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A previously unpublished internal survey of Food and Drug Administration (FDA) scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs,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.”