Wednesday, January 28, 2009

FDA Whistleblowers Fear Retribution

The New York Times reports that "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."

In the letter, the FDA scientists write, "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! 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 nine scientists have written a number of letters this year, to Congressional leaders and members of the Obama transition team charging "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." But under the law, "it can be a crime for agency employees to reveal documents or information considered confidential by companies seeking agency approval for medical products."

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