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.
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Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway
The year-end package of US FDA reforms reflects the impact of one now-retired US Senator: North Carolina’s Richard Burr’s objections helped take out a number of ‘anti-innovation’ provisions – while still securing inclusion of a ‘Platform Technologies’ pathway that might otherwise not have been enacted.
Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
Supply Chain Conversations Should Continue, But Industry Wants More Government Transparency
Healthcare Distribution Alliance CEO Chip Davis says drug wholesalers and suppliers need the government’s information on product demand, just as the government needs industry inventory data, to anticipate and avert shortages.