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					                                                         Consumer Products
                                                                                                               Issue 6 Winter 2003

Court decisions, new and pending laws and regulations arise            The FTC, which has argued that claims of “washboard abs”
every day affecting companies that produce and market                  without exercise by these other companies are false, may
consumer products. Our Consumer Products Marketing                     well agree that the Ab Force is just as effective as the other
newsletter summarizes notable policy and regulatory                    belts; that is, none of them work. But while the marketers
developments, as well as court decisions, in the areas of              of Ab Force, unlike the other companies, do not expressly
consumer protection, Lanham Act, trademark, privacy,                   claim that their product will make you fit, their ads, the FTC
consumer product safety, and food and drug law. Our aim                argues, do leave the clear implication that purchasers should
is to keep you informed of these issues with a concise                 look for such results. As Howard Beales, the Director of the
overview of selected developments. Attorneys in all practice           Bureau of Consumer Protection, notes in the announcement
areas listed are available to answer any questions you may             of the Ab Force action, “There is no free ride on misleading
have in regard to any of these issues. To reach the editor             advertising. If you purposely evoke the false claims made
for any reason, contact                    for a similar product, then your ads are also deceptive. And
                                                                       you should expect to hear from the FTC.”
                                                                       Courtroom Evidence in FTC Consent Violation
The Truth Can Set You Back                                             Action

Clients often ask us what the FTC means by “implied                    The 6th Circuit recently affirmed a district court judgment
claims” and “how can a claim that is literally true get me             awarding the FTC $1.5 million in civil penalties for a consent
in trouble?” We’ve used various illustrations to answer                order violation. [U.S. v. Alpine Industries, Inc., 2003 WL
these questions over the years, but thanks to the FTC and              22232910 (6th Cir. Sept. 26, 2003).]
a company called Telebrands we now have the perfect
example.                                                        The case raises several noteworthy points. First, the FTC
                                                                has long taken the position that an advertiser must have
The FTC’s compliant against Telebrands alleges that the substantiation in hand before making a claim. [See, e.g.,
defendants ran ads for their Ab Force belts with images of FTC Policy Statement Regarding Advertising Substantiation.]
fit, lean women and muscular men using voiceover narratives However, in Alpine, the FTC conceded that in order to
with text like “I’m sure you’ve seen those fantastic electronic establish a violation of the consent order it was required to
ab belt infomercials on TV. They’re amazing! They’re the show that any substantiation proferred by Alpine was
latest craze to sweep the country and everybody wants one. insufficient and that experts were unaware of any other
The thing is, they’re expensive, selling for up to $120 each. scientific data supporting the claims.
That’s why we developed the Ab Force that you can buy
right now for just $10.” The narrator also says, “The Ab Second, clients will sometimes ask us about presenting the
Force is just as powerful and effective as those ab belts sold FTC with evidence showing a high level of customer
by other companies on infomercials.”                            satisfaction with the product or evidence as to the parties’

1.   Arnold & Porter’s Antitrust & Trade Regulation Group has extensive experience in consumer protection matters before the Federal Trade
     Commission (FTC), State Attorneys General, and the National Advertising Division (NAD). Members of our group include Bob Pitofsky,
     former FTC Chairman and Director of the Bureau of Consumer Protection; Mike Sohn, former FTC General Counsel; Bill Baer, former FTC
     Bureau of Competition Director; Debbie Feinstein, former Assistant to the FTC Bureau of Competition Director and Attorney Advisor; and
     Randy Shaheen and Amy Mudge who collectively have practiced in this area for over 20 years.
Arnold & Porter

intentions regarding the scope of the consent order.                     LANHAM ACT2
Although in our experience the agency is more likely to be
swayed by the latter rather than the former, the court made              OTC Drug Advertising May Face Heightened
it clear that neither type of evidence was relevant in the               Scrutiny
                                                               Procter & Gamble was hit with a preliminary injunction halting
365 Day Sale                                                   the following advertisement for its heartburn medication
                                                               Prilosec: “One pill. Twenty-four hours. Zero heartburn.”
While retailers often emphasize, in advertisements, that sale The problem – Prilosec does not begin working until five hours
prices are available for a limited time only, plaintiffs’ after ingestion. The court thought that Procter & Gamble
attorneys and California district attorneys have been should have made clear that Prilosec provides 24 hours of
emphasizing the same point in court. In August, the Napa relief only after the drug becomes “effective” hours later.
Superior Court issued an injunction and $1.2 million in civil The omission of this or similar qualifying explanations rendered
penalties against Kay-Bee Toy, Inc. The State of California the claim “literally false.” Onset of action is a competitive
argued that the chain advertised discounted “sale” prices, issue in this market, and the court commented that Prilosec
when the chain never, in fact, actually charged the regular is a relatively “slow acting drug” compared to other heartburn
price. The state also alleged that the chain ran price medications. In granting the preliminary injunction, the court
comparison advertisements in which the Kay-Bee price was made two noteworthy comments: the court suggested that
compared to prices of competitors, not in the region where advertising claims for over-the-counter medications will be
the advertisement appeared, but in distant parts of the subject to higher scrutiny than will ads for Rx drugs: “a
country.                                                       manufacturer selling a drug over the counter ought to be
                                                               more punctilious and more careful in conveying a false
Kay-Bee also settled a class action lawsuit brought under message than a manufacturer selling a drug which is
the Consumer Fraud and Deceptive Practices Acts of Illinois prescribed only under the care of a doctor.” Second, the
and a number of other states. These acts – so called “Baby court thought that plaintiff’s showing of irreparable harm
FTC” acts – seek to protect state consumers against unfair was stronger because the challenged advertising related to
and deceptive practice and are generally similar to the FTC a “new product launch, a time when the buying public is
Act in their requirements. The Illinois suit alleged conduct particularly attentive and educable.” [Johnson & Johnson-
similar to that charged in the California case and settled for Merck Consumer Pharma. Co. v. Procter & Gamble Co.,
$4 million – one million in attorneys’ fees and a $3 million 2003 WL 22227962 (S.D.N.Y. Sept. 25, 2003).]
settlement fund. In an interesting twist, the settlement fund
was distributed by means of an unadvertised one week 30% “Matter-Of-Opinion” Defense May Depend Upon
off sale in mid-October.                                       Intent

Try TiVoing This                                               In false advertising litigation, expressions of “opinion”
                                                               generally are not actionable because an opinion cannot be
Commercial Alert, an Oregon-based public interest group proven to be true or false. However, simply phrasing an
with Ralph Nader, among others, on its board of advisors, advertising claim as an “opinion” (or characterizing the claim
has petitioned the FTC to establish guidelines relating to the as “opinion” for purposes of litigation) does not immunize the
increasingly prevalent practice of product placement on claim. Recently, a Michigan court held that a “matter-of-
television. The petition argues that current disclosures of opinion” defense turned on factual issues regarding the
product placement, which often occur at the end of a show, speaker’s intent, precluding summary judgment. The
are not adequate and that instead “product placements should defendant was sued for sending a letter to its customers
be identified when they occur” as well as at the outset of a asserting that the defendant was entitled to license a certain
program. In making its request, Commercial Alert argues plastic injection molding technology notwithstanding pending
that children are especially vulnerable to product placements patent litigation. In moving for summary judgment, the
and seeks to build on the FTC’s directive to Internet search defendant argued that its letter reflected an inactionable
engines that they provide “clear and conspicuous “opinion as to the present state of legal affairs in the parties’
disclosures” to distinguish paid placements from actual ongoing and as-yet-unresolved dispute.” Rejecting this
search results.                                                argument, the court held that the author’s intent in writing

2.   Arnold & Porter attorneys have significant experience with Lanham Act deceptive advertising counseling and representing both plaintiffs
     and defendants in deceptive advertising litigation. The firm has represented companies and advertising agencies in diverse product
     areas (including some seminal cases in the pharmaceutical sector) and has handled both literal-falsehood cases and implied-falsehood
     cases, which require scientifically designed surveys. Attorneys in the firm with Lanham Act experience include Joel Freed, Chuck
     Ossola, Helene Madonick, Suzy Wilson, Randy Shaheen, and Randy Miller.

                                                                                 Consumer Products Marketing Winter 2003

the letter was a disputed material fact that precluded                    Extensions of Time for Opposition. While it formerly was
summary judgment. “Perhaps defendants can produce                         possible, with the consent of the applicant, to extend the
sufficient evidence” to indicate that the author of the letter            time for filing an opposition to registration of a mark without
“was expressing a tenable personal belief.” “Alternatively,               any time limit, under the new rule the time for filing an
plaintiff might persuade the trier of fact that [the author of            opposition cannot be extended beyond 180 days. The old
the letter] sought to mislead his readers.” [Plastic Molded               rule will continue to apply where the first request for an
Tech., Inc. v. Cinpres Gas Injection Ltd., 2003 WL 22481209               extension of time was filed before November 2. Where the
(E.D. Mich. Oct. 22, 2003).]                                              first request is filed on or after November 2, though, the
                                                                          new rule applies.
Court Enforces False Advertising Settlement
Agreement                                                       Revival of an Abandoned Application. Under the old rules,
                                                                an applicant who checked on the status of the application
In Building Materials Corp. of Am. v. Certainteed Corp., 273 within one year of filing the application or another paper
F. Supp. 2d 552 (D.N.J. 2003), competitors had settled a during prosecution was considered diligent. Under the new
prior Lanham Act false advertising suit involving attic rule, the applicant must check on the status at least every
ventilation products by conditioning the order of dismissal on six months to be considered diligent. The rule governing the
a settlement agreement. The plaintiff subsequently brought filing of petitions to renew is otherwise unchanged.
a new action and obtained an order enjoining the competitor’s
advertising on the grounds that the claim violated the parties’ Also note that the rules governing the form of drawings have
settlement agreement. This case is a reminder that a changed.
settlement agreement can be an effective tool in establishing
advertising rules going forward. Competitors can use a                    Registration of Geographic Terms
settlement agreement to identify certain advertising claims
as false and insulate other claims as fair game. Then, as in              The Federal Circuit’s trademark docket has been unusually
Building Materials, a suit to enforce the settlement agreement            full this year with 16 cases decided so far. Two of these
is governed by breach of contract principles, which can be                cases highlight a substantial and surprising change in the law
more straightforward than renewed Lanham Act litigation.                  governing registration of geographic terms as marks.
In particular, violations do not depend upon complex proofs
– such as survey evidence or scientific testing – to              Before NAFTA, an application to register a geographic term
demonstrate that an advertising claim is false. In this respect,  could be rejected under 15 U.S.C. 1052(a) if the term was
settlement agreements can eliminate some of the costs and         “deceptive.” Such marks could never be registered on either
uncertainty of future deceptive advertising litigation.           the principal or supplemental registers. In addition, under
                                                                  15 U.S.C. 1052(e), a mark that was primarily geographically
TRADEMARK         3                                               descriptive or a mark that was “primarily geographically
                                                                  deceptively misdescriptive” could be denied registration on
New Trademark Registration Rules                                  the principal register. Marks denied registration on the
                                                                  principal register under 1052(e) though, were generally
In our Spring 2003 issue, we noted that the Senate had eligible for registration on the supplemental register, and,
consented to U.S. accession to the Madrid Protocol. The upon a showing that they had acquired distinctiveness, such
Patent and Trademark Office has now issued its final rules marks could be moved to the principal register.
implementing the Protocol, and they take effect this year on
November 2. At the 11th hour, the PTO rescinded the The standard for testing whether a mark was deceptive under
requirement that all Protocol filings be done electronically. 1052(a) was more stringent than the standard for testing
For now, the PTO will accept only paper filings. It is unclear whether a mark was “primarily geographically deceptively
when their electronic systems for Protocol filings will be ready. misdescriptive” under 1052(e). The PTO denied registration
                                                                  under 1052(a) only when it was shown that a geographically
More broadly, a number of the rules, including two of special “deceptive” term would materially affect the public’s decision
interest noted here, apply not just to applications under the to purchase the goods. A mark containing a term which
Protocol for international trademark protection, but to all was “primarily geographically deceptively misdescriptive”
trademark filings with the PTO.                                   could be denied registration on the principal register under

3.   Arnold & Porter has extensive experience in all areas of trademark and domain name law, including emerging issues in the areas of federal
     dilution law and nominative fair use over the Internet. Some members of the group include, in our DC offices: Jim Walsh (former
     Administrator for Trademark Policy and Procedure at the PTO), Joel Freed, Roberta Horton, Chuck Ossola, and Mike Songer, and in our
     LA offices: Suzy Wilson, Ron Johnston, and Jim Blackburn.

Arnold & Porter

1052(e), when the place in question was merely “connected”                 mental pause was required to comprehend that the phrase
with the goods. It was not necessary under 1052(e) to show                 describes golf-style clothing for babies. As a result, the court
that any association between the goods and the place was                   upheld the board’s refusal of registration.
material to the consumer’s purchasing decision. Because
showing the materiality of a misdescriptive mark to purchasing  In In re MBNA America Bank, N.A., 340 F.3d 1328 (Fed.
decisions is difficult, it was much easier for the PTO to deny  Cir. 2003), the court similarly rejected MBNA’s claim that
registration under 1052(e) than under 1052(a). At the same      geographic terms like “Montana Series” and “Philadelphia
time, though, a mark denied registration under 1052(e) might    Card” do not convey information about MBNA’s credit card
eventually be placed upon the principal register after acquiringservices and were, therefore, suggestive or arbitrary. The
distinctiveness.                                                court upheld the Board’s finding that MBNA was not merely
                                                                providing financial services, but attempting to create a service
Under the NAFTA and TRIPS agreements, however, it was that satisfies a “social or lifestyle association with a particular
presumed that the United States would be required to make city or state.” As such, the terms were merely descriptive
it “easier” to prevent registration and use of geographic terms of the service that MBNA sought to create. These decisions
that connect the goods with a place other than their actual may suggest that the PTO and Federal Circuit will be taking
place of origin. As a result, section 1052(e) was amended to a more expansive view of what is “merely descriptive” for
preclude registration of “primarily geographically deceptively registration purposes.
misdescriptive” marks entirely. Under the amended section
1052(e), a mark that is primarily geographically descriptive
can still be placed on the primary register following a showing PRIVACY

of distinctiveness. A mark that is geographically deceptively
misdescriptive, however, cannot.                                Fair Credit Reporting Act Amended to Preempt
                                                                           State Law
Paradoxically, in its first case interpreting the amended
section 1052(e), though, the Federal Circuit may well have                 During the final days of the 2003 Congressional session, the
made it easier, not harder, for “primarily geographically                  Senate and the House finally reached agreement on an
deceptively misdescriptive” marks to be registered, reasoning              extension of the state law preemption provisions of the Fair
that because the consequences of a denial of registration of               Credit Reporting Act (FCRA), which were due to expire as
a trademark under 1052(e), like a denial under 1052(a), are                of December 31, 2003. By an overwhelming margin in the
now absolute and that the focus is now on deceptive marks,                 House and unanimous consent in the Senate, Congress made
the Federal Circuit imported the materiality test from 1052(a)             those preemption provisions permanent as part of a new “Fair
into the test for 1052(e). It is now necessary, under both                 and Accurate Credit Transactions Act of 2003.” The new
provisions, to show that the geographical “misdescription”                 legislation not only provides for comprehensive federal
materially affects consumers’ decisions to purchase the                    preemption of state law with respect to credit-related
goods. [In re California Innovations, Inc, 329 F.3d 1334                   information, but also requires extensive new protections of
(Fed. Cir. 2003).] In a subsequent case the Federal Circuit                consumer information to prevent identity theft.
applied the same materiality consideration to service marks.
[In re Les Halles De Paris J.V., 334 F.3d 1371 (Fed. Cir.     For most financial institutions, the final legislation represents
2003).]                                                       a very significant victory in the effort to avoid regulation
                                                              under a myriad of different state privacy laws. Under the
Flight from Fancy                                             new FCRA, complete federal preemption will exist with
                                                              respect to all of the following activities: sharing of “consumer
Following a trend observable in lower courts for some time, report” information with company affiliates, prescreening
the Federal Circuit, in two cases decided this term, rejected consumers for purposes of making firm offers of credit or
arguments that an “imaginative leap” was required to discern insurance, providing consumers with notices of “adverse
the meaning of the marks and found them merely descriptive. actions” based on credit report information, and consumer
In In re Dayan, 61 Fed. Appx. 695 (Fed. Cir. 2003), the access to and the correction of errors in consumer reports.
court held that the phrase “Baby Golf” as applied to golf In addition, following a heated debate with respect to state
clothing for babies was not incongruous because the image protections against identity theft, the final FCRA amendments
of babies playing golf or wearing shoes with cleats was a also preempt state law with respect to those protections as
fanciful notion. The court concluded that no imagination or well.

4.   Arnold & Porter’s Privacy Team provides legal and strategic counsel to help clients meet their privacy obligations in a demanding, evolving,
     and competitive marketplace. Our attorneys have held significant senior government positions, including John Bentivoglio, former Chief
     Privacy Officer of the DOJ; Jeff Smith, former General Counsel of the CIA; Bob Pitofsky, former Chairman of the FTC; and Ron Lee,
     former General Counsel of the National Security Agency. Others with extensive experience in this area include Nancy Perkins in our DC
     office, Gregory Fant in our LA office, and Sarah Kirk in our London office.

                                                                                Consumer Products Marketing Winter 2003

The final legislation does impose new burdens on companies               and the required studies would address some of the disputed
that seek to share consumer report information with their                issues, such as whether credit scores may reflect any unfair
affiliates, however, when the purpose of such sharing is to              discrimination against particular groups.
facilitate marketing by the affiliate(s). Currently, a company
may, without subjecting itself to the rules applicable to                The requirement for new FCRA regulations promises continued
consumer reporting agencies, share credit report data on an              development of standards for the use of consumer credit-
individual with its affiliates so long as the individual has the         related information at the federal level. But the challenges
opportunity to opt out of such sharing. Under the new                    for industry with respect to such federal regulations are a
amendments, companies will be able to do this for marketing              welcome trade-off for the relief from dealing with state-by-
purposes only if the consumer is explicitly informed about               state – as well as individual localities’ – rules on sharing,
the intended uses of the information for marketing by                    decision making, and related activities involving consumer
affiliates. Further, an affiliate receiving such information             report data.
will be directly prohibited from using the information for
marketing purposes unless the opt-out requirements have                  CONSUMER PRODUCT SAFETY5
been complied with. In a last-minute compromise favorable
to the industry, it was agreed that a consumer’s decision to             Senate Moves to Lift Cap on CPSC Civil Penalties
opt out of such sharing will expire after five years, requiring
a new exercise of the opt-out right in order to prevent such     Over the past several years, the dollar value of civil penalties
sharing thereafter. In addition, language generally favorable    sought by the U.S. Consumer Product Safety Commission
to industry was agreed to on an exemption from the opt-out       (CPSC) against companies for failing in a timely fashion to
requirements for affiliate marketing, which allows sharing       report alleged product hazards to the CPSC, as required by
of information with affiliates that have a “pre-existing         the Consumer Product Safety Act (CPSA), and for distributing
business relationship” with the consumer whose information       products that violate mandatory standards, has increased
will be shared.                                                  significantly. Apart from a recovery of liquidated damages
                                                                 in one case, CPSC first recovered a civil penalty of at least
The new identity theft provisions require credit-reporting $750,000 in August 2000. However, since that time, CPSC
agencies to include, at the request of a consumer, a fraud has settled 10 other civil penalty matters for between
alert in the consumer’s credit file. Reporting agencies will $750,000 and $1.3 million. That upward trend could
be required to notify those procuring credit reports of the skyrocket under proposed legislation passed by the Senate
fraud alert, and companies using credit reports where a fraud to raise the maximum civil penalties for violations of the
alert has been issued will have to obtain authorization from CPSA. The Senate passed the Consumer Product Safety
the consumer by the method specified in the alert before Commission Reauthorization Act of 2003 which would amend
extending credit. In addition, companies will be prohibited the CPSA to increase the maximum civil penalty from $1.65
from printing more than the last four digits of a credit card million to $20 million for a “related series of violations” of
number on any electronically generated credit card receipt. the Act. [See S. 1261, 108th Cong. § 6 (2003).] The
Importantly for consumer protection advocates, consumers proposed legislation has been referred to the Committee on
will have the right to receive one free credit report each Energy and Commerce in the House of Representatives.
year, as well as to have access to their credit scores created
by consumer reporting agencies.                                  The proposed increase in the maximum civil penalty supports
                                                                 the view of CPSC Commissioner Thomas Moore, who
The new legislation calls for a number of studies, as well as recommended during a Senate Subcommittee hearing that
the adoption of regulations by the federal banking agencies the civil penalty cap should be eliminated altogether.
and the Federal Trade Commission with respect to entities Commissioner Moore said that a $1.65 million fine “means
subject to their respective jurisdictions. The studies to be nothing” to the corporations regulated by the CPSC, and that
conducted include analyses of company practices with “the potential leverage of an unlimited potential for fining”
respect to sharing consumer information and an evaluation would be important to the Agency. CPSC Chairman Hal
of how the use of credit scores and credit-based insurance Stratton and Commissioner Mary Sheila Gall, however,
scores affects the availability and affordability of financial expressed some concerns with the proposal; they both cited
products and services. Reliance on credit scores as to the CPSC’s need for additional resources to meet the fight
determinants of eligibility for credit or insurance has become that companies could be expected to mount to defend against
increasingly controversial, including in the litigation context, a possible $20 million penalty.

5.   Arnold & Porter has several attorneys with broad experience on matters involving the U.S. Consumer Product Safety Commission,
     including two former General Counsels of the agency – Eric Rubel and Jeff Bromme – and Blake Biles, formerly with the Environmental
     Protection Agency. We take a proactive approach to product safety issues, assisting clients to establish and audit internal controls. We
     represent clients in CPSC enforcement actions, as well as in private litigation that can result from CPSC matters.

Arnold & Porter

Whether CPSC would seek to impose substantially greater                  In the Caputo case, the government sought to use the
civil penalties if the legislation passed by the Senate ultimately       defendant’s off-label promotion as evidence to support
becomes law remains uncertain. Indeed, some critics of                   prosecution for statutory violations, and the defendants argued
raising the cap note that an increase is unnecessary because             that the government’s use of off-label promotion violated the
CPSC still has not assessed a penalty of $1.65 million, which            First Amendment. The Caputo holding is significant because
is the cap under current law. However, the potential                     the court ruled that the First Amendment may not protect a
increased exposure to manufacturers, importers, distributors,            company from liability for off-label promotion.
and retailers for violations of the CPSA and related
requirements if the cap is lifted warrants close attention.              For a more detailed analysis of the Caputo case, visit our
                                                                         website at
FOOD AND DRUG6                                                           First_Amendment_Not_Defense.PDF

Court Rules That First Amendment is Not Absolute State Governments Continue to Crack Down on
Defense to Off-Label Prosecution                 Internet Advertising and Sale of Prescription Drugs

The District Court for the Northern District of Illinois ruled           The Oregon Attorney General filed a lawsuit at the end of
that the First Amendment does not provide an absolute                    October against two medical doctors alleging unlawful sale
defense against prosecution based on a manufacturer’s                    and advertising of prescription drugs on the Internet in violation
promotion of off-label use of a medical device. [United States           of state consumer protection laws. The FDA’s Office of
v. Caputo, 2003 WL 22431547 (N.D. Ill. Oct. 21, 2003).]                  Criminal Investigation provided significant assistance with the
The court found that prohibiting the FDA from proscribing                investigation. Defendant doctors allegedly unlawfully promoted
manufacturer promotion of off-label uses would “severely                 Human Growth Hormone, illegally sold free samples of
frustrate the FDA’s ability to evaluate the effectiveness of             prescription drugs, and falsely claimed a female arousal cream
off-label uses,” and that it was unable to identify a less               contained the same active ingredient as Viagra. Additional
burdensome alternative. If the regulations were struck down,             information is available on the Oregon Attorney General
the FDA’s evaluation process would be compromised because                website at
“[m]anufacturers, knowing that they could promote off-label
uses, would have an incentive only to seek FDA approval for
                                                        FDA Proposes Steps to Assure the Safety and
those uses that would be approved easily and inexpensively.”
                                                        Efficacy of Certain Unapproved but Widely
The court agreed with the reasoning in Washington Legal
                                                        Marketed Medicines
Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998),
vacated by Washington Legal Foundation v. Henney, 202                    The FDA issued a draft Compliance Policy Guide for proposed
F.3d 331 (D.C. Cir. 2000), but came to a different conclusion.           new steps to encourage companies to sponsor for approval
The district court in Washington Legal Foundation had struck             medicines that were developed and marketed before the
down on First Amendment grounds FDA policies concerning                  establishment of modern standards for drug approval. Some
distribution of peer-reviewed journal articles and sponsorship           doctors continue to prescribe these drugs because, based on
of medical education seminars promoting off-label use. The               anecdotal evidence or longstanding use, they are believed to
court in that case had enjoined the FDA from enforcing the               be safe and effective for certain uses. The draft policy would
policies, which it found were more extensive than necessary,             give the highest priority for FDA enforcement action to those
because “permitting this limited form of manufacturer                    products which pose the most likely risk to public health,
communication still leaves more than adequate incentives                 either because of inherent safety concerns about the drugs,
compelling drug manufacturers to get new uses approved by                or because there are alternative treatments available that
the FDA.” The D.C. Circuit vacated the injunction for lack               have been shown to be safe and effective.
of a case in controversy, but noted the possibility that a
manufacturer “may still argue that the FDA’s use of a                    The FDA is seeking public comment on the draft Compliance
manufacturer’s promotion of off-label uses as evidence in a              Policy Guide published on its website at
particular enforcement action violates the First Amendment.”             cder/guidance/5704dft.pdf.

6.   Arnold & Porter’s Food, Drug and Medical Devices Group has represented a variety of companies in responding to inquiries from FDA and
     other agencies about advertising claims and other marketing activities, as well as worked on complaints to FDA and others regarding
     apparently violative conduct by competitors. Members of the group in our DC office include Bill Vodra, Arthur Levine, and Don Beers,
     each of whom previously were prominent lawyers at FDA, Helene Madonick, Rob Conley, and David Korn.


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