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
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
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
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
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. …