FDA Scientists Ask Obama to Restructure Drug Agency
By ALICIA MUNDY and JARED A. FAVOLE
WASHINGTON -- A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.
The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal.
"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.
The letter will likely increase pressure on Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, to make sweeping changes at the agency.
The scientists' main concerns are with the agency's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."
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