TBNHealth
STAT+: Pharmalittle: We’re reading about FDA shelving fast-track review, a Canadian importer arrested, and more
Publication: STAT
Author: Ed Silverman
Source published: 12/11/2026, 14:14:55 UTC
Briefing created: 13/11/2026, 04:56:42 UTC
Based on a feed excerpt; full article content has not been acquired. Source evidence retrieved 12/11/2026, 14:21:25 UTC.
Briefings
The U.S. Food and Drug Administration has officially shelved the fast-track drug review initiative launched under the Trump administration. This program, which aimed to reduce drug review timelines to one to two months for therapies addressing national priorities, was launched in June 2025. The initiative's core component, an executive council of political appointees, has become dormant since its former commissioner, Marty Makary, left office. The article also notes that the U.S. Senate health committee scheduled a pivotal vote for the nomination of Heidi Overton to serve as FDA commissioner, scheduled for November 18.
Key points
- The U.S. Food and Drug Administration has officially shelved the fast-track drug review initiative launched under the Trump administration.
- The executive council of political appointees that oversaw drug reviews and had a central role in speeding approvals has become dormant since its former commissioner, Marty Makary, left office.
Context
The initiative aimed to slash drug review timelines to just one to two months for therapies addressing national priorities, such as urgent unmet health needs. No new drugs have gotten a voucher since Makary's departure, and the program's key component has gone dormant. The U.S. Senate health committee has scheduled a pivotal vote for next week on the nomination of Heidi Overton to serve as FDA commissioner.
Limitations
The article provides specific dates and program details but does not supply additional background on the broader implications of the shelved initiative or the specific criteria for the executive council's dormancy.
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