WASHINGTON -- The federal government has repeatedly reprimanded drug companies in recent months after finding that they had made false or misleading claims in television commercials and magazine advertisements for a wide range of prescription drugs.
Such advertising has exploded as drug companies market their products directly to consumers, and the government is now scrambling to keep up with Madison Avenue.
In the last year alone, the Food and Drug Administration has admonished companies about commercials advertising drugs for allergies, asthma, high cholesterol, high blood pressure, hair loss and sexually transmitted diseases. It also has found problems in advertisements for birth control pills, anticancer drugs and medicines to help people lose weight and stop smoking. In most cases, the regulatory agency said, the advertisements violated the federal Food, Drug and Cosmetic Act because they overstated the benefits of a particular drug, minimized the risks or falsely suggested that one drug was superior to another. The agency also found that many companies had been promoting their drugs for uses not approved by the government. The FDA typically demands that the use of such advertisements "cease immediately." Drug companies generally agree to stop making the claims to which the agency objects. In rare cases, the government has required corrective advertising, to offset what officials saw as inaccurate information in prior advertisements. In a typical comment, Daniel J. Watts, a spokesman for Pharmacia & Upjohn, cited for improper advertising in the last year, of contraceptive drugs and those to treat male impotence, said, "We were not in total agreement with everything the FDA said, but we complied with what the agency wanted us to do." He defended advertising aimed at consumers, saying, "That's how people find out about new therapies." Though companies dislike being cited for violations, they applaud the FDA when it accuses their competitors of similar infractions. Federal rules say drug companies must submit their advertisements to the FDA "at the time of initial dissemination" or publication. The agency generally does not have the power to review commercials before they run. But an exhaustive review of more than 100 agency letters asserting violations of federal drug-advertising standards shows that, in practice, the agency often operates as an editor, criticizing the text and the design of advertisements, including details like the size of type. Under the rules, information about the risks and the benefits of a drug must be presented in "reasonably comparable" ways, so there is a fair balance. But advertisements, especially television commercials, often fail this test, the agency says. Premarin, for example, made by Wyeth-Ayerst Laboratories to treat symptoms of menopause and osteoporosis, is one of the most frequently prescribed drugs in the United States. The FDA said that in a television commercial for Premarin, "multiple distracting visual images and activity occur during the audio presentation of the risk information," but the drug's benefits are described clearly and cogently, against a visual background without any distractions. …