During 1998, the Food and Drug Administration continued its policy of monitoring on-line advertisements for prescription drugs and vigorously pursued advertising restrictions on off-label uses.¹ In the midst of its anti-advertising policies, the FDA did go forward with one measure moderately favorable to advertisers: its direct-to-consumer advertisement policy that gives drug makers more freedom in broadcast advertising of prescription drugs. Meanwhile, the U.S. Court of Appeals for the Second Circuit ruled in 1998 that it will permit the FDA to continue its restrictions on health claims made on dietary supplements.

On-Line Enforcement

   The FDA is monitoring the Internet to check the content of prescription drug advertisements. In October 1996, the FDA held a public meeting to consider the views of consumers, patient groups, health professionals, and manufacturers of FDA-regulated products regarding how the FDA should regulate prescription drug information disseminated over the Internet. Also in 1996, the agency requested written comments on some of the same Internet-related drug promotion issues. In 1998, the FDA announced that it is considering the written comments as well as suggestions made by the meeting participants, and that it plans to publish a draft guidance to clarify its policies.

Direct-to-Consumer Advertisement Policy

   In August 1997, the FDA issued a Draft Guidance for Industry to clarify its position regarding direct-to-consumer advertisements for human and animal prescription drugs. The FDA requires all prescription drug broadcast advertisements (i.e., all advertisements that contain both a drug's name and a description of the drug's uses) to provide a "major statement" about the risks of the advertised drug. In addition to the major statement, the FDA mandates that the advertisement contain a brief summary of the drug's side effects, contraindications, and effectiveness. The FDA provides an alternative to its "brief summary" requirement by permitting advertisers to make adequate provision for dissemination of the product's approved labeling.

   Before 1997, advertisers were unsure of what the FDA's "adequate provision" regulation required and were unwilling to provide "adequate provision" in their advertisements for fear they would violate the FDA's rules. Because including a brief summary of the product's approved labeling was burdensome, advertisers rarely mentioned both a drug's name and its purpose in a broadcast advertisement.

   The FDA's 1997 draft guidance clarified the meaning of "adequate provision" and paved the way for advertisers to use both a drug's name and its purpose in broadcast advertisements. Although the guidance is helpful in that it expands advertising options, it nevertheless imposes substantial burdens on advertisers who take advantage of its provisions. For drug companies to comply with the FDA's "adequate provision" regulation, they must ensure that their advertisement contains a toll-free telephone number that consumers can call to request the FDA-approved package labeling, a reference to print advertisements about the product in consumer magazines or brochures so that consumers can read more detailed drug information, a statement that additional product information is available from a doctor or pharmacist, and an Internet address where consumers can find package labeling.

   The FDA accepted comments on its draft guidance through October 1997. The agency has not made public its analysis of those comments nor stated when it will release a final guidance for industry.

Restrictions on Information About Off-Label Drug Uses²

   In July 1998, a federal district court in the District of Columbia handed a victory to the Washington Legal Foundation (WLF) in its First Amendment challenge of the FDA's restrictions on speech concerning so-called "off-label" uses of prescription drugs and medical devices. Washington Legal Foundation v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998).

   WLF filed suit in 1994 asking the district court to strike down FDA guidances that barred manufacturers from helping to disseminate professional articles, textbooks, and presentations addressing uses for their products that the agency had not approved - even though the speech originated with scientists and doctors who had no financial ties to the manufacturer. The agency fought back initially on procedural grounds. Among other arguments, it contended that the challenged matters were not "ripe" for review because the agency had not formally adopted the guidances. The judge dismissed the agency's ripeness argument and ordered the suit to proceed, noting that FDA officials had warned manufacturers as early as 1991 to "put their advertising and promotional houses in order" in accordance with the FDA's proposals - while also telling the court that the agency needed more years to deliberate before taking final action on the guidances.

   In July 1998, the district court granted WLF's motion for summary judgment and enjoined the FDA from restricting speech concerning off-label uses. The court held that the FDA's guidances limit speech as opposed to conduct. It also ruled that the speech in question is extensively regulated commercial speech rather than fully protected speech. Applying the commercial speech test of Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980), the court found that the government's interest in regulating speech about off-label uses is substantial and that the regulations directly advance the government's interest in requiring manufacturers to submit supplemental applications to obtain approval for new uses.

   Nonetheless, the court found the regulations unconstitutional because they are more extensive than necessary. Based upon its holdings, the court enjoined the FDA from prohibiting, restricting, sanctioning, or otherwise seeking to limit any pharmaceutical manufacturer from disseminating to medical professionals any generally available reference textbook or previously published article concerning prescription drugs. The FDA has moved to clarify the court's order, and this motion is still under the court's consideration.

   Despite its loss in district court, the FDA promulgated final rules restricting speech concerning off-label uses in November 1998. The regulations implement Section 401 of the Food and Drug Modernization Act (FDAMA). FDAMA permits manufacturers of marketed drugs, biologics, and devices to disseminate certain written information regarding the safety, effectiveness, or benefits of an off-label use. The FDA argues that the Washington Legal Foundation decision does not impair the agency's ability to restrict speech in its regulations, but merely prohibits the FDA from restricting speech through its guidances. WLF contends that the court's opinion applies to more than simply FDA guidances; it also applies to the FDA's long-standing policy of restricting speech. According to WLF, the Washington Legal Foundation decision establishes the constitutional line at which speech must be protected, and the FDA's FDAMA regulations cross the line. This matter is sub judice.

   If the new regulations remain, they will have the following effect. Sixty days before a manufacturer disseminates information, it must submit to the FDA, among other documents, the information to be disseminated, any accompanying clinical trial information, and a detailed supplemental application for new use. After examining the submission, the FDA may choose several courses of action. These include prohibiting the manufacturer from disseminating the information, requiring the manufacturer to meet with the FDA, or requiring the manufacturer to maintain records that will identify individual recipients of the information to be disseminated.

   Moreover, off-label use information could be distributed in certain forms only: in an unabridged reprint or copy of an article, or in an unabridged reference publication. The information must not pose a significant risk to the public health, and it must not be false or misleading or derived from clinical research conducted by another manufacturer unless the other manufacturer has consented to the information's use. The information must be accompanied by a mandatory statement warning the reader that the information concerns a use that the FDA has not approved.

Regulation of Health Claims Made on Dietary Supplements

   At least one court of appeals was unwilling to provide advertisers with legal relief from the FDA's labeling restrictions. In Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d Cir. 1998), the U.S. Court of Appeals for the Second Circuit held that a facial First Amendment challenge to the Nutritional Labeling and Education Act (NLEA) was not ripe for review. The suit was brought by a nonprofit association of consumers, health professionals, and natural product retailers and manufacturers. The plaintiffs argued that NLEA's requirement that persons wishing to make health claims on labeling of dietary supplements petition the FDA for authorization constituted a prior restraint of lawful speech.

   The regulations state that the FDA will permit health claims to be made only when "there is significant scientific agreement ... that the claim is supported by [scientific] evidence." Id. at 223. If the FDA finds that a proposed nutrient-disease relationship is supported by significant scientific evidence, it will promulgate a regulation authorizing claims to be made about the relationship. If the FDA determines that no substantial scientific agreement exists, it will not permit the claim to be made on the label. The Second Circuit refused to consider the merits of the plaintiffs' charge, stating that they could not bring a preenforcement facial First Amendment challenge to the NLEA and its regulations. The court was not swayed by the fact that the plaintiffs may have to wait up to 540 days after they file a nutrition label application with the FDA to obtain a final decision.