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Bipartisan Bill Introduced Exempting FDA User Fees from Sequestration

Wednesday, July 24, 2013  
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A bipartisan group of members of the House of Representatives recently introduced a bill that would exempt FDA user fees from sequestration cuts.  The bill, H.R. 2725 or the "FDA Safety over Sequestration Act of 2013” was introduced on July 18th by Reps. Lance (R-NJ), Eshoo (D-CA), Matsui (D-CA), and Rogers (R-MI) and will prevent FDA user fees from being subject to sequestration cuts.


Since the sequester took effect March 1, 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, these fees have not been available to the agency.


"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," said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed).


"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."


Virginia Bio's national affiliates BIO, PhRMA, MDMA and AdvaMED all support this legislation.

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