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
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