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Executive Summary

An FDA working group is evaluating the appropriateness of consumer ads promoting aspirin for the prevention of second heart attacks. The group has reportedly met at least three times since the industry's voluntary agreement to halt aspirin advertisements for the prevention of first heart attacks in early March ("The Pink Sheet" March 7, pp. 3-4). The working group, headed by FDA Executive Assistant to the Commissioner Joseph Levitt, is comprised of roughly a dozen FDAers, including staff from the Commissioner's office, the Office of Compliance and the Office of Drug Standards, which oversees drug advertising. According to agency officials, the working group also includes staff from relevant drug review divisions -- presumably the Division of Cardio-Renal Drug Products and the Division of Gastrointestinal and Coagulation Drug Products. The agency's concern over aspirin ads for the prevention of second heart attacks, a claim approved for professional labeling, appears to have been prompted by the recent ads for the unapproved claim of prevention of first heart attacks. Among the issues reportedly being discussed by the working group is whether, after the wave of the publicity on the Physicians Health Study of aspirin use for prevention of first heart attacks, consumers will be able to differentiate promotions of the second heart attack prevention claim from press reports on the first heart attack study results. Consumer advertisements discussing the prevention of second heart attack have been running for over two years without any formal objections from FDA. Sterling was the first company to run ads after FDA approved the professional labeling claim in October 1985. The company began print ads for Bayer aspirin in early 1986 and television ads in 1987 informing consumers that aspirin, as prescribed by a physician, has helped prevent second heart attacks. Consumer ads for Bristol-Myers' Bufferin and Rorer's Ascriptin have also run. Although FDA has not taken any action against firms for promoting the second heart attack claim to consumers, FDA regulations, according to the Office of Compliance, prohibit consumer ads for professional labeling claims of OTC products. However, at the March 3 press conference to announce that aspirin manufacturers had agreed to discontinue ads for the prevention of first heart attacks, FDA Commissioner Young implied that the issue with the first heart attack ads related primarily to the fact that the claim had not yet been approved. Young also emphasized that the Federal Trade Commission has regulatory jurisdiction over OTC advertisements, but that FDA would consider a product mislabeled "if adequate directions for safe use are not provided for uses for which the drug is promoted." FTC Bureau of Consumer Protection Director William MacLeod also told the press conference that FTC's objections to the ads were based on the fact that the first heart attack claim was "unsubstantiated." According to FDA officials involved in the aspirin issue, the working group is still evaluating its position on the ads for prevention of second heart attack. However, the agency may have tipped its hand on this issue with its recent regulatory letter to Sterling. In that March 30 letter, FDA told Sterling that Bayer aspirin calendar paks were misbranded because the product's labeling and packaging "represent and suggest to the consumer that 'Genuine Bayer Aspirin' is useful in the prevention of heart attack" ("The Pink Sheet" April 4, T&G-1). While the agency did not differentiate between claims for first and the second heart attack, the letter noted that the company was told in 1985, when the second heart attack indication was approved, that the claim could "be provided to health professionals only and not to the general public," and that it "may not appear on OTC aspirin products."

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