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FDA scientists report corruption at management level

January 9, 2009 by  

The FDA is accused of corruptionAmericans are being placed at risk by the misconduct of managers within the Food and Drug Administration, according to a letter penned by a group of scientists that was sent to the Obama transition team.

The letter, written on a letterhead bearing the name of the Center for Devices and Radiological Health, claims that the scientific review process for medical devices has been "corrupted and distorted," the Associated Press reports.

"Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws … and to accept clinical and technical data that is not scientifically valid," the letter reads.

They used the example of computer-aided mammography as an example. FDA scientists recommended against approving the devices five times, because research revealed they produced false alarms that led to unnecessary biopsies.

However, the FDA managers ignored the objections and ordered the technology to be approved, the letter states. This behavior signifies "the most outrageous conduct," the scientists say.

In recent years, the FDA drug and device approval process has come under attack from a number of corners.
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