Bipartisan Bill Introduced Exempting FDA User Fees from Sequestration
Wednesday, July 24, 2013
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.
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.