Bipartisan No More: Top Dems Denounce Draft Biomedical Reform Legislation
Reps. Diana DeGette and Frank Pallone expressed disappointment with House Energy and Commerce 21st Century Cures bill; meanwhile Senate Republicans kick off their own reform process.
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Simplified and speedier drug approval process is focus for Reps. Upton and DeGette’s upcoming legislation – but getting there may mean more congressional micromanaging over FDA’s drug approval standards.
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.
Califf Clears First Senate Hurdle, But FDA Decision On Abortion Pill May Complicate Final Confirmation
Republican opposition to Califf over agency’s recent move to relax its Mifeprex restrictions is ominous since, in order be confirmed as commissioner, he’ll need enough GOP votes to make up for Democratic opposition over his opioid track record and connections to pharma industry.