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AdvaMed Applauds House Legislation Exempting FDA User Fees from Sequestration
WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement after introduction in the U.S. House of Representatives of the bipartisan FDA SOS Act to exempt FDA user fees from cuts under sequestration:
“AdvaMed commends Reps Leonard Lance (R-NJ) and Anna Eshoo (D-CA) for their leadership in introducing legislation which will ensure FDA has full access to the user fees paid by medical technology companies.
“We have long maintained that user fees paid by industry to FDA should not be treated under sequestration the same way as taxpayer dollars. The fees paid by medical technology companies under the 2012 Medical Device User Fee Agreement represent an agreement between industry, FDA and Congress. Under that agreement, industry agrees to supplement FDA’s appropriated budget with user fees, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process.
“By exempting FDA user fees from the sequester, the FDA SOS Act restores the agreement negotiated by all three parties and ensures FDA will be able to use all the funds paid by industry to improve its review process. That is a win-win-win for FDA, the industry and the millions of American patients who will benefit from more timely access to innovative medical technologies.
“The Omnibus Appropriations legislation passed in January 2014 retroactively restored $2.85 million of sequestered user fees to FDA from FY 13, and the Murray-Ryan budget deal eliminated threated cuts for FY14 or FY15. However, going forward into FY16 and beyond, additional medical device user fees are at risk since sequestration cuts could come into effect once more. This situation requires a permanent fix.
“We look forward to working with Congress and other stakeholders to address this important issue and to prevent any further restrictions on FDA’s access to user fees.”
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.