FDA leaders have expressed concerns that the sequestration of user fees puts at risk key commitments negotiated under last year’s renewal of the user fee programs through FDASIA, and may result in delays in the availability of novel and important new drugs and devices for patients. The Center for Drug Evaluation and Research Director Janet Woodcock, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D. echoed these concerns at Friday’s House Energy & Commerce Subcommittee on Health hearing on the agency’s progress in implementing FDASIA.
In July, Rep. Anna G. Eshoo (D-Palo Alto) together with a bipartisan collection of California members, including Reps. Tony Cárdenas (D-San Fernando Valley), Sam Farr (D-San Francisco), Doris Matsui (D-Sacramento), Scott Peters (D-San Diego), David G. Valadao (R-Hanford) and Henry A. Waxman (D-Santa Monica), introduced legislation that would eliminate future sequestration of industry-paid user fees. In order to make the legislation budget-neutral, the bill – H.R. 2725, the FDA Safety Over Sequestration, or FDA SOS Act – does not address the user fees already sequestered in FY2013 or FY2014. H.R. 2725 currently has 68 cosponsors, including 24 members of the California congressional delegation.
“User fees are private monies – not federal taxpayer dollars,” said Gillenwater. “We hope the budget conferees take into consideration this multi-state life science association letter, along with the growing number of bipartisan cosponsors of H.R. 2725, and adopt this no-cost, common sense fix as part of any upcoming budget agreement.”
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public
Copyright©2012 Vocus, Inc.
All rights reserved