PRESS RELEASE

FDA SCIENTISTS ISSUED EARLY WARNINGS ON DRUG APPROVALS

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Washington, D.C. — A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according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 Director for Science and Medicine, Dr. David Graham, in testimony before the U.S. Senate last month.

The Health and Human Services Office of Inspector General 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”; and
  • 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.”

“The survey raises significant issues about drug safety and ongoing monitoring of adverse health impacts of drugs in the marketplace,” stated Kathleen Rest, executive director of UCS. “The scientists concerns warrant further investigation as Congress reviews drug approval practices at FDA.”

The fact that Dr. Graham’s supervisors have publicly disparaged his testimony highlights a weakness in FDA’s ability to dispassionately resolve scientific differences. In the survey of scientists, less than one in five (17%) felt the agency had “adequate procedures in place to address scientific disagreements” to a “great extent,” while 45% felt adequate procedures existed only to “some extent” and more than a third (38%) said procedures for resolving dissent existed only to a “small extent” or “not at all.”

“By all appearances, FDA would rather be sorry than safe,” stated PEER Program Director Rebecca Roose who obtained the survey under the Freedom of Information Act. “These results show that many of Dr. Graham’s colleagues share is concerns, but that those warnings are falling on deaf ears.”

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Read the summary of FDA survey findings

See the question-by-question survey results

See the HHS Office of Inspector General Report

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The Union of Concerned Scientists is a nonprofit partnership of scientists and citizens combining rigorous scientific analysis, innovative policy development and effective citizen advocacy to achieve practical environmental solutions.