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AdvaMed Praises 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 today following the introduction in the U.S. House of Representatives of bipartisan legislation that would exempt FDA user fees from cuts under sequestration:
“AdvaMed would like to thank Reps. Leonard Lance (R-NJ), Anna Eshoo (D-CA), Doris Matsui (D-CA), Mike Rogers (R-MI) and the other co-sponsors of this legislation, which will allow FDA to have full access to the user fees paid by medical technology companies and other FDA-regulated industries.
“Since the sequester took effect March 1, medical device and diagnostics companies have been paying the full amount of user fees to FDA as negotiated under last year’s FDA Safety and Innovation Act (FDASIA); however, because of sequestration, in FY 2013 alone $2.9 million in medical device user fees will not be available to the agency. Going forward into next year and beyond, additional medical device user fees are at risk because of sequestration.
“User fees paid by industry to FDA are fundamentally different from appropriated funding. The fees negotiated 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. User fees are not taxpayer dollars.
“By exempting FDA user fees from the sequester, this legislation will restore the agreement negotiated by industry, the agency, and the Congress and ensure that FDA will be able to use all the funds paid by industry for the improvement of the review process. That is in the best interest of 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.”
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.