Friday, January 16, 2009

GAO report on FDA approval process

The Washington has an interesting report today on a report by the Government Accountability Office on the FDA approval process for high risk medical devices. Currently, there are two ways to get FDA approval for medical devices. Manufacturers of low-risk devices can get cleared by notifying the FDA before going to market. High-risk devices such as pacemakers and heart valves have to go through tighter scrutiny, and their manufacturers are supposed to provide evidence of safety and effectiveness. However, manufacturers can get approval for new versions of high-risk devices already on the market by convincing the FDA that these devices were "substantially equivalent" to their precursors. According to the article, in 1990 Congress ordered the FDA to end the practice, but it has continued. The FDA acknowledged the problem, but has not set a timetable for resolving it. The GAO report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints, external defibrillators, and electrodes for pacemakers. According to Public Citizen's health research group, "It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk." The article also quotes Rep. Frank Pallone, who heads the House Energy and Commerce Committee's health panel, who said "GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate." Apparently, there is some support to make the FDA review all medical devices through pre-market approval, rather than the less rigorous pre-market notification. Doing so, would increase the amount of time it takes to get new devices in the market, but it may reduce the risks that those devices will malfunction or cause other problems - as a number of (now recalled) devices approved under the less rigorous process have.

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