NADER GROUP ACCUSES FDA OF APPROVING TOO QUICKLY

Health: The allegations are based on anonymous responses from doctors within
the agency.

Releasing its own survey of doctors who work for the Food and Drug
Administration, an advocacy group accused the agency Wednesday of lowering
its standards for safety and efficacy, working too hastily and approving
drugs that should never have been allowed on the market.

The report has drawn a scathing rebuttal from the drug industry, an oblique
defense from the agency and criticism from representatives of chronically
ill people who advocate swifter drug approval.

But some scientists said the report raised significant concerns.

The survey, announced at a news conference, was conducted by the Public
Citizen's Health Research Group of Washington, which was founded by consumer
advocate Ralph Nader in 1971. The organization has criticized the
pharmaceutical industry and the drug-approval process, which Congress
accelerated in 1992 and 1997.

The people surveyed were medical officers, agency employees assigned to
oversee individual drugs being evaluated for approval. The survey was
anonymous and completed by 53 of the 172 people solicited.

Among its findings were these:

Nineteen medical officers identified 27 new drugs that were approved even
though the officers thought they should not be.

Seventeen said the food-and-drug agency's safety and efficacy standards have
been lowered.

A majority of the medical officers did not answer the survey, and a majority
of those who did answer did not complain, making it impossible to tell
whether the survey found genuine problems or merely provided malcontents an
outlet for gripes.

Checked-by: Don Beck