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FTC EVALUATION OF ASPIRIN ADS FOR PREVENTION OF SECOND HEART ATTACKS

Executive Summary

FTC EVALUATION OF ASPIRIN ADS FOR PREVENTION OF SECOND HEART ATTACKS is focusing on whether the message of the ads has changed since publication of the Physicians Health Study on use of aspirin for prevention of first heart attacks, Federal Trade Commission Division of Advertising Practices Associate Director Lee Peeler told the Food & Drug Law Institue Nov. 30. "We are looking very closely at all of the [aspirin] ads" for prevention of second heart attacks, Peeler said. In reviewing those ads, "the question that the FTC has had to face is: Has the advent of the Physicians Health Study somehow changed the context of those ads and are we seeing different ads now?" FTC's investigation is also examining the extent to which the aspirin ads advise consumers to see their doctors before beginning a daily regimen of aspirin for prevention of second heart attacks, Peeler said. "I think that when you look at professional labeling and what professional labeling is, one of the conclusions that you come to fairly inescapably is that advertisements for those types of uses should have very clear directions to the consumer not to begin these types of regimens unless they are advised to do so by a physician," Peeler continued. "We are looking right now at how clearly existing [aspirin] ads convey those types of limitations." The evaluation of the aspirin ads for prevention of second heart attacks, an approved professional labeling claim, was initiated after publication of the Physicians Health Study in January. Although aspirin manufacturers voluntarily agreed to discontinue ads for prevention of first heart attacks until the professional labeling claim is approved by FDA ("The Pink Sheet" March 7, p. 3), the first heart attack ads brought FDA and FTC attention to the second heart attacks ads, which have been running for almost three years. FDA established a working group to review the second heart attack ads shortly after the voluntary halt on ads for first heart attacks ("The Pink Sheet" April 11, p. 5). According to Peeler, FTC is "working very closely with FDA" on the evaluation of the current ads. FDA Associate Chief Counsel for Drugs David Adams indicated that initial efforts to regulate aspirin ads are likely to focus on the content of the promotions and not an all-out ban of the ads. Noting that "the only thing [FDA] could really do [about the aspirin ads] is prevent them all together," Adams said: "Before you hear anything from FDA on this issue of this sort of advertising, you may, in fact, hear something from FTC, because they actually have the authority to regulate the substance of this advertising. And while it's out there, if it's going to be out there, it's their prerogative to make sure that it's truthful and nonmisleading."

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