Status Quo Senate Still Means Big Changes For FDA Oversight
The mid-term elections left the US Senate under Democratic leadership – but there are still big changes coming that may make life tougher on FDA and the brand name industry.
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Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.
With a slim House majority, will Republicans wade into Medicare coverage policy for a promising Alzheimer’s drug and the new Medicare price negotiation program? Democratic Senate could offer ‘counter oversight’ hearings.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.