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  Dissidents at F.D.A. Complain of Inquiry
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ContributorArmyDem 
Last EditedArmyDem  Jan 27, 2009 11:24pm
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MediaNewspaper - New York Times
News DateWednesday, January 28, 2009 05:00:00 AM UTC0:0
DescriptionBy GARDINER HARRIS
Published: January 27, 2009

Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.

“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!” states the letter, which was provided to The New York Times. “It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress.”

Heidi Rebello, an F.D.A. spokeswoman, said she could neither confirm nor deny the existence of a criminal investigation.

The letter is the latest escalation in a highly unusual internal battle that has been simmering for nearly a year within the agency’s device division. The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective.

The scientists complained in May to Dr. Andrew C. von Eschenbach, who was then the F.D.A. commissioner, and the agency began an internal review that continues. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one, which also continues.
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