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Scientists Say FDA “Fundamentally Broken”

January 9, 2009

Scientists at the US Food and Drug Administration have sent a letter to President-elect Barack Obama’s transition team urging him to revamp the agency, claiming that it “has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.”

Nine scientists who claim the FDA is a “fundamentally broken” agency authored the letter, sent Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

“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 center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

The letter was obtained by the Associated Press without the names of the scientists, which were provided to Obama’s transition team.

Tom Daschle, Obama’s pick for head of Department of Health and Human Services, is likely to be in charge of revamping the agency.

“We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action,” said FDA spokeswoman Judy Leon in response to the letter’s claims.

The authors cited an example in which the FDA approved some mammography computer-aided detection devices without clinical evidence showing they were effective in detecting breast cancer.

The group says they have taken their concerns to the head of the FDA, Commissioner Andrew von Eschenbach, and his assistant commissioner for accountability and integrity, attorney Bill McConagha.

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