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FDA Scientists Issued Early Warnings on Drug Approvals
Staff Survey Echoes Safety Concerns Raised by Dr. Graham in Senate Testimony
Washington, D.C.—A previously unpublished internal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 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 (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:
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Two-thirds (66%) of respondents lacked confidence that the agency
“adequately monitors the safety of prescription drugs once they are on
the market”
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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.”
“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 his concerns, but that those warnings are
falling on deaf ears.” |
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To set up interviews or for UCS info, contact:
SUZANNE SHAW
Director of Communications
617-547-5552
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