Cost Of FDA Reforms Is Big Challenge For ‘Cures’ Legislation
Drug industry warns that unfunded mandates in the 21st Century Cures discussion document could impact FDA’s ability to focus on drug reviews; Energy and Commerce legislators are working to get appropriators on board.
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House Energy and Commerce committee says it’s committed to a bill to accelerate U.S. biomedical innovation before the next FDA user fee cycle, but the wide scope of needs and stakeholders may make crafting legislation challenging – never mind getting it passed.
User fees, not appropriations, will make up the bulk of FDA’s human drug spending if President Obama’s FY 2014 budget comes to pass, a trend fueled by new user fee programs and cuts to taxpayer funding.