US EditionUS FDA delays two drug reviews in new voucher program after safety, efficacy concerns
The FDA delayed reviews for two drugs in the National Priority Voucher program due to safety issues including adverse events and a patient death, raising concerns over fast-track approvals.
- On Thursday, the U.S. Food and Drug Administration delayed review of two drugs in the Commissioner’s National Priority Voucher program after safety concerns, including a patient death, were flagged.
- Initially framed as a small pilot, the program, launched by FDA Commissioner Marty Makary, has expanded from a cap of five drugs to 18 vouchers awarded.
- FDA reviewers say the timeline omits the standard 60-day prefiling period and staffers report pressure to skip review steps despite missing data.
- That staff turnover has left the FDA drug center with 20% staff loss and its fifth director in the past year, straining review capacity.
- The program is intertwined with White House pricing efforts and remains popular there, but former FDA officials declined sign-off amid legal questions about approval authority.
43 Articles
43 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…
Associated Press News
Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.
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.
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