Scientists at FDA's Medical Device Center Claim Agency is Mismanaged and Bends to Manufacturers' Demands

CNN is reporting that nine scientists at the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) have written a six-page letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk." Among the charges are that scientists have been threatened and told, on occasion, to ignore FDA regulations, that FDA managers have ignored serious safety and effectiveness concerns, and that FDA experts have been excluded from product meetings because manufacturers felt that they were "biased." An AP story provides additional details.

UPDATE: We have not located a copy of the letter to the President-elect, but it is believed to be a somewhat more detailed version of a letter CDRH scientists sent to Rep. John Dingell last October.

Comments

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is there any update on this

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I am beginning to really lose all faith and credibility in the FDA. It seems to me that instead of focusing their efforts on protecting the general public they are in-turn being influenced by corporate agenda and special interest. I take everything they say with a grain of salt.

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what a strange case, I lose faith in these institutions too