Legal and safety questions mount over FDA expedited drug voucher program

The Food and Drug Administration’s new Commissioner’s National Priority Voucher program, which promises approvals “in as little as one month” for medicines tied to “U.S. national interests,” is drawing internal alarm and legal uncertainty at the agency even as it moves forward with a slate of fast‑tracked reviews.

The program, announced by Commissioner Marty Makary and backed by the White House as aligned with President Donald Trump’s priorities, has designated 18 medicines for expedited treatment. Most of the reviews are slated to begin in 2026, with two scheduled for later years, and so far a single generic antibiotic has completed the pathway. Agency staff and documents describe a tension between aggressive timelines and the FDA’s traditional multi‑month scientific review process.

Seven current or recently departed FDA staff members told reporters on condition of anonymity that the initiative is causing anxiety, confusion and new upheaval in a drug center already strained by layoffs, buyouts, retirements and resignations. The center has lost roughly one in five employees in recent personnel actions and has cycled through multiple directors; officials now say it is being led by its fifth director in the past year. Staffers said some reviewers assigned to a highly anticipated anti‑obesity application were told they could omit certain regulatory steps to meet the program’s aggressive deadlines.

Legal authority over sign‑off for approvals under the voucher pathway is a central point of contention. Traditionally, approval decisions have been signed by review scientists and their immediate supervisors, but internal discussions show uncertainty about whether political appointees or senior leadership should have final authority under the new pathway. Then‑drug director Dr. George Tidmarsh declined to sign approvals under the program and resigned from the agency in November. After he left, Sara Brenner, the agency’s principal deputy commissioner, reportedly declined sign‑off power after reviewing the legal implications. Responsibility is now being handled by Dr. Mallika Mundkur, the agency’s deputy chief medical officer, who “works under Prasad.”

Internal agency documents and scientists also show that reviewers have paused or reexamined some fast‑tracked applications when safety or efficacy issues emerged. Reviewers asked for a two‑week delay in one application for an experimental therapy for a rare blood disorder after questions surfaced about trial data, potential risk for abuse and a reported patient death. In another case reviewers raised statistical and efficacy concerns about a trial’s secondary measure described as “pain‑free time in the sun” and considered whether biomarker data might instead justify authorization. Scientists also examined whether the investigational drug bitopertin posed abuse risks that could alter its regulatory pathway or require restrictions.

Health and Human Services spokesman Andrew Nixon defended the program, saying it prioritizes “gold standard scientific review” and aims to deliver “meaningful and effective treatments and cures.” Some outside experts welcomed the agency’s decision to delay reviews when problems appeared, viewing such pauses as evidence that the FDA may still withhold market authorization when warranted. That view was summed up by Holly Fernandez Lynch of the University of Pennsylvania, who called the delays “a very good sign.”

Even so, agency staff and outside critics warn that redirecting major approval decisions toward political leadership or accelerating reviews without clear legal and procedural guardrails could undercut the FDA’s scientific standards, damage its reputation and pose safety risks for patients. With leadership turnover and staffing reductions compounding the challenge, the voucher program’s one‑ to two‑month target remains the focal point of a debate over speed, law and public health.