"All-Hands Meeting" Called At FDA To Discuss Lax Medical Device Oversight

Michael Phelan

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Nine scientists signed letters to President Obama charging that Food and Drug Administration officials had acted illegally and that patients were routinely put at risk by unsafe medical devices approved by the FDA for sale despite significant and often unanimous objections from scientific reviewers at FDA. These scientists sent many e-mails to the FDA's prinicpal deputy commissioner, seeking his intervention, but the deputy commissioner, Joshua Sharfstein, M.D., replied that he was "already burning the candle at both ends to keep up with his job." The nine dissident scientists sent an extensive memorandum to Dr. Sharfstein charging that the "regulatory review process for medical devices has been severely distorted" and that those who raised concerns about unsafe devices had been retaliated against by agency managers.

Amond the devices alleged to have been approved inappropriately are imaging equipment for detecting breast cancer and an orthopedic knee device. The FDA also allowed hospitals to wash and reuse sterile surgical devices intended for just one use. Sounds like a great idea in this era of MRSA and other deadly bacteria and viruses. Undue influence from the device manufacturers is no-doubt a cause for some of these inappropriate approvals. The other reason is captured in Dr. Sharfstein's above-cited quote- the agency is too understaffed to do its job; hence it relies too much on safety and efficacy information provided by the drug and device manufacturers. The fox has been allowed to guard the chicken house. This is why preemption arguments are such a joke. When Newt Gingrich introduce the Contract With America, it contained a provision to turn the FDA over completely to the drug and device industry and let them regulate themselves. Thank God that did not happen.

There are signs that the FDA may take steps to kick the fox out of the chicken house. On April 10, Donna-Bea Tillman, director of the FDA's office of device evaluation, announced an "all-hands meeting" of all scientists within the office to discuss the strategic direction of the device center. This would be the first meeting of its kind in years. Under the previous administration, meeting time was awarded to industry lobbyists rather than the scientists charged with evaluating safety.