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MDMA Applauds Bipartisan Legislation to Exempt FDA User Fees from Sequestration

Thursday, July 18, 2013  
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In a letter to lead cosponsors today, MDMA issued its strong support for the "FDA Safety Over Sequestration Act,” or "FDA SOS Act,” introduced by Representatives Leonard Lance (NJ), Anna Eshoo (CA), Mike Rogers (MI) and Doris Matsui (CA). The bipartisan bill would exempt industry funded Food and Drug Administration (FDA) user fees from sequestration.

"These private sector dollars are paid by companies as a result of negotiated agreements among FDA, industry and Congress,” said Thomas Novelli, MDMA’s Vice President of Government Relations. "It is not appropriate for industry funded monies to be included in sequester related appropriation reductions.”

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.

The most recent authorization of the Medical Device User Fee Program, MDUFA III, resulted in increased user fee payments in return for greater accountability, predictability and transparency from FDA as well as the hiring of additional staff. The goal of these negotiations was to decrease review times without sacrificing safety in order to provide patients and physicians with timely access to life-saving products and therapies. FDA’s inability to access user fees that have already been collected would significantly harm their ability to meet these negotiated obligations.

In the end, we must protect FDA’s important goals of achieving safe, efficient and timely review of life-saving medical products and devices. On behalf of the hundreds of innovative and entrepreneurial medical technology companies, many of which independently contribute user fees in order to ensure that patients get timely access to safe and effective  products, MDMA looks forward to working with these representatives and other cosponsors to ensure that the FDA SOS Act becomes law.