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West J Med. 2001 July; 175(1): 12–13.
PMCID: PMC1071452
News and Features

FDA warning to manufacturers of AIDS drugs

The US Food and Drug Administration (FDA) has issued a warning letter to manufacturers of AIDS drugs cautioning them to tone down the optimistic tenor of their anti-retroviral drug advertisements.

Thomas Abrams, director of the FDA's division of drug marketing, advertising, and communications, said that current antiretroviral advertisements directed at consumers are misleading because they fail to depict the limitations of AIDS drugs and also feature healthy-looking people who are not representative of typical patients with AIDS. The advertisements, therefore, violate the Federal Food and Drug Act.

The FDA's letter stated that many of the advertisements “do not adequately convey that these drugs neither cure HIV [human immunodeficiency virus] infection nor reduce its transmission.”

The pharmaceutical companies have 90 days to comply with the FDA's directive to modify their promotional advertisements.

The FDA's move was prompted by protests from AIDS activists in San Francisco who were angry that billboard and magazine advertisements portrayed sexy and athletic models in the prime of health who were climbing mountains, sailing boats, and riding bikes. These are pursuits that are difficult for people with HIV infection, who have to take drugs several times a day that have debilitating side effects.

Many of the billboard advertisements are displayed in predominantly homosexual communities. The grassroots demonstrations in San Francisco resulted in a public hearing calling for such advertisements to be banned in that city and in a petition to the FDA for a review of the advertisements.

Tom Ammiano, president of the San Francisco Board of Supervisors and himself an AIDS activist, led the hearing (see Media Watch, wjm June 2001). Among the concerns of the activists are that the glamorous advertisements give a false sense of security to people with HIV infection and may convince some to abandon safe sexual practices. They may think that, by popping a pill, AIDS can be avoided or completely managed.

Preliminary evidence supports the contention that the drug companies' advertisements may alter behavior by their overly optimistic message. A public health survey by Jeffrey Klausner, an epidemiologist in the San Francisco city health department, found that 61% of 422 men attending the city's sexually transmitted disease clinics thought that such advertisements indirectly encourage unsafe sex. Men who saw the advertisements were more likely to engage in unprotected sexual activities than those who did not. Results of the ongoing survey are accessible at

Moreover, Klausner believes that the advertisements may have contributed to the dramatic rise in HIV infections in San Francisco over the past 4 years. Although the number of AIDS-related deaths has declined, the number of new cases is rising, and drug resistance is emerging. The FDA's letter did not target any particular advertisement or drug company but was sent to all manufacturers of AIDS drugs.

The largest manufacturers of AIDS drugs are Abbott Laboratories, Agouron Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, DuPont Pharmaceuticals, GlaxoSmithKline, Hoffmann-LaRoche, and Merck. The drug companies were asked to reply by May 18, 2001, with plans to change promotional materials and with a stated date of when that would be accomplished.

The FDA's decision may lead to closer scrutiny of “direct-to-consumer” drug advertising.

Figure 1
The FDA has told drug manufacturers to tone down their overoptimistic messages

Articles from The Western Journal of Medicine are provided here courtesy of BMJ Publishing Group