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Contact:
Mark Brager
202-434-7244
mbrager@advamed.org
August 1, 2013

AdvaMed Applauds Senate 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 the introduction in the U.S. Senate of bipartisan legislation (S.1413) exempting FDA user fees from cuts under sequestration:

“Since the sequester took effect earlier this year, medical device and diagnostics companies have been paying the full amount of user fees to FDA as negotiated under last year’s new Medical Device User Fee Agreement, as enacted in the FDA Safety and Innovation Act (FDASIA); however, sequestration prevents the agency from accessing the full amount of those funds. In FY 2013 alone $2.9 million in medical device user fees will not be available to the agency, and going forward, additional user fees are at risk because of sequestration.

“AdvaMed would like to thank Sens. Mark Pryor (D-AR), Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN) and Jerry Moran (R-KS) for their support of legislation which would fix this unfortunate circumstance and allow FDA to have full access to the user fees paid by medical technology companies. Similar legislation was recently introduced in the House by Reps. Leonard Lance (R-NJ) and Anna Eshoo (D-CA).

“User fees paid by industry to FDA should not be treated the same way as taxpayer dollars. The fees paid by medical technology companies under FDASIA 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, S.1413 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.

“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.”

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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. For more information, visit www.advamed.org.