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Bill to Exempt FDA User Fees from Sequestration Introduced in the Senate

Wednesday, July 31, 2013  
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Senator Mark Pryor (AR) introduced a bipartisan bill today, the FDA Safety and User Fee Protection Act, which would exempt user fees paid by medical device and pharmaceutical companies to the Food and Drug Administration (FDA) from sequestration. Original Cosponsors include Senators Roy Blunt (MO), Dan Coats (IN), Al Franken (MN) and Jerry Moran (KS).

 The bill serves as a companion bill to legislation introduced in the House of Representatives two weeks ago. It is estimated that the Center for Devices and Radiological Health (CDRH) would lose approximately $2.9 million in user fees for fiscal year 2013 and approximately $16 million in total fees if the sequester is not exempted.

As a result of the most recent MDUFA authorization, increased user fees have begun to be paid to FDA by industry in return for the Agency meeting negotiated goals and benchmarks. MDMA is working with Congress and monitoring this issue very closely to ensure that FDA has access to all industry funded dollars in order to meet MDUFA III goals of greater accountability, predictability and transparency.