GAO Report On Medical Device Reviews, Criticism From Scientists Indicate Need For FDA Reform, Editorial States

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 28 Jan 2009 - 5:00 PDT

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A report recently released by the Government Accountability Office that found FDA for years "has failed ... to subject some of the riskiest devices to a rigorous review mandated by Congress," as well as concerns recently raised by FDA scientists, indicates the need for reforms at the agency, a New York Times editorial states. According to the editorial, the report found that FDA continues to use a review and approval process established in 1976 for high-risk, Class III medical devices and that the process does not ensure the safety and effectiveness of the products. A group of FDA scientists also recently "complained to the Obama transition team -- and before that to Congress and to the agency's commissioner -- that during the Bush years, managers in charge of medical device reviews had corrupted and distorted the process in ways that put the public at risk," the editorial states.

In response, the "Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over" and "make clear that the Bush administration's practice of distorting science and weakening regulation to favor industry also is over," according to the editorial. The editorial concludes, "Given its sorry performance in so many areas important to public health and safety, the agency is ready for a major overhaul" (New York Times, 1/27).

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