Reuters: FDA has shelved the commissioner’s national priority voucher program
- Reuters, citing six anonymous sources, reports the FDA has shelved the Commissioner’s National Priority Voucher program started under Marty Makary; applications can still be filed but reportedly won’t advance.
- 22 drugs have received a voucher and 12 are approved; none have been awarded since Makary left in May, and the political-appointee council that oversaw reviews has gone dormant.
- The FDA says work under the pilot is ongoing. Heidi Overton’s Senate vote as commissioner is set for Nov. 18.
💡 Points Based on public reports
For sponsors the issue is not the 22 existing vouchers but the lost option: a one-to-two-month review was a planning variable for launch timing and, indirectly, for deal valuations. RBC sees little effect on holders like Compass Pathways given other priority routes, which is the key comparison: the program’s value was speed beyond what breakthrough and priority review already give. Companies filing next should model standard timelines until FDA publishes guidance.
📰 Source · BioSpace ↗ FDA’s commissioner voucher program reportedly shuttered ahead of Senate vote on Overton