Congress Dives Into Biomedical Innovation: Will It Drown In A Deep Sea Of Competing Needs?
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.
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All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
Senate eyes a biomedical reform process that is simultaneously narrower and slower than the House’s 21st Century Cures Initiative; FDA’s Hamburg asks for ability to shape sponsor’s trial designs earlier and more regulatory science funding.
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.