- Created on Wednesday, 15 January 2014 20:23
- Written by IVN
Washington, DC - Last week, Congressman Juan Vargas (CA-51), along with 33 other Members of Congress, coauthored a letter to the House and Senate Appropriations Committees, urging the release of sequestered Food and Drug Administration (FDA) user fees in the FY 2014 Omnibus Appropriations bill. The bill, which was unveiled on Monday, includes language releasing the $85 million in sequestered FY2013 FDA user fees and increasing funding for the FDA.
“The sequestration of user fees has impacted the ability of the FDA to fulfill its critical public health mission, which includes bringing new medicines and technologies to patients in a timely manner,” said Rep. Juan Vargas. “I am extremely pleased to see an increase in funding for the FDA, as well as the release of the sequestered user fees in the Omnibus Appropriations bill. Maintaining robust funding for the FDA is essential to promoting innovation and entrepreneurship, and creating more jobs in the thriving San Diego biotechnology community.”
The FDA uniquely relies on two sources of revenue: congressionally-directed appropriations and user fees, with user fees comprising more than 60% of the human drug review budget alone. These user fees are intended for specific purposes, such as the review and approval of new medical therapies or devices. The Office of Management and Budget (OMB) included FDA user fees in sequestered resources even though they are not government dollars and cannot be used for deficit reduction. As a result, in 2013, $85 million in user fees remained in budgetary limbo unavailable to the FDA for human drug or medical device review.
“The agreement unveiled on Monday releases the $85 million of industry-paid FDA user fees sequestered in 2013 and increases FDA funding in 2014. These user fees directly go toward advancing and approving much-needed new medicines and therapies for patients, many of which are being developed here in San Diego,” said Todd Gillenwater, senior vice president for public policy at California Healthcare Institute (CHI) – the statewide public policy organization representing California’s leading biomedical innovators, including more than 275 medical device, diagnostic, biotechnology and pharmaceutical companies, research universities and private, nonprofit institutes and venture capital firms. “CHI commends Congressman Vargas for his strong support in correcting the FDA user fee sequester in the omnibus and as a supporter of H.R. 2725, the FDA Safety Over Sequestration or FDA SOS Act, which would permanently protect user fees in the future.”