Industry trade association AdvaMed said Wednesday it applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
The bill was introduced by Rep. Leonard Lance (R-N.J.) and Rep. Anna Eshoo (R-Calif.) Under the Medical Device User Fee Amendments of 2012, the FDA is empowered to collect fees from medical device makers to help expedite the product approval process.
“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,” said Stephen Ubl, AdvaMed’s president and CEO, in a statement issued Wednesday.
“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,” Ubl continued.
“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,” Ubl added.
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