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Survey Finds FDA Lacks Independence from Outside Pressures

A survey conducted by the Union of Concerned Scientists found that scientists at the Food and Drug Administration (FDA) feel that their work is subject to outside pressures, both political and commercial, and that these pressures influence agency conclusions for the public. The anonymous survey was sent to close to 6,000 FDA scientists and 997 responded, 62 percent of whom are senior scientists.

The survey found that 18 percent of the scientists had been asked “for non-scientific reasons, to inappropriately exclude or alter technical information” for FDA documents. Sixty-one percent had knowledge of instances where political appointees had “inappropriately injected themselves into FDA determinations or actions.” Seventeen percent, or 169 scientists, responded that they had been asked to “provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials.”

The results of the survey come as the Senate continues its committee hearings for the permanent appointment of FDA acting commissioner, Dr. Andrew von Eschenbach. The concern that the petition for over-the-counter status of emergency contraception, or Plan B, has been affected by political pressure was reflected in yesterday’s hearings, as Senators asked von Eschenbach repeatedly about his reasoning behind Monday’s announcement that he would consider granting over-the-counter status for emergency contraception only for women 18 years old and above. He could cite no scientific data for the classification. Another common line of questioning was how he intended to create a greater independence of the agency from outside pressure, according to the Washington Post.

“Science must be the driving force for decisions made at the FDA,” said Dr. Francesca Grifo, Senior Scientist at the Union of Concerned Scientists, about the survey. “These disturbing survey results make it clear that inappropriate interference is putting people in harm’s way.”

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Sources:

Kaiser Daily Health Policy Report 7/21/06; Union of Concerned Scientists press release 7/20/06; Union of Concerned ScientistsÕ FDA Scientific Survey 7/06; Washington Post 8/2/06

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