As Congress considers reauthorizing a law that sets the fees for medical device makers, device companies are finding a ready ally in venture capitalists. Together, they are eager to remove what they see as regulatory roadblocks in the approval process. Congressional members, including Minnesota Congressman Erik Paulsen, have responded by sponsoring legislation which would greatly compress the process for bringing new medical devices to the U.S. market.
This legislative push comes amidst patient advocates and some doctors calling for increased FDA oversight. They point, for example, to the recent recall of all-metal hip replacement devices marketed by DePuy. The DePuy recall came too late for the thousands of patients worldwide who were seriously injured by the device. The devices had an alarming rate of failures and many patients had to undergo costly and painful surgery to remove the devices shortly after having them implanted. Between 2008 and 2010 when the device was recalled, the FDA received over 300 complaints from the patients in the United States regarding the hip device.
Still, F.D.A. officials have tried to address investors’ concerns about the approval process. The head of the agency’s device division has noted that the dialogue between investors, device companies and the federal safety agency has become increasingly politicized. This further complicates any real discussion on how to make the process industry-friendly without compromising patient safety.
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