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Executive Summary

FDA's anticipated proposed policy on direct-to-consumer advertising of prescription products is expected to include the establishment of a board of review comprised of representatives from FDA and the Federal Trade Commission. The idea for such a review board was first floated last summer in an FDA draft policy statement on direct-to-consumer ads, which is expected to serve as the basis for published regulations on agency ad policy. The draft policy proposal, which was sent by Center for Drug Evaluation and Research Director Carl Peck, MD, to then-Acting Commissioner James Benson on July 17, 1990, outlined the concept of the FDA/FTC review board. FDA is understood to still be considering the concept. Collaboration between FDA's ad division staff and the FTC is growing. Earlier this year, FDA ad division staffer Lou Morris began working at the FTC two days a week on developing consumer perception tests for evaluating OTC drug ads. The year-old direct-to-consumer ad policy document states that a "board may be established to review proposals and advertisements on an ad hoc basis to determine whether they meet" the criteria of a two-tiered review process. The proposed policy notes that "representatives from within the FDA and other federal agencies (i.e., the Federal Trade Commission), may be included on the board." In addition, the board "could use as consultants experts in consumer behavior, marketing research and other pertinent fields as each case warranted." In reviewing product-claim ads, the proposal says, FDA will want to determine whether there is "evidence that: 1) the message to the consumer cannot be conveyed by help-seeking advertisements, and 2) that the proposed consumer advertisement presents needed information in a balanced, understandable, and otherwise non- misleading manner." FDA's concern with direct-to-consumer ads is focused primarily on product-claim ads. "Because consumers lack medical training, the FDA believes that [product claim ads] directed to consumers are much more likely than physician-directed ads to be false or misleading." The ad policy reportedly is still being refined at the upper levels of FDA. FDA Commissioner Kessler has made assurances that other ad guidances will be published this year, including guidances on industry-sponsored symposia and press release/VNR promotions. However, he has been quiet on direct-to-consumer ads except to question whether such ads are a legitimate promotional avenue for prescription drugs ("The Pink Sheet" March 4, p. 3). Although the ad policy has not been made public, industry is already submitting comments on the proposal. In a June 14 citizen petition, D.C. law firm King & Spalding asked FDA not to adopt the proposed policy because it would mandate preclearance of direct- to-consumer prescription ads ("The Pink Sheet" July 1, p. 12). Also concerned about the proposed policy, 3M Pharmaceuticals sent a letter in June to the agency requesting that the policy recognize "patient preference" features in direct-to-consumer ads as being valuable in helping patients make a choice between products. The agency says it "intends to promulgate regulations requiring prior approval of" direct-to-consumer ads. The regs are expected to be promulgated when the agency makes public its direct-to-consumer ad policy. FDA currently asks firms to seek agency review before running such ads. The proposed policy will require company's planning product- claim advertising for prescription drugs to "present evidence that may include review of medical, public health and other scientific literature as well as methodologically appropriate consumer testing." Before beginning consumer testing, the proposed policy suggests that companies submit a proposal for consumer ads to "obtain an agency determination that the circumstances warrant further testing." Compliance with the policy's ad review requirements will be diligently enforced by FDA, according to the proposal. "If a firm has failed to have the agency review its ad prior to publishing it, the agency may take immediate regulatory action without first issuing warnings in the form of a regulatory letter."

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