2002 FDA Employee Survey Finds Drug Concerns

One-fifth of Food and Drug Administration (FDA) scientists surveyed two years ago as part of an official review said that they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. The survey of 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and one third were not confident of the agency’s ability to assess the safety of a drug.

In the survey, 18 percent of respondents said they had been "pressured to approve or recommend approval for a new drug application despite reservations about the safety, efficacy, or quality of the drug." Similarly, 21 percent of surveyed respondents said the work environment at the FDA’s Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely.

The results of the survey, conducted by the Health and Human Services Department’s inspector general, appear to support Dr. David Graham’s Senate testimony last month on the safety of current drugs on the market. Dr. Graham stated recently that "I think this provides evidence that among reviewing scientists at the FDA, their experiences mirror the testimony I gave before Congress." "It also shows the unfortunate experience of many mirrors of what happened to me when I tried to bring safety issues to my mangers and the American public."

The complete survey was made public in December by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two groups that received the documents through the Freedom of Information Act.

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