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MDMA Statement on FDA User Fees and Appropriations

Tuesday, January 14, 2014  
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MDMA Statement on FDA User Fees and Appropriations
Omnibus package restores collected user fees and increases FDA funding

WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the restoration of user fees and increased funding for FDA included in the FY 2014 Omnibus Appropriations bill. The legislation provides $85 million to restore the loss of funds that had been collected in FY 2013, as well as an increase of $91 million in discretionary funding, above the FY 2013 enacted level.

"MDMA applauds the bipartisan efforts of the House and Senate to restore user fees to FDA that were denied as a result of sequestration.  The milestones that were negotiated as a part of MDUFA reauthorization are an important component to securing America’s leadership in medical technology innovation, and this legislation reinforces Congress’ support of this goal.

"In addition, it is crucial that FDA has adequate appropriations to help maintain the integrity of the MDUFA program and other regulatory activities.  The increase in funding for the FDA sends a strong message that this is a Congressional priority as well.

"MDMA continues to work with Members of Congress and policy makers to ensure that a safe, transparent and effective regulatory pathway exists to promote patient care and innovation.”