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Many FDA Scientists Had Drug Concerns, 2002 Survey Shows

Via Washington Post (December 16, 2004):

Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality.

The survey of almost 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 that more than a third were not particularly confident of the agency’s ability to assess the safety of a drug.

The results of the survey, conducted by the Department of Health and Human Services’ inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.

Graham’s testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA’s safety and management record. Top FDA officials later criticized Graham’s testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views.

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FDA Scientists Issued Early Warnings on Drug Approvals

Union of Concerned Scientists (December 16, 2004):

A previously unpublished internal survey of Food and Drug Administration (FDA) scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER). The FDA survey results, obtained under the Freedom of Information Act, closely track the safety concerns raised by the agency’s own associate science director of the Office of Drug Safety, Dr. David Graham, in testimony before the U.S. Senate last month.

The Health and Human Services Office of Inspector General (OIG) conducted the survey in late 2002 as part of a management review of how the agency was meeting stringent deadlines for approving new drugs. OIG polled 846 FDA scientists, with nearly half (47%) completing the survey. Survey findings included:

  • Two-thirds (66%) of respondents lacked confidence that the agency “adequately monitors the safety of prescription drugs once they are on the market”
  • Only 12% of scientists were completely confident that FDA “labeling decisions adequately address key safety concerns,” while 30% were not at all or only somewhat confident
  • More than one-third (36%) of scientists were not at all or only somewhat confident that “final decisions adequately assess the safety of a drug”
  • Nearly one in five scientists (18%) said that they “have been pressured to approve or recommend approval” for a drug “despite reservations about the safety, efficacy or quality of the drug”
  • Despite the disquieting survey results, when the OIG published its report in March 2003, a lead conclusion was that FDA scientific reviewers “have high confidence in decisions FDA makes.”

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