FDA SCOLDING DRUG FIRMS OVER MISLEADING ADS

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 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 has also found problems in
advertisements for birth-control pills, anti-cancer 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 drug, minimized the risks or falsely suggested that one
drug was superior to another. The agency also found that many
companies had promoted 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, an executive of Pharmacia &
Upjohn, cited in the last year for improper advertising 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.

Reviewing ads

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.

The government told Wyeth-Ayerst to withdraw this and other
advertisements because, it said, they made ``broad and ambiguous
health claims for Premarin,'' promising benefits that had ``yet to be
substantiated or even identified.''

Audrey A. Ashby, a Wyeth-Ayerst executive, said the company had
complied with the agency's request to stop running the advertisements.
In the future, she said, the company will submit any television
commercials that mention Premarin or other drugs by name, so they can
be reviewed by the government before they are broadcast.

Distracting from risks

Likewise, the government said, information about the risks of
Depo-Provera, an injectable contraceptive, was jumbled in the audio
and visual parts of a TV commercial.

The multiple messages ``virtually ensure that consumers will have
trouble fully comprehending any of the information,'' the FDA said in
a letter to Pharmacia & Upjohn, the manufacturer.

John F. Kamp, senior vice president of the American Association of
Advertising Agencies, said prescription drug companies spent $1.3
billion on print and broadcast advertising aimed at consumers last
year, up from $843 million in 1997 and $595 million in 1996.

He said drug companies did not want to get into fights with the FDA
over advertising because they feared the agency might retaliate by
delaying the approval of their applications for the marketing of other
drugs. Federal officials said such fears were baseless, but Kamp said
the perception was nevertheless widespread in the industry.