The U.S. Food and Drug Administration (FDA) reportedly delayed reviews of several drugs selected for the Trump administration’s new fast-track approval program, after agency scientists raised concerns about safety, efficacy, and trial data, according to internal documents reviewed by Reuters.
The FDA’s Commissioner’s National Priority Voucher (CNPV) program is to expedite drug review processes for products aligned with critical U.S. national health priorities. Review times would go from 10 to 12 months to just one or two months.
The pilot program has 16 drugs under review.
In December 2025, Merck & Co. Inc. (NYSE:MRK) cholesterol treatment enlicitide decanoate and cancer therapy sacituzumab tirumotecan (sac-TMT) have been reportedly selected for the CNPV program.
If finalized, the drugs would become the 17th and 18th to enter the program, according to internal documents reviewed by Reuters.
Drugs Impacted
FDA reviewers postponed their decision on an experimental treatment from Disc Medicine Inc. (NASDAQ:IRON) by about two weeks to February 10.
The drug, bitopertin, is being developed for erythropoietic protoporphyria, a rare blood disorder that causes extreme sensitivity to sunlight.
Regulators questioned whether “pain-free time in the sun,” a secondary endpoint in trials, was a statistically reliable measure of effectiveness or whether biomarker data could instead support approval.
During the first round of announcement, the agency noted that FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they deem appropriate.
Citing internal documents, the Reuters report on Thursday added that FDA staff responsible for evaluating drugs with abuse potential were asked to examine whether bitopertin posed any risk of misuse or addiction, adding another layer to the review process.
The agency also delayed its review of Sanofi SA’s (NASDAQ:SNY) Tzield (teplizumab), used in late-stage type 1 diabetes, by more than a month.
Documents cited by Reuters point to adverse event reports, including seizures, blood-clotting issues, and what regulators described as a treatment-related death.
The FDA’s public adverse-event database references a September 2025 case involving a 30-year-old man who experienced a seizure and other complications.
A Sanofi spokesperson told Reuters that the company carefully evaluates serious adverse events and continues to work closely with the FDA on Tzield’s expanded-use application.
Other drugs in the fast-track program have also seen timelines slip.
A decision on lung cancer drug zongertinib from privately held Boehringer Ingelheim is now expected in mid-February, while Eli Lilly and Co. (NYSE:LLY) said its weight-loss pill, orforglipron, could receive a decision in the second quarter, with current FDA guidance pointing to an April 10 target date versus late March anticipated earlier.
What Experts Say
Two regulatory experts told Reuters the delays were reassuring, noting that the program’s one- to two-month targets had raised concerns about whether reviews could remain thorough.
According to U.S. Representative Frank Pallone and Senator Bernie Sanders, the CNPV program is opaque. It risks favoritism, rushed reviews, and threats to public confidence, they argue.
Price Action: In premarket trading on Thursday, IRON shares slid 9.83% to $69.50, while LLY dipped 0.48% to $1,068.16 and SNY edged 0.50% lower to $47.65, at last check.
Photo by Tada Images via Shutterstock
Recent Comments