containers or wrappers, or accompanying such article.” 21 U.S.C. § 321(m) (FDCA § 201(m)). 32 21 C.F.R. § 202.1(e)(1). 33 Id. Reminder, help-seeking, bulk-sale, and prescription-compounding drug advertisements are exempt from the brief summary requirements because they do not advertise the drug indication. Id. § 202.1(e)(2)(i)-(iii). See also infra notes 59-62 and accompanying text. 34 21 C.F.R. § 202.1(e)(1). 35 Id. 36 Id. 37 Id. § 202.1(e)(3)(iii)(a). An advertiser also may use a single term for a group of side effects and contraindications, but only if the use of that single term is permitted or approved in the drug labeling. Id. § 202.1(e)(3)(iii)(b). The major statement regulation has been criticized as being ill-defined and misguiding to consumers because it only requires the most common side effects to be revealed, omitting uncommon side effects, which are often the most disturbing. See Wilke, supra note 10, at 2; Borzo, supra note 11, at 4.

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Current regulations do not define adequate provision of approved product labeling, and prior to the publication of the Draft Guidance, FDA had never publicly interpreted its adequate provision requirement.38 Because of the ambiguity of the adequate provision requirement prior to the Draft Guidance, drug manufacturers primarily produced only reminder or help-seeking advertisements.39 The full brief summary requirement, which is easily satisfied in print advertising, is too burdensome for a thirty-second television commercial.40 Instead, manufacturers produced broadcast advertisements like the ambiguous “Blue Skies” Claritin® commercial, the reminder advertisement discussed in the introduction, that left consumers bewildered.41 Prescription drug advertising regulations list thirty-three ways in which an advertisement may be false or misleading.42 For example, an advertisement may be false or misleading when it advertises unapproved uses,43 makes comparative claims,44 or misrepresents data from studies.45 An advertisement also may be misleading if it fails to present a “fair balance” of information relating to a drug’s side effects and effectiveness.46 The fair balance requirement applies to the content of the materials and the format or manner in which risk information is presented.47 An advertisement does not present a fair balance if risk information is de-emphasized or obscured.48 To determine whether the risk information is de-emphasized or obscured, the agency com38 See 62 Fed. Reg. at 43,171; see infra notes 67-121 and accompanying text for the history of DTC regulatory policy prior to the Draft Guidance publication. 39 See Nordenberg, supra note 7, at 7; see infra notes 59-62 for discussion of reminder and help-seeking advertisements. 40 See Nordenberg, supra note 7, at 7. 41 See supra notes 1-3 and accompanying text. 42 See 21 C.F.R. § 202.1(e)(5)-(7). 43 Id. § 202.1(e)(6)(i). See, e.g., Letter from Minnie Baylor-Henry, Director, DDMAC, FDA, to Patrick J. Zenner, President & CEO, Hoffmann-La Roche, Inc. (Roche) (Mar. 5, 1998) (warning letter to Roche for promotion of Accutane® for an unapproved use) (on file with FDA). Roche . . . has not systematically studied the ability of Accutane® to modify or prevent such illness as depression and has presented no basis for asserting Accutane® is effective in improving the psychosocial and emotional well-being of such patients . . .[the] claim is particularly troublesome in light of information presented recently in a Dear Doctor letter, that Accutane® may cause depression, psychosis, and rarely . . . suicide. Id. See also infra notes 80-87 (discussing FDA’s regulation of unapproved uses). Unapproved, or “off-label,” uses have not been approved by FDA; information about the safety and effectiveness of the off-label use has not been submitted to, reviewed by, and approved by FDA, and, therefore, is prohibited from appearing on approved product labeling. See 21 C.F.R. § 202.1(e)(6)(i). 44 Id. § 202.1(e)(6)(ii). 45 Id. § 202.1(e)(6)(vii). 46 Id. § 202.1(e)(5)(ii). The fair balance provision is somewhat subjective, but the agency has given some guidance as to acceptable fair balance. See DDMAC, FDA, Current Issues and Procedures 1-2 (Apr. 1994) [hereinafter Current Issues]. 47 See Current Issues, supra note 46, at 3. 48 See Letter from Mark W. Askine, Regulatory Review Officer, DDMAC, FDA, to Carol D. Karp, Vice President Regulatory Affairs, Vivus, Inc. (Feb. 19, 1998) (notice-of-violation letter regarding broadcast advertisement for MUSE® that side effects insufficiently communicated to consumer and advertisement was not in fair balance because information about effectiveness was not presented in a manner comparable to presentation of effectiveness) (on file with FDA). Specifically, the voice-over that conveys risk information . . . is read at a pace that is too rapid to effectively communicate this important information, especially given the complexity of information containing ratios, percentages . . . [T]he statement “three percent of patients reported symptoms from lowering of blood pressure” does not adequately communicate . . . the potential severity of possible hypotensive related treatment emergent events associated with the drug . . . risk disclosure should indicate actual symptoms . . . observed in clinical trials for MUSE, including fainting, dizziness, and lightheadedness. Id.

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pares the advertisement’s emphases on risk information and drug benefit information in the “totality of the elements.”49 If the emphasis of benefit information outweighs that of risk information in the “totality of the elements,” then the advertisement is not fairly balanced and is misleading.50

2. Limits and Enforcement of FDA’s Authority Over DTC Advertising
There are, however, limits to FDA’s authority to regulate advertising content.51 FDA cannot require drug manufacturers to submit advertisements for review prior to publication.52 While the agency generally does not require preapproval of advertising content before publication, it does require as part of its postmarketing surveillance efforts that promotional materials be submitted to the agency at the time of initial publication.53 FDA’s enforcement against false or misleading advertisements usually begins with a “notice of violation” letter.54 If an advertisement is particularly egregious, FDA issues a warning letter.55 The notice of violation letter and warning letter generally order the pharmaceutical company to withdraw the advertisement immedi49 See Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Barbara A. Thompson, Regulatory Affairs, Glaxo-Wellcome (Oct. 30, 1997) (notice-of-violation letter for Flovent® DTC advertisement suggesting unapproved use on examination of “totality of elements”) (on file with FDA). 50 See id. The television medium, which allows for competing visual and audio messages, adds another twist to the totality of the elements test. If an audio message of the major statement contradicts the concurrent visual image, then the advertisement is not in fair balance. See Current Issues, supra note 46, at 3. To avoid conflicting messages, the agency advises advertisers to use consistent audio and visual messages. Id. 51 21 U.S.C. § 352(n)(3)(A) (FDCA § 502(n)(3)(A)). 52 Id. Section 502(n) explicitly prohibits FDA from promulgating regulations requiring prior approval of advertisement content, except in extraordinary circumstances. “Extraordinary circumstances” would exist when, for example, FDA receives information that a drug causes fatalities or serious injuries, and despite FDA notification, the sponsor fails to adequately publicize the information. 21 C.F.R. § 202.1(j)(1)(i)-(iii). See also id. §§ 314.550, 601.45 (requiring advertisement review in accelerated approval cases); id. §§ 807.87(e), 814.20(b)(10) (requiring advertisement review in premarket notifications and premarket approval applications). Preclearance of advertisements not only violates the congressional intent of FDCA, but may violate the First Amendment right to commercial free speech. U.S. CONST. amend. I; 21 U.S.C. § 352(n) (FDCA § 502(n)). Responding to the DTC advertising flood in the early 1990s, FDA informally requested manufacturers to voluntarily submit DTC advertisements for prepublication review. Letter from the FDA to the Pharmaceutical Industry (July 1993) (on file with FDA). See 21 C.F.R. § 202.1(j)(4) (stating “any advertisement may be submitted to the Food and Drug Administration prior to publication for comment”) (emphasis added); Announcement of Public Hearing on DTC Promotion, 60 Fed. Reg. 42,582, 42,582 (Aug. 16, 1995); Direct-to-Consumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996). The request led to industry confusion and criticism, prompting FDA to clarify its policy not to require preclearance of prescription drug advertising, but merely offering advertisement review to help resolve noncompliance issues in advance of publication. 61 Fed. Reg. at 24,314. 53 21 C.F.R. § 314.81(3)(i). FDA often requires the submission of advertisement content in cases of corrective advertising following sanctions for false or misleading claims. See, e.g., Letter from Minnie Baylor-Henry, Director, DDMAC, FDA, to Richard J. Kogan, CEO, Schering Corp. (July 31, 1997) (warning letter requiring FDA’s approval of corrective materials prior to dissemination) (on file with FDA); Letter from Lisa L. Stockbridge, Regulatory Review Officer, DDMAC, FDA, to Michael M. Rosen, Director, Regulatory Affairs, Forest Laboratories (Mar. 27, 1997) (notice-of-violation letter requiring FDA’s approval of corrective campaign materials prior to dissemination) (on file with FDA). Because FDA cannot review prescription drug advertisements prior to publication, it can prohibit an advertiser only from continuing a false or misleading advertisement after it has been published. 21 U.S.C. § 352(n) (FDCA § 502(n)). 54 See FOOD AND DRUG ADMIN., WARNING LETTER REFERENCE GUIDE, at 12 (Oct. 1994). A notice of violation or untitled letter is issued in response to illegal promotional activities when the relevant center is not prepared to support further agency action if the illegal activities are continued. Id. 55 See id. at 12. Warning letters are issued when the relevant center is prepared to support further agency action if the practice does not cease. Id. Notice-of-violation and warning letters provide the recipient an opportunity to take self-corrective measures and are informal and advisory. Id. The letters communicate the agency’s position on a matter, but do not commit FDA to enforcement action. Therefore, the agency does not consider a warning letter a final agency action for which it can be sued. Id.

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ately and may require a drug advertiser to orchestrate a corrective campaign to remedy any perceived damage from the false or misleading advertisement.56 If promotional claims are seriously misleading, FDA may seize affected products and/or enjoin the use of the promotions.57

3. Types of DTC Advertisements
Three types of direct-to-consumer advertisements emerge from the prescription drug advertising regulations: 1) reminder advertisements; 2) help-seeking or diseaseoriented advertisements; and 3) product-claim or indication advertisements.58 Reminder advertisements and help-seeking advertisements are exempt from the brief summary requirement because they do not reveal information about the effectiveness of the drug.59 Reminder advertisements showcase the name of the drug and drug company, but not a drug indication.60 Help-seeking advertisements encourage consumers with a particular condition, symptom, or disease to consult their doctor to discuss general treatment options, but do not identify a specific drug product indicated for the highlighted health problem.61 Product claim advertisements reveal the drug’s name and indication, and therefore must satisfy the brief summary requirement.62 Product claim advertisements on television were virtually nonexistent prior to the Draft Guidance because the brief summary requirement was too burdensome for the limited duration and broadcast medium.63 The new DTC broadcast guidance document aids drug manufacturers in developing product claim advertisements that satisfy the prescription drug advertising regulations.64

III. EVOLUTION OF FDA POLICY ON DIRECT-TO-CONSUMER ADVERTISING A. History of Pressure to Relax Restrictions on DTC Advertising
The first DTC prescription drug advertisements appeared in 1983.65 FDA, which did not yet have a direct-to-consumer advertising policy, reacted by declaring a voluntary moratorium on direct-to-consumer advertising and by pledging to examine the phenomenon and devise a policy.66 In 1985, under a new Commissioner of Food and
56 For example, a company may be asked to send a “Dear Doctor” letter or to run corrective advertisements. See supra note 53 and accompanying text. 57 21 U.S.C. § 334 (FDCA § 304). FDA can pursue criminal prosecutions of the company or individuals involved with false or misleading promotional claims that seriously threaten public health and welfare. 21 U.S.C. § 333 (FDCA § 303). 58 See 60 Fed. Reg. at 42,581, 42,582-83. 59 21 C.F.R. § 202.1(e)(2)(i). 60 Id. 61 See 60 Fed. Reg. at 42,582 (defining help-seeking advertisements). 62 See id. (defining product claim advertisements); 21 C.F.R. § 202.1(1). 63 See Nordenberg, supra note 7, at 7. 64 See Draft Guidance, supra note 10, at 1. 65 See Wayne L. Pines, New Challenges for Medical Product Promotion and Its Regulation, 52 FOOD & DRUG L.J. 61, 62 (1997). In 1981, Merck & Co. launched advertisements in Reader’s Digest and newspapers announcing its new pneumonia vaccine, Pneumovax®. See Prescription for Profit, ADVER. AGE, Mar. 16, 1998, at 4, available in 1998 WL 6629328. Until that time, drug manufacturers generally limited prescription drug promotion to healthcare professionals. See 60 Fed. Reg. at 42,581. 66 See Arthur Hull Hayes, Jr., Comm’r of Food and Drugs, Direct-to-Consumer Advertising of Prescription Drugs: Moratorium, Address Before Pharmaceutical Advertising Council (Feb. 17, 1983). In 1984, a symposium sponsored by the University of Illinois and the Stanford Research Institute was held to discuss consumerdirected prescription drug advertising. See 60 Fed. Reg. at 42,581.

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Drugs, the moratorium was lifted, but no policy was announced67 because the agency concluded that existing regulations could “provide sufficient safeguards to protect consumers.”68 In the late 1980s, drug manufacturers launched advertisements on three, now-defunct, physician-oriented television networks: Lifetime Medical Television, American Medical Television, and Medical News Network.69 FDA was concerned about exposing consumers to prescription drug broadcast advertisements that were not intended for unsophisticated viewers.70 The appointment of Dr. David A. Kessler as the Commissioner of Food and Drugs in late 1990 is associated with the agency’s more stringent enforcement of advertising policies.71 In the early 1990s, Dr. Kessler initiated two high-profile enforcement cases against drug companies for advertising violations.72 A study published in 1992 in the Annals of Internal Medicine found ninety-two percent of pharmaceutical advertisements in ten leading journals violated the FDA’s labeling and advertising guidelines.73 Although the study was criticized as scientifically inadequate, it was widely reported in the popular press and prompted legislative proposals requiring advertisement preapproval by an independent review group or by FDA.74 Dr. Kessler was concerned about unauthorized therapeutic substitutions75 and unsubstantiated claims of superiority.76 Although comparative claims are permissible in prescription drug advertisements, claims must be well-supported with clinical data.77 FDA generally views comparative claims unfavorably because claimed differences in safety or effectiveness based on widespread clinical usage or epidemiological data undermine FDA’s role of ensuring product safety and effectiveness prior to marketing.78 FDA adopts a similar philosophy to the promotion of products for unapproved uses.79
67 Withdrawal of Moratorium on Direct-to-Consumer Advertising of Prescription Drugs, 50 Fed. Reg. 36,677 (Sept. 9, 1985) (Frank E. Young, Comm’r of Food and Drugs). 68 Id. 69 See Pines, supra note 65, at 62. 70 Id. 71 Id. at 61, 62. See David A. Kessler & Wayne L. Pines, The Federal Regulation of Prescription Drug Advertising and Promotion, 264 JAMA 2409 (1990); FDA Talk Paper (July 18, 1991) (noting increased emphasis on compliance of prescription drug promotion with ethical and legal standards); David A. Kessler et al., Therapeutic Class Wars, Drug Promotion in a Competitive Marketplace, 331 NEW ENG. J. MED. 1350 (1994) [hereinafter Kessler, Therapeutic Class Wars]. See also Thomas M. Hayes, Drug Labeling and Promotion: Evolution and Application of Regulatory Policy, 51 FOOD & DRUG L.J. 64 (1996) [hereinafter Hayes] (discussing FDA’s enforcement response to pharmaceutical manufacturers’ marketing initiatives in the early 1990s). Dr. Kessler had personal and professional interest in marketing issues. See Pines, supra note 65, at 62. 72 See Pines, supra note 65, at 62. 73 Martin S. Wilkes et al., Pharmaceutical Advertisements in Leading Medical Journals: Expert’s Assessments, 116 ANNALS OF INTERNAL MED., 912-19 (1992) (reporting survey of physicians and pharmacists’ comparisons of 109 full-page advertisements with FDA guidelines and assessments of their educational value). 74 See Paul H. Rubin, Are Pharmaceutical Ads Deceptive?, 49 FOOD & DRUG L.J. 7, n.3 (1994). 75 See Kessler, Therapeutic Class Wars, supra note 71, at 1350. Unauthorized therapeutic substitutions or “switch campaigns” are industry efforts to switch patients from their originally prescribed medications to “metoo” drugs marketed by the companies. Id. at 1352. 76 Id. at 1350. Kessler attributed switch campaigns and unsubstantiated superiority claims to competition within therapeutic drug classes, stating: “The preponderance of me-too drugs has created a highly competitive marketplace for prescription drugs. Pharmaceutical companies are waging aggressive campaigns to change prescribers’ habits and to distinguish their products from competing ones, even when the products are virtually indistinguishable.” Id. Between 1989 and 1993, FDA’s Center for Drug Evaluation and Research (CDER) approved 127 new molecular entities, but only a minority offered a clear clinical advantage over existing therapies. Id. at 1350 n.1. 77 Claims made as to product safety and effectiveness in comparison with competing products are subject to the same standards of review as safety and efficacy claims in product labeling, that is, claims must be supported by substantial evidence or substantial clinical trial experience. See Current Issues, supra note 46, at 3. 78 See Kessler, Therapeutic Class Wars, supra note 71, at 1351; Hayes, supra note 71, at 62. 79 See infra notes 80-86 and accompanying text.

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As noted, the advertising of an unapproved, or “off-label,” use is false or misleading.80 Manufacturers’ promotion of unapproved uses has been a contentious issue for FDA and the subject of citizen petitions and legal challenges.81 Promotion of unapproved uses is an issue primarily in physician-targeted advertising, rather than in DTC advertising.82 FDA was forced to defend its restrictions on the promotion of unapproved uses in response to a legal challenge in 1994, which charged FDA’s policy violated the First Amendment right to commercial free speech.83 FDA argued that its role as a consumer-protection agency is to ensure a product is safe and effective for its intended use when used according to its product labeling.84 If a product is promoted for an unapproved use, one that the FDA has not ensured to be safe and effective prior to marketing, then FDA’s role as a consumer protection agency is undermined.85 In other words, the advertising of unapproved uses must be categorized as false or misleading, or FDA’s role is invalidated.86 FDA’s sensitivity about the promotion of unapproved uses is reflected in the agency’s monitoring of advertisements; if an advertisement remotely “suggests” that the drug product might be used to treat an unapproved use, the manufacturer will be asked to withdraw the advertisement.87

B. The Pressure Mounts: New Initiatives to Increase the Access to Prescription Drug Product Information
Under pressure to increase patient access to prescription drug information, FDA undertook several initiatives to improve the quality and accessibility of prescription
80 See 21 U.S.C. §§ 355(a), 352(a), 352(f), 331(a), and 331(d); 21 C.F.R. § 202.1(e)(6)(i). FDA permits information about unapproved uses of approved drugs to be disseminated to physicians through peer-reviewed reprints. FDA Modernization Act of 1997 (FDAMA), Pub. L. No. 105-115, § 401, 111 Stat. 2356 (1997) (codified at 21 U.S.C. § 360aaa). 81 See infra notes 83-87 and accompanying text. See also Request for Comments on Citizen Petition Regarding the FDA’s Policy on Promotion of Unapproved Uses of Approved Drugs and Devices, 59 Fed. Reg. 59,820 (Nov. 18, 1994); Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074 (Dec. 3, 1997). 82 See 59 Fed. Reg. at 59,820; 62 Fed. Reg. at 64,074. But see Paul H. Rubin, FDA Advertising Restrictions: Ignorance is Death, in HAZARDOUS TO OUR HEALTH? FDA REGULATION OF HEALTH CARE PRODUCTS (Robert Higgs ed. 1995) (advocating promotion of off-label uses to consumers, as well as to physicians). 83 Washington Legal Found. v. Kessler, 880 F. Supp. 26, 27-28 (D.D.C. 1995). In 1994, the Washington Legal Foundation filed a citizen petition in response to an FDA policy proposal limiting manufacturers’ dissemination of information about off-label uses of approved drugs to physicians. See 59 Fed. Reg. at 59,820. 84 See 62 Fed. Reg. at 64,079. 85 See Hayes, supra note 71, at 62. 86 Id. Furthermore, false or misleading advertising is not a valid use of commercial speech, so restrictions on advertising of unapproved uses are not invalid. See 62 Fed. Reg. at 64,079 (analyzing ban on promotion of unapproved uses favorably using four-prong test articulated by Supreme Court in Central Hudson Gas & Electric Corp. v. Public Serv. Comm’n of New York, 447 U.S. 557 (1980)). See also Rhode Island v. Rhode Island Liquor Stores Assoc., 317 U.S. 484, 487 (1996) (declaring state ban on nonmisleading commercial speech unconstitutional); Virginia State Bd. of Pharm. v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976) (declaring state ban on advertising of drug prices unconstitutional); Coyne Beahm, Inc. v. Kessler, 966 F. Supp. 1374, 1398-99 (M.D.N.C. 1997) (holding Congress did not intend to grant FDA authority to regulate advertising or promotion under section 360j(e), which permits FDA to restrict “sale, distribution, or use” of restricted devices); Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28, 1996). 87 See Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Barbara A. Thompson, Regulatory Affairs, Glaxo Wellcome (Oct. 30, 1997) (notice-of-violation letter that Flovent® DTC advertisement depicting Jackie Joyner Kersee engaged in strenuous physical activity suggested product was approved for use in exercise-induced bronchospasm); Letter from Lisa L. Stockbridge, Regulatory Review Officer, DDMAC, FDA, to Eloise R. Scott, Associate Director, Regulatory Affairs, SmithKline Beecham Pharmaceuticals (Mar. 9, 1998) (notice-of-violation letter that Paxil® T-shirts distributed at children’s health fair suggested product was approved for use in children).

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drug information available to patients.88 Medical Guides (MedGuides), patient-oriented labeling intended for all patients receiving new and refilled prescriptions, are a product of that initiative.89 MedGuides are a reincarnation of patient package inserts (PPIs), which were required by FDA in the early 1980s.90 The PPI initiative was revoked two years after it was instituted, when a pilot program led the agency to determine that the mandatory nature of the program inhibited industry initiative and innovation in providing patients with product information.91 MedGuides were spurred by concern about the technical nature of product information and the differences in education level and information needs of patients and physicians.92 Like PPIs, the MedGuide proposal was challenged by the pharmaceutical industry.93 The final MedGuide policy was modified to become a voluntary private sector initiative.94 FDA’s goal for the MedGuide initiative is to distribute useful patient information to 75% of patients receiving new prescriptions by the year 2000, and to 95% by the year 2006.95 From 1994 to 1997, the agency received several citizen petitions on DTC prescription drug advertising from consumer advocacy groups and the pharmaceutical industry.96 Petitions from consumer groups varied. Some groups lobbied for the elimination of all restrictions on DTC prescription drug advertising, while others lobbied
88 In January 1996, the Secretary of the Department of Health and Human Services (DHHS) accepted a Keystone Center report containing guidelines for improving patient access to prescription drug information. See DEP’T OF HEALTH & HUMAN SERVS., HHS NEWS, NO. P97-02 (Jan. 14, 1997) (announcing Secretary’s plan to adopt “Action Plan for the Provision of Useful Prescription Medicine Information,” a voluntary plan in which manufacturers distribute patient labeling, termed “Medical Guides” to patients receiving prescription drug products). See also 62 Fed. Reg. at 43,172. 89 FDA Proposal, 60 Fed. Reg. 44,182 (Aug. 24, 1995). 90 See FDA Order, 45 Fed. Reg. 60,754 (Sept. 12, 1980); Howard M. Rowe, Patient Package Inserts: The Proper Prescription?, 50 FOOD & DRUG L.J. 95, 95 (1995). PPIs were product information written for a nontechnical audience and required to accompany the dispensed prescription drug product. See 45 Fed. Reg. at 60,754. The Pharmaceutical Manufacturers’ Association challenged FDA’s authority to mandate PPIs, but the court ultimately held FDA had the authority, extending to PPIs, to promulgate regulations to ensure labeling is not false or misleading. Pharmaceutical Mfrs. Assn. v. FDA, 484 F. Supp. 1179, 1186 (D. Del.), aff’d, 634 F.2d 106 (3d Cir. 1980) (per curiam). 91 See FDA Order, 47 Fed. Reg. 39,147 (Sept. 7, 1982). Some drug classes, such as estrogenic products and oral contraceptives, are still required to include PPIs. See 42 Fed. Reg. 37,636 (Sept. 20, 1977) (codified at 21 C.F.R. § 310.515). Several private sector organizations voluntarily distribute patient information leaflets, including the American Medical Association, American Society of Hospital Pharmacists, U.S. Pharmacopoeia, and the American Association of Retired Persons. 47 Fed. Reg. at 39,147, pmbl. 92 See DHHS, supra note 88. See also Proposed Prescription Drug Labeling Requirements: Medical Guides, 60 Fed. Reg. 44,182 (Aug. 24, 1995); Public Meeting Announcement for Issue of Professional Product Labeling, 60 Fed. Reg. 52,196 (Oct. 5, 1995) (announcing public meeting to discuss product labeling for healthcare professionals). 93 Congress threatened to table the policy permanently if FDA did not first accept and respond to public comments on the proposal. See Pub. L. No. 104-180, 110 Stat. 1569 (1996) (codified at 21 U.S.C. § 353). See, e.g., FDA Reform Legislation: Hearing on FDA Proposed MedGuide Regulation Before the Subcomm. on Health of the House Commerce Comm., 104th Cong., 2d Sess. (1996), available in WESTLAW, 1996 WL 270840 at *3 (statement of John M. Scheels, Director of Regulatory Affairs, Eckerd Corp.) (opposing proposed “MedGuide” regulations as unnecessary burdens on pharmacy providers). 94 See DHHS, supra note 88. 95 See 60 Fed. Reg. 59,570, 59,571 (Nov. 28, 1995). 96 See No. 95P-0224/CP2 (Nov. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,466; No. 95P-0224 (July 1995) Food Drug Cosm. L. Rep. (CCH); No. 95P-0104 (Apr. 1995) Food Drug Cosm. L. Rep. (CCH) ¶ 41,146. FDA regulation of Internet advertising also has been the subject of citizen petitions, and FDA has undertaken the development of an policy addressing Internet promotion. See No. 96P-0501/CPI (Dec. 1996) Food Drug Cosm. L. Rep. (CCH) ¶ 41,755; Notice of Public Meeting on Promotion of FDA-Regulated Products on the Internet, 61 Fed. Reg. 48,707 (Sept. 16, 1996); Milton Liebman, FDA Hearings on What the Internet Can Show, 31 MED. MKTG. & MEDIA 62 (1996). See also Peter Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355, 356-61 (1996).

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to prohibit DTC advertising.97 DTC advertising opponents argue that consumers are not sophisticated enough to filter promotional claims about prescription drugs and that physicians will be pressured to write unnecessary prescriptions.98 Proponents argue that DTC advertisements will lead to improved physician-patient relations, increase compliance with drug therapy, lower drug prices, and most importantly, will increase consumer knowledge about available prescription drug therapy, thereby empowering consumers.99 Over the last decade, the traditional healthcare structure has shifted from fee-forservice, private practices, which fostered individual patient-doctor relationships, to managed care health plans, where employers generally arrange healthcare benefits on behalf of employees.100 Consumer autonomy in making healthcare choices has diminished considerably as a result.101 Consumers are now more limited in their choice of physician, health treatments, and prescription drug products.102 In addition, the individual patient-doctor relationship has waned as preferred provider organizations (PPOs) and health maintenance organizations (HMOs) flourish.103 As a result, consumers take greater responsibility for their own health and greater control of their disease management and treatment.104 Consumers must be informed about diseases and treatment options to be optimal health care decision-makers.105 The pharmaceutical industry also has been affected by the changing healthcare environment. More than half of the U.S. population is covered by some form of managed drug plan, which often have restrictive drug formularies.106 HMOs commonly employ prescription drug utilization techniques that limit the dispensing of drug products.107 Pharmaceutical companies recognize that DTC advertisements can be used to overcome drug utilization controls and to create consumer awareness and loyalty to prescription brand names.108 In addition, drug companies often compete for consumers in overcrowded therapeutic classes.109 The incentive to market products in these
97 See 60 Fed. Reg. at 42,582 (listing citizen petition requests for the agency to ban DTC advertising, issue a moratorium on new DTC restrictions, promulgate new regulations on prescription drug advertising, and refrain from any DTC restriction in the interim). 98 Id. See also Borzo, supra note 11, at 4, 5 (noting assertions of public interest groups, e.g., Public Citizen, that consumers cannot counter effects of sophisticated advertising and that DTC will lead to overprescribing); Letter from Larry D. Sasich & Sidney M. Wolfe, Public Citizen’s Health Research Group to FDA (Aug. 12, 1996) (enumerating DTC advertising concerns), available at Public Citizen’s website <www.citizen.org/ hrg/PUBLICATIONS/1400.htm>; Lynnette R. Bradley & Julie Magno Zito, Direct-to-Consumer Prescription Drug Advertising, 35 MED. CARE 86, 88 (1997) (noting that consumers lack “necessary clinical and pharmacologic expertise to accurately evaluate and comprehend prescription drug advertising” and that DTC may encourage unnecessary drug consumption). But see Media Rules Change, supra note 7, at *2 (disputing physician capitulation to patient demands). 99 See 60 Fed. Reg. at 42,582. 100 See E. Havvi Morreim, Diverse and Perverse Incentives of Managed Care: Bringing Patients Into Alignment, 1 WIDENER L. SYMP. J. 89 (1996). 101 See id at 97-98.. 102 See id. 103 See id. at 101. 104 See Ernestine McCarren, Is DTC Advertising a Palatable Medium for Managed Care Organizations?, 31 MED. MKTG. & MEDIA 57, 58 (1996) 105 See id. at 58; Borzo, supra note 11, at 3 (quoting Paul Rubin, Emory University economics professor, on consumers’ increased leverage in dealing with managed care companies because of increased information). 106 See McCarren, supra note 104, at 58. 107 See id. 108 See Sandulli, supra note 14, at 42. Building consumer brand name loyalty also is a strategy used in anticipation of a prescription to over-the-counter switch. Id. at 44. 109 See Kessler, Therapeutic Class Wars, supra note 71, at 1350. For example, in the nasal allergy pharmaceutical market, Schering-Plough markets Claritin® and Claritin-D®, Merrell Pharmaceuticals markets Allegra®, Glaxo Wellcome markets Flonase® and Vacenase®, Rhone-Poulenc Rohr markets Nasalcort®, and Boehringer Ingelheim markets Atrovent®. See also Schering-Plough, Claritin®, Allergy Relief Zone (visited Mar. 30, 1998) <http://www.claritin.com>.

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categories is the financial return, which can top $1 billion in a single therapeutic category.110 Because prescription drug advertising regulations impaired their ability to reach consumer markets, drug manufacturers pushed FDA to relax restrictions on DTC advertising.111 External pressure from the industry and consumers contributed to FDA’s new DTC broadcast guidelines.112 The absurd, bewildering television commercials that resulted from drug manufacturers’ attempt to comply with the regulations also provided an impetus.113 It was common for a patient to ask her gynecologist if she was a candidate for Claritin®, an antihistamine product.114 Rather than protecting the public from spurious claims, FDA regulations inadvertently withheld information needed by consumers, leaving the consumer misinformed and in a worse position.115 The advertising regulations require broadcast advertisements to include a brief summary if an indication for the drug is promoted, but the lengthy brief summary is too burdensome for 30-second television commercials.116 The “adequate provision” alternative to the brief summary requirement in broadcast advertisements was ambiguous.117 Without clear direction from FDA regarding its policy, the regulations were a “Catch-22” for drug manufacturers. For the last several years, drug companies have been “pushing the envelope” by airing indication advertisements without including brief summaries.118 FDA sent numerous notices of violations and warning letters informing advertisers of their failure to meet the adequate provision requirement.119 The ambiguity of the adequate provision regulatory created an FDA enforcement problem.120

C. Proceeding With Trepidation: FDA Approach to DTC Policy Setting
Until recently, FDA still occupied its 1983 position: it had articulated no clear
110 See Kessler, Therapeutic Class Wars, supra note 71, at 1350. Sales in the top eighteen therapeutic categories each exceeded $1 billion in 1993. Id. Drug companies selectively advertise drugs, reserving big DTC campaigns for drugs with large populations needing chronic treatment, such as for asthma and diabetes; acute therapy drugs with maintenance follow-up; long treatment cycles; and seasonal treatment. See Sandulli, supra note 14, at 42; Jan Hodnett, Targeting Consumers, 30 MED. MKTG. & MEDIA 91, 92-93 (1995). 111 See Direct-to-Consumer Promotion Public Hearing, 60 Fed. Reg. 42,581 (Aug. 16, 1995); Direct-toConsumer Promotion, 61 Fed. Reg. 24,314 (May 14, 1996); Kessler, Therapeutic Class Wars, supra note 71, at 1350. 112 See supra notes 93-109 and accompanying text. Congress also has been influenced FDA’s advertising policy. For example, FDA has been the subject of several bills and legislative proposals seeking to limit the agency’s authority over prescription drug promotion. See FDAMA, H.R. 1742, 104th Cong., 1st Sess. (1995). See also H.R. 2932, 104th Cong., 2d Sess. (1996); S. 1744, 104th Cong., 2d Sess. (1996); S. 1197, 104th Cong., 1st Sess. (1995). 113 See supra notes 1-4 and accompanying text. 114 Nordenberg, supra note 7, at 7 (quoting Alex Giaquinto, Senior Vice President, Worldwide Regulatory Affairs, Schering-Plough Corp. (manufacturer of Claritin®)). 115 See supra notes 99-105 and accompanying text. 116 See supra notes 32-34 and accompanying text. 117 See supra notes 39-42 and accompanying text. 118 See Letter from Russell Fleischer, Regulatory Review Officer, DDMAC, FDA, to Michelle N. Hardy, Regulatory Affairs, Glaxo-Wellcome (Jan. 28, 1997) (notice-of-violation letter for Valtrex® broadcast advertisement making indication claims without a brief summary); Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Marketed Products Support, Schering Corp. (Mar. 3, 1997) (notice-of-violation letter for Claritin® broadcast advertisement making indication claims without brief summary). 119 Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Marketed Products Support, Schering Corp. (Mar. 26, 1997); Letter from Minnie Baylor-Henry, Director, DDMAC, FDA, to Richard U. De Schutter, Chairman, President & CEO, G.D. Searle & Co. (Nov. 21, 1997). 120 See supra note 118-19.

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policy on DTC advertising.121 Since 1983, the dynamics have changed, however, and FDA is under considerable pressure to establish a workable policy.122 For the past decade, FDA set a de facto policy through individual regulatory warning letters to pharmaceutical companies.123 In addition, FDA announced a public hearing in 1995 to address DTC prescription drug advertising.124 The hearing was to be the first step in developing a comprehensive DTC advertising policy.125 In May 1996, FDA requested comments on the brief summary requirement and the communication of risk information in print and broadcast media.126 In August 1997, the agency published the first product of the DTC initiative in the form of the Draft Guidance.127 Guidance documents are not legally binding on the agency and can be issued or withdrawn without public input.128 The agency claims to seek public input on certain guidance documents, such as those that set forth first interpretations of statutory or regulatory requirements or make major changes in interpretation or policy.129 While not required to do so, FDA has sought public input on developing its DTC policy, including on the Draft Guidance.130 Unlike regulations, which are subject to administrative rulemaking procedures,131 the agency can change the policy documents informally to coincide with its “current thinking.”132 Although guidance documents are not the product of rulemaking, they are based on the regulations, which have the force of law. Consequently, guidance documents must be abided by, or legal sanctions could result.133

IV. NEW DIRECT-TO-CONSUMER BROADCAST ADVERTISING POLICY A. Adequate Provision of Product Labeling Information
As noted, all prescription drug broadcast advertisements must include information about the major risks, in audio or audio and visual parts of the broadcast, and
See supra notes 67-121 and accompanying text. See supra notes 93-123 and accompanying text. 123 See Pines, supra note 65, at 62. 124 Direct-to-Consumer Promotion Public Hearing Announced, 60 Fed. Reg. 42,581 (Aug. 16, 1995). 125 See id. 126 Direct to Consumer Promotion, 61 Fed. Reg. 24,314, 24,315 (May 14, 1996). 127 62 Fed. Reg. at 43,171. The Draft Guidance did not announce a dramatic change or stray from the original prescription drug advertising regulations; rather it merely clarified FDA’s interpretation of the all-important phrase “adequate provision” in prescription drug broadcast advertising. Id. 128 See Notice of the FDA’s Development, Issuance, and Use of Guidance Documents, 62 Fed. Reg. 8961, 8963 (Feb. 27, 1997); Community Nutrition Inst. v. Young, 818 F.2d 943 (D.C. Cir. 1987) (holding guidance documents not binding on FDA). Guidance documents include “documents prepared by FDA, applicants/sponsors, and the public” that “describe the Agency’s policy and regulatory approach to an issue.” 62 Fed. Reg. at 8961. 129 Id. at 8962, 8964. 130 See 62 Fed. Reg. at 43,171. In issuing the Draft Guidance, FDA requested comments and other information pertaining to the Draft Guidance policy’s effectiveness. Id. 131 See 62 Fed. Reg. at 8962 (discussing Administrative Procedure Act requirements for rulemaking). 132 Id. 133 See supra notes 55-60 and accompanying text for FDA enforcement authority. Guidance documents will not use mandatory language. 62 Fed. Reg. at 8963. Establishing policy via guidance documents gives the public less input and FDA more flexibility. While the lack of public involvement in the development of guidance documents is a valid concern, it is preferable for the agency to announce its policy in the form of guidance documents, rather than establishing policy piecemeal in regulatory warning letters to individual drug manufacturers. Id; Community Nutrition Inst., 818 F.2d at 943. The pharmaceutical industry, however, should note that the agency can change its policy with no public input or formal administrative procedure.
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must ensure adequate provision of product labeling.134 If an advertiser does not make adequate provision of the product labeling, the advertiser must include a brief summary in the broadcast advertisement.135 The Draft Guidance describes how the adequate provision requirement can be met.136 The recommendations in the Draft Guidance are not the only methods of achieving adequate provision; alternative methods of satisfying the provision may be used.137 The Draft Guidance describes four methods for disseminating FDA-approved product labeling to consumers: 1) a toll-free telephone number; 2) a reference to a print advertisement or brochures placed in publicly accessible places; 3) a recommendation to ask a pharmacist or doctor about further information about the product; and 4) an Internet website.138 An advertisement must include all four methods to fulfill the adequate provision requirements.139 FDA’s intention is to ensure that the majority of a potentially diverse population has the opportunity to receive the advertised product’s approved labeling.140 FDA may take issue with drug manufacturers’ attempts to minimize side effect information in broadcast advertisements.141 The major statement is often combined with the image of people engaged in some life-affirming activity, such as pushing a child on a bike or picking flowers with a child in a grassy field.142 While FDA may not find these advertisements objectionable per se, advertisers should be wary of presenting contradicting visual and audio messages that minimize the risk information compared to the benefit information143 or promote unapproved uses.144 In response to criticism that it does not have the resources to police the flood of prescription drug advertisements, the agency claims that it has sufficient resources to
134 21 C.F.R. § 202.1(e)(1). The Draft Guidance does not change the major statement provision. Draft Guidance, supra note 10, at 1. 135 21 C.F.R. § 202.1(e)(1). See also supra notes 32-34 and accompanying text. 136 Draft Guidance, supra note 10, at 1. 137 Id. 138 Id. at 2. See, e.g., Astra Merck: Prilosec® advertisement (CBS television broadcast, Mar. 11, 1998); Glaxo Wellcome: Flonase® advertisement (CBS television broadcast, Mar. 11, 1998); Merck: Zocor® advertisement (CBS television broadcast, Mar. 27, 1998); Bristol-Myers Squibb: Pravachol® advertisement (CBS television broadcast, Mar. 27, 1998). 139 See Borzo, supra, note 11, at 3. “There seems to be some miscommunication . . . so let me clarify it here: To comply with this approach, an advertiser would have to include all four of these components.” Id. (quoting Nancy Ostrove, FDA public health analyst) (emphasis added); Letter from Stephen W. Sherman, Regulatory Review Officer, DDMAC, FDA, to Vivian Chester, Vice President, Regulatory Affairs, McNeil Consumer Products Co. (Mar. 19, 1998) (notice-of-violation letter regarding broadcast ad for Nicotrol Inhaler® charging adequate provision requirement was not met because advertisement recommended viewer to “ask your doctor,” rather than “ask your doctor for additional product information.”); Letter from Jean E. Raymond, Regulatory Review Officer, DDMAC, FDA, to Brenda Horn, Regulatory Affairs, Gualderma Laboratories, Inc. (Mar. 20, 1998) (notice-of-violation letter regarding Metrogel® broadcast advertisement, stating that the advertisement must include reference to product information in “magazines, newspapers, or brochures” to satisfy adequate provision requirement). 140 Draft Guidance, supra note 10, at 2. 141 See Letter from Warren F. Rumble, Regulatory Review Officer, DDMAC, FDA, to Richard Gural, Vice President Regulatory Affairs, Alcon Laboratories, Inc. (Mar. 20, 1998) (notice-of-violation letter regarding Patanol® broadcast advertisement that stated “a few people may experience side effects, like a headache,” which FDA considered inadequate presentation of risk information). 142 See, e.g.,. Zocor®, supra note 138Flonase®, supra note 138. See also Elizabeth A. Rothermich et al., Health-Related Quality of Life Claims in Prescription Drug Advertisements, 53 AM. J. HEALTH-SYST. PHARM. 1565, 1567 (1996). 143 See, e.g., Stephen W. Sherman, supra note 139, at 1 (notice-of-violation letter regarding broadcast advertisement for Nicotrol Inhaler® that failed to present risk information prominently “during the audio presentation of the risk information, six different visual presentations distract attention from” and “interfere with” risk presentation). 144 See supra notes 44-51 and accompanying text.

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protect the public from false and misleading claims.145 The agency also intends to rely on consumer advocacy groups and competing drug manufacturers to help it police prescription drug advertisements.146 The Draft Guidance advises advertisers as to the procedure to follow when a consumer seeks information about a drug in response to the adequate provision mechanism.147 In all cases, the consumer should receive FDA-approved product labeling or a brief summary of that labeling.148 When calling the toll-free telephone number, the consumer should be given the choice of having labeling mailed or faxed in a timely manner,149 or having the information read to her over the telephone.150 The print advertisements to which consumers are referred in the broadcast advertisement should appear “concurrently in publications that reach the exposed audience.”151 Presumably, these publications are popular magazines having large circulations, although no further instruction is given in the Draft Guidance.152 Print advertisements are required to present only a brief summary of product labeling, so the print advertisement used as an adequate provision component also must supply a toll-free number or an address whereby the consumer can obtain the full package labeling.153 As an alternative to placing an advertisement in a popular magazine, the sponsor may provide “sufficient numbers” of brochures containing package labeling in a “variety of publicly accessible places.”154 Pharmacies, doctors’ offices, grocery stores, and public libraries are listed as examples.155 Brochures must be “available at enough sites so that most consumers exposed to the broadcast advertisement can obtain labeling without traveling beyond their normal range of activities.”156 The Draft Guidance fails to elaborate several important points. For example, it does not elaborate on the required referral to a pharmacist or physician for additional product information.157 In fact, it does not require drug manufacturers to supply healthcare providers with approved product labeling information about advertised prescription drugs.158 The guidance also does not elaborate on the Internet website
145

See Media Rules Change, supra note 7 (quoting Robert Temple, Associate Director of Medical Policy,

FDA).
146 See id. See, e.g., Letter from Lesley R. Frank, Regulatory Counsel, DDMAC, FDA, to Joseph S. Sonk, Senior Director, Women’s Healthcare Products, Wyeth-Ayerst Research (Oct. 30, 1997) (expressing thanks for notification of misleading promotional claims made by competitor Parke-Davis). Drug companies also must maintain credibility with consumers; this requirement serves as an incentive to follow FDA guidelines, thereby avoiding a corrective campaign. See Media Rules Change, supra note 7. 147 Draft Guidance, supra note 10, at 1. 148 Id. 149 Id. at 2. “Timely manner” means labeling must be mailed within two days of the request for receipt by the requester within four to six days and must be faxed on completion or within a few hours of the call. Id. at 2. See also Letter from Joan Hankin, Regulatory Review Officer, DDMAC, FDA, to Ronald J. Garutti, Director, Schering Corp. (Mar. 10, 1997) (notice-of-violation letter stating “DDMAC does not consider a two-three week actual response time for receipt of the Claritin® approved product labeling to meet the ‘adequate provision’ requirements.”). 150 Draft Guidance, supra note 10, at 2. The Draft Guidance suggests this requirement can be fulfilled by offering the consumer a selection of prerecorded labeling topics. Id. 151 Id. 152 Prescription drug commercials have referred to print advertisements in People, Newsweek, and Cooking Light. For example, see Prilosec®, supra note 138; Flonase®, supra note 138; Pravachol®, supra note 138; Zocor®, supra note 138. 153 Draft Guidance, supra note 10, at 2. See 21 C.F.R. § 202.1(e)(1); supra notes 32-34 and accompanying text. 154 Draft Guidance, supra note 10, at 2. 155 Id. 156 Id. 157 Id. 158 Id.

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component, except to note that the website must provide the approved product labeling.159 The uniform resource locator (URL) address does not have to appear in the broadcast, but instead may be provided via the toll-free telephone number.160 FDA expresses concern in the Draft Guidance about making information available to all population segments, including those who are not technologically sophisticated, those without access to the Internet and fax machines, and those who “hesitate to actively request or receive” product information.161 Further, FDA encourages advertisers to provide consumers with nonpromotional, consumer-friendly product information, along with the approved product labeling.162

B. Examples of Industry’s Adequate Provision of Information
Although the Draft Guidance choreographs what should happen when a consumer calls the toll-free telephone number flashed on the television screen during a prescription drug commercial, the industry has taken liberties with FDA’s directions.163 For example, a consumer call in response to a DTC broadcast advertisement has become a prime marketing opportunity for drug manufacturers.164 A caller might be asked questions ranging from basic demographic data to personal medical information about disease symptoms or health habits.165 Although the caller may be assured as to confidentiality, this telephone survey is not anonymous, as the caller must reveal name and address information to receive the desired product labeling.166 As a consequence of revealing demographic information, a consumer may be subjected to future unsolicited contact from the drug company via direct mail,167 e-mail, the
159 Id. See supra notes 88-121 and accompanying text for issues surrounding FDA regulation of prescription drug promotion. See infra notes 168 for drug manufacturers’ use of Internet websites to fulfill the adequate provision requirement. 160 Draft Guidance, supra note 10, at 2. 161 Id. 162 Id. (emphasis added). The Draft Guidance gives FDA-approved patient labeling as an example of nonpromotional, consumer-friendly product information, such as PPIs for estrogenic drugs. Id. 163 See infra notes 164-69 and accompanying text. 164 The call is used to solicit consumer information from the targeted patient population, which could be used in subsequent marketing campaigns. See infra note 166 and accompanying text. 165 Telephone interview with Renova® information specialist, Ortho Pharmaceuticals Corp. (Mar. 2, 1998) (requesting basic demographic information from caller); telephone interview with Valtrex® information specialist, Glaxo Wellcome (Feb. 20, 1998) (requesting personal health information from caller in a survey, including such questions as “How long have you had Herpes?” and “What other treatments have you sought?”). 166 See telephone interview with Renova® information specialist, supra note 165; telephone interview with Valtrex® information specialist, supra note 165. Notably, medical records and information shared by a patient with his or her physician generally are protected. See, e.g., Drug Abuse and Treatment Acts and Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act, 42 U.S.C. §§ 290dd-3, 390ee-3 (West 1994 & Supp. 1996) (imposing rigorous requirements on disclosure of information from alcohol and drug abuse treatment programs); Berry v. Moench, 331 P.2d 814 (Utah 1958) (imposing liability on doctors for violating duty of confidentiality expressed or implied in state licensure or privilege statute); Felis v. Greenberg, 273 N.Y.S. 2d 288 (1966); Humphers v. First Interstate Bank of Or., 696 P.2d 527 (Or. 1985) (holding physician had duty under state statute to keep patient’s medical information confidential). 167 See, e.g., HEADWAY: THE MIGRAINE NEWSLETTER, Vol. 3, No. 3 (published by Glaxo Wellcome, Shawnee Mission, KS) (received following earlier request and receipt of approved Imitrex® labeling). Accompanying the product labeling, a consumer may receive any of the following: • a list of doctors in the area that prescribe the product (see Letter from Sherrin E. Johnson, Senior Product Director for Renova®, Ortho Pharmaceuticals Corp., to author (Mar. 28, 1998) (on file with author) [hereinafter Renova® packet]); • a diary in which to record symptoms and bring to a doctor appointment (see Letter from Astra Merck, to author (Mar. 22, 1998) (diary accompanying Prilosec® product information packet to help doctor “evaluate your symptoms”) (on file with author));

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Internet,168 or even telephone. Drug manufacturers also could use information obtained from consumer surveys to support comparative claims.169 Using consumer requests for additional product information as a marketing tool raises issues about the intent of the Draft Guidance and the adequate provision requirement, as well as about the confidentiality of information revealed by the consumer. It is not clear what liberties the drug company may take with information not promised to be held in confidence. FDA, however, may perceive the solicitation of information from consumers for marketing purposes to be an abuse of the adequate provision requirement. In addition, the product labeling included in the information packet may not be nearly as visually stimulating as other enclosed materials and may get lost amid the gloss.170 In its current form, the technically-written product labeling likely will be ignored by the average consumer.171 The glossy pictures and colorful graphs that accompany the product, however, are informative about the product172 because direct mail advertising also is regulated and must include risk information in the glossy pages.173 In addition, promotional incentives are included in consumer packets sent in response to a request for product information.174

C. Improving Product Information Content
Clearly, one of FDA’s chief concerns, after ensuring consumer access to product
a questionnaire to help the consumer determine if he or she is suffering from a certain health problem or disease (see Letter from Migraine Resource Center, Glaxo Wellcome, to author (Mar. 15, 1998) (accompanying Imitrex® product information packet) (on file with author)); • a survey accompanied by prepaid postage envelopes (see Letter from Miles Jones, Senior Product Manager for Valtrex®, to author (Mar. 4, 1998) (accompanying Valtrex® product information packet) (on file with author) [hereinafter Valtrex® packet]); or • product discount coupons (see Valtrex® packet; Renova® packet; Letter from Mark Salyer, Director, Respiratory Products, Glaxo Wellcome, to author (Mar. 15, 1998) (accompanying Flonase® product information packet) (on file with author) [hereinafter Flonase® packet]). Product coupons may offer a $5.00 discount, for example, or a “free trial” of the drug. See Flonase®, packet supra. 168 The confidentiality of consumer information also is an issue for Internet websites. See Janet Carlson, Online Turn On: Reaching the Health-service Consumer, 32 MED. MKTG. & MEDIA 61, 61 (1997). Similarly, the required Internet websites also give manufacturers a promotional opportunity. A website visitor in search of product labeling information may be: • invited to enter a weekly give-away (see Schering Co., Allergy Relief Zone: Claritin®(visited Mar. 30, 1998) <http://www.claritin.com>); • offered product newsletter subscriptions (see Glaxo Wellcome, Migraine Resource Center: Imitrex® (visited Apr. 26, 1998) <http://www.imitrex.com> (offering free subscription to Headway, a newsletter for migraine sufferers)); or • product coupons (see Glaxo Wellcome, Welcome to Flonase.com: Flonase® (visited Mar. 30, 1998) <http:/ /www.flonase.com> (offering free nasal allergy kit, including $5 savings certificate, subscription to On the Nose newsletter, and information on products that treat nasal allergies)). Conversely, product websites may be useful as they may feature product labeling, disease information, and links to other health related websites. See infra note 183. See also Carlson, supra note 168, at 61 (describing consumer service health information websites). 169 Such claims, however, could not be related to the safety and effectiveness of the drug. See supra note 77 and accompanying text. For example, based on response to a consumer survey, a drug company may claim, “100,000 people have tried Nasalcort® and switched to Flonase®.” 170 See supra note 167. 171 See Sandulli, supra note 14, at 48 (“[e]ffective messages to consumers need to be simple and easily understood”). 172 For example, the product information packets for Imitrex® and Prilosec® contained disease-oriented informational brochures that educate the consumer about the disease or symptoms for which the product is prescribed. See supra note 167. 173 See supra notes 32-34 and accompanying text. 174 As noted, incentives include diaries, coupons, and questionnaires to help identify candidates for a drug. See supra note 167 and accompanying text. •

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labeling, is the usefulness of that labeling.175 As noted, FDA-approved product labeling is a technical document written for prescribing physicians and contains complex clinical pharmacology information and clinical trial results, and risk and adverse event information.176 Product labeling generally is considered inaccessible to the unsophisticated consumer.177 FDA encourages drug companies to provide consumers with nonpromotional, consumer-oriented product information in an attempt to satisfy consumer informational needs.178 In addition, FDA prefers that manufacturers disseminate FDA-approved product information, such as MedGuides and the patient product labeling required for oral contraceptives.179 Manufacturers, however, are not required to develop these patient-oriented materials for all prescription drugs and may not have them to disseminate.180 Hence, manufacturers may meet the letter of the adequate provision requirement by disseminating product labeling to consumers, but not the spirit of the requirement, which is to ensure consumers have access to information that they understand.181 To meet that need, manufacturers must provide more than the product labeling.182 Until FDA develops a policy addressing this issue manufacturers may continue to disseminate consumer information that FDA may consider to be far from “nonpromotional.”183 FDA, however, may not take issue with the promotional nature of product information disseminated under the adequate provision of labeling requirement, because such information may fulfill a currently unmet public health information need.184 As a precaution, FDA should monitor prescription drug broadcast advertising, the adequate provision of product labeling, and other forms of consumer product information.185
See supra notes 88-92 and accompanying text. Id. 177 Id. 178 See Draft Guidance, supra note 10, at 3; see supra notes 88-92 and accompanying text (regarding FDA MedGuide initiative to improve product labeling for consumers). 179 Draft Guidance, supra note 10, at 3. 180 See supra notes 88-92 and accompanying text. The need for nonpromotional information written for patients could provide additional support for expediting compliance or making mandatory the agency’s MedGuide initiative. See id 181 See Availability of Draft Guidance for Industry, 62 Fed. Reg. at 43,171. 182 See id; Draft Guidance, supra note 10, at 3 (suggesting that FDA recognizes the limits of promoting only the approved product labeling in response to requests for product information). 183 Industry’s attempt to meet consumer information needs has spawned the new trend of direct-to-patient (DTP) advertising, a kind of continuing medical education for consumers. See Jan Hodnett, supra note 110, at 95. DTP advertising is patient-oriented, although drug companies sponsor DTP materials and may refer to specific drug products. DTP advertisements tend to be more informational than promotional, dealing with general health and quality of life improvement topics. Publications like Headway (see HEADWAY, supra note 167 (Glaxo Wellcome, maker of Imitrex®) (containing information on headache triggers and testimonials); infomercials like Women Only: What To Do When Hair Gets Thinner (see Hodnett, supra note 110, at 94 (Roche, maker of Rogaine®)); and Internet websites educate consumers about specific diseases and symptoms, as well as treatments. See Allergy Relief Zone, supra note 109 (Schering Plough, maker of Claritin®) (featuring a monthly information newsletter, and offered to create a customized area for the web visitor to give customized information such as daily pollen counts in the area where the web visitor lives). See also Welcome to Flonase.com: Flonase ®, supra note 168 (visited Mar. 30, 1998) <http://www. flonase.com> (featuring a hypertext link to frequently asked questions about nasal allergies, answered by a prominent physician, as well as an offer to receive the company-sponsored allergy information newsletter On the Nose); The Cholesterol Medicine That Helps Save Lives: Zocor®, (visited Mar. 30, 1998) <http://www.zocor.com> (featuring a “risk factor” quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention); What You Should Know About First Heart Attack Prevention and Pravachol®, (visited Mar. 30, 1998) <http://www.pravachol.com> (featuring a “risk factor” quiz designed to give a personalized heart disease risk assessment as well as commonly asked questions about heart attack prevention). 184 See supra notes 88-95 for FDA’s concern about meeting consumer information needs. 185 This monitoring particularly should occur to ensure drug companies do not invent health problems and then provide a solution with their advertised prescription product. See, e.g., Wilke, supra note 10, at 1 (reporting on recent toenail fungus advertising campaign by Jannsen Pharmaceuticals).
176 175

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The Draft Guidance created more DTC marketing opportunities for drug companies than FDA probably intended. FDA sought to increase consumer access to prescription drug information, but instead may have increased drug companies’ access to consumers. FDA must examine its inadvertent grant of power to drug companies to reach consumers and ensure that power is not abused. Overall, the new Draft Guidance encourages companies to sponsor more health programming and to develop better consumer product information.186 This is a much-needed service as consumers require access to drug therapy information for adequate health care. Pharmaceutical companies, in effect, will contribute to the improvement of public health by helping to fill this informational void. In addition, in the present healthcare environment, a more knowledgeable consumer is a healthier patient. Information sponsored by drug companies may be promotional in nature, but drug companies operate in a for-profit, market-driven environment. As such, industry’s provision of health and prescription drug information is rarely undertaken as a public service, but as a promotional opportunity to increase market share. Allowing drug manufacturers this opportunity is a small price to pay for an invaluable information service, a more informed public health dialogue, and potentially healthier people. FDA should continue to permit the current adequate provision practices of drug manufacturers. FDA’s DTC advertising policy, or lack of policy, has been an information obstacle to consumers and the pharmaceutical industry for more than fifteen years. FDA’s long-awaited guidance clarifying the adequate provision requirement in broadcast advertising is an improvement that greatly enhances consumer access to prescription drug information.

186 As discussed, consumers need information on prescription drug therapy in light of managed care and restrictive drug formularies in order to ensure that they receive adequate healthcare services. Consumers’ prescription drug information needs currently are not met under the present framework. The new DTC broadcast advertising Draft Guidance for Industry will aid in improving consumer access to information. See supra notes 138-40, 147-55 and accompanying text. Though the product information delivered by drug manufacturers is promotional in nature, it can help fill the public health and drug information void. The product materials are consumer-oriented, so consumers are more likely to actually read and understand it.