Contributed by Carla Sharetto| 17 December, 2004 02:15 GMT
An internal survey of Food and Drug Administration (FDA) scientists conducted in 2002 shows that many of the agency's staff lacked confidence in its drug approval practices and were concerned about the safety of prescription drugs on the market. The survey results correspond closely with the safety concerns expressed by the agency's own Associate Director for Science and Medicine, Dr. David Graham, in testimony before the U.S. Senate last month.The Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) obtained the survey through the Freedom of Information Act and jointly released the document on Thursday.
'High Confidence' Conclusion Questionable
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 include the following:
- 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."
Inadequate Mechanisms for Addressing Dissent
"The survey raises significant issues about drug safety and ongoing monitoring of adverse health impacts of drugs in the marketplace," states 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," says 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 his concerns, but that those warnings are falling on deaf ears." |
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