US EditionUS FDA delays two drug reviews in new voucher program after safety, efficacy concerns
FDA scientists raised safety concerns including adverse events and a patient death, delaying reviews of two drugs in the fast-track National Priority Voucher Program.
- On Thursday Reuters reported the U.S. Food and Drug Administration delayed review of two drugs in the Commissioner’s National Priority Voucher program amid safety and efficacy concerns, including a treatment‑related death.
- Initially framed as a small pilot, the FDA Commissioner Marty Makary unveiled the program's expansion to 18 vouchers, increasing pressure on the FDA drug center.
- The agency's standard 60‑day prefiling check was removed as FDA reviewers warned the accelerated timeline skipped critical information, and staffers said, `If the science is sound then you can overlook the regulations.`
- Questions about who can legally sign approvals prompted Dr. George Tidmarsh, FDA then-drug director, to decline sign-offs, and after others balked, Dr. Mallika Mundkur took over duties.
- The program's ties to White House pricing deals have drawn criticism, with outside experts including Dr. Aaron Kesselheim warning it may not survive and lacks scientific precedent, while Dan Troy notes Marty Makary holds broad discretion.
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38 Articles
FDA delays reviews for two drugs in new voucher program
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello hello! Hope you survived JPM week and are now recuperating with some electrolytes and a sleep mask. (But don’t forget our virtual recap later today.) Today, we discuss Trump’s lofty new health plan, see the FDA delay two drug reviews under the new voucher program, and more. Continue to STAT+ to read the full story…
FDA Shows Caution, Delays Trump-Backed Fast-Track Drugs Over Risks - Disc Medicine (NASDAQ:IRON), Eli Lilly and Co (NYSE:LLY), Sanofi (NASDAQ:SNY)
FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported patient death.
US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and efficacy concerns, including the death of a patient while taking one of the medicines, internal documents seen by Reuters show.
FDA Prioritization Program Stalls: Safety Concerns Cause Delays
FDA Prioritization Program Stalls: Safety Concerns Cause Delays The U.S. Food and Drug Administration has postponed the review of two drugs in its new fast-track initiative due to safety and efficacy reservations. These include Disc Medicine's treatment for a rare blood disorder and Sanofi's diabetes drug, Tzield, attributed with adverse effects, including patient deaths.Documents reveal these review delays were unexpected, with FDA reviewers ex…
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