US FDA warns pharma over AIDS DTC ads

The US Food and Drug Administration has told makers of HIV/AIDS drugs toamend direct-to-consumer advertising for the treatments. The FDA Division of Drug Marketing, Advertising and Communications' review of the ads found that many "do not adequately convey that these drugs neither cure HIV infection nor reduce its transmission." Some minimize the drugs' side effects, it says, and reminds firms that not all patients respond to drug treatment.

Moreover, the ads' promotion of drugs without displaying their limitations, and their use of unrepresentative images of HIV patients, violates the federal Food, Drug & Cosmetic Act, and must be changed within 90 days, it says. No firms have been singled out, although the Department has sent its advisory notice to all makers of HIV/AIDS drugs, asking them to respond by May 18 with details of how and when the ads will be changed.

The FDA said it would examine the ads after the San Francisco Department of Public Health warned that it was considering banning their display on city property following criticisms that the "sexy" ads were trivializing the disease and encouraging unsafe sexual practices (Marketletters March 26 and April 23).