Survey questions FDA drug standards Advocacy group sought opinions of employees

December 03, 1998|By NEW YORK TIMES NEWS SERVICE

Releasing its own survey of doctors who work for the Food and Drug Administration, an advocacy group accused the agency yesterday 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 drew 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, directed by Dr. Sidney Wolfe and founded by consumer advocate Ralph Nader in 1971.

The people surveyed were medical officers, agency employees assigned to oversee individual drugs being evaluated for approval. The survey was anonymous and completed by only 53 of the 172 people to whom it was mailed -- making it impossible to tell whether the survey found genuine problems or merely provided malcontents an outlet for gripes.

Among its findings:

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

* 17 said the food and drug agency's safety and efficacy standards were lower than in the past.

* 19 said they felt more pressure to approve drugs from within the agency and from Congress and the pharmaceutical industry.

Pub Date: 12/03/98

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