FDA approved device despite problems during review
As a medical malpractice lawyer, I am concerned by the following story. The FDA, as the chief regulatory agency for new medical devices, has a duty to make sure the devices are as safe as possible, and it is crucial, therefore, that the review process is untainted.
Matthew Perrone reports, “The Food and Drug Administration's top lawyer says the agency failed to follow its own rules when it approved a knee repair product last year against the recommendation of its own scientists” (9/24, AP for FindLaw).
An internal examination by the FDA’s Chief Counsel raised concern that “agency leadership caved to pressure from the company,” in approving the ReGen Biologics’ Menaflex device.
FDA scientists rejected the product in question in both 2006 and 2007. FDA’s device division chief, who retired last month, overruled those decisions in 2008 leading to the approval of the ReGen’s device.
The probe, which was requested by Obama administration officials detailed several problems where there was concern about “a clear deviation from the principles of integrity.”
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