FDA Says AIDS Drug Ads Misleading, Must Be Changed in 90 Days
The FDA's Division of Drug Marketing, Advertising and Communications on Friday warned manufacturers of AIDS drugs that some direct-to-consumer advertisements may be in violation of the federal Food and Drug Act because they "do not adequately convey that these drugs neither cure HIV infection nor reduce its transmission," the AP/Sacramento Bee reports. Rather, the ads seem to "imply that with modern treatment people [do] not need to worry about AIDS," the paper says (Schmid, AP/Sacramento Bee, 4/29). The ads show seemingly "healthy looking young men engaged in an active lifestyle," using slogans such as "Mission Accomplished!" and "Going the distance" to promote antiretroviral drugs, including protease inhibitors (Kaiser Daily HIV/AIDS Report, 3/15). The warning letter from division Director Thomas Abrams, which did not "single out" any one drug company, said the ads also "minimize side effects of the drugs" -- which can include lipodystrophy and "facial wasting" -- and fail to mention that not every patient responds to treatment. As "promoting drugs without displaying their limitations and using images not representative of HIV patients" violates the Food and Drug Act, the FDA gave the companies 90 days to change the ads in question and asked drug makers to respond by May 18 with a list of the marketing materials to be changed and a timetable for doing so. San Francisco had considered banning the ads, which appeared on billboards, in magazines and in "other venues," if they were not "toned down," in light of a recent city health department survey that found 61% of 422 gay and straight men polled said the drug ads "affected decisions on whether to have unsafe sex." Jeff Getty, an advocate with Survive AIDS, said drug advertising has been a "problem" for years, but "it took AIDS to finally make the FDA act." AIDS deaths have "declined sharply" over the last few years due to improved drug therapies, but the AP/Sacramento Bee reports that infection rates among gay men are again on the rise in many metropolitan areas (AP/Sacramento Bee, 4/29).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.