LA JOLLA, Calif. (PRWEB) November 18, 2013
Today, a coalition of more than 30 state and regional life sciences associations, including the California Healthcare Institute (CHI), sent House and Senate Budget Conferees a letter urging swift action to exempt U.S. Food and Drug Administration (FDA) user fees from sequestration.
Last year, passage of the FDA Safety and Innovation Act (FDASIA) renewed FDA’s authority to collect user fees and provided much needed improvements to regulatory review processes. In fact, industry agreed to pay increased user fees in order to facilitate the needed system and process improvements under the renewed FDA user fee law. Since its inception for drugs in 1992 and for devices in 2002, the user fee program at the FDA has increasingly relied on industry-paid user fees to supplement congressional appropriations for its product review activities. Under FDASIA, user fees now fund approximately 60-65 percent of the cost of FDA human drug and biologics review activities, and approximately one-third of the cost of FDA device and diagnostics review activities.
According to the Office on Management and Budget and U.S. Department of Treasury, sequestration has reduced FDA’s budget authority for user fees by $85 million in FY2013.
“Ending the sequestration of user fees is a top priority of CHI,” said Todd Gillenwater, senior vice president of public policy for CHI, the public policy association representing California’s statewide life sciences sector. “This letter, signed by more than two dozen state and regional life science associations, demonstrates the significant nationwide concern about the impact of user fee sequestration on FDA’s ability to carry out its critically important mission to bring safe and effective new drugs, biologics, devices and diagnostics to patients.”
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 policies that foster medical innovation and promote scientific discovery. CHI’s website is http://www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.