Inside the FDA, alarm grows over fast‑track voucher program and safety risks

Senior officials and frontline reviewers at the Food and Drug Administration raised alarm internally as an expedited voucher program intended to speed drug approvals expanded beyond its original pilot and began pressing reviewers to meet sharply shortened timelines, according to agency records and a congressional letter. The program, launched by Commissioner Marty Makary as the Commissioner’s National Priority Voucher program, promised review windows as short as one or two months for medicines the agency deemed aligned with “U.S. national priorities,” far shorter than the six-month statutory benchmark for priority review.

What began as a small pilot capped at five drugs was scaled up. A House Energy and Commerce Committee letter dated Nov. 20, 2025 noted that 15 vouchers had been awarded as of Nov. 6, 2025; later reporting indicates the total rose to 18. Companies awarded vouchers may wait up to two years to submit applications, and several firms said they were surprised to learn they had been selected for the program, the letter said.

Internal agency records and mid-January reporting show that reviews of at least two CNPV-selected drugs were delayed after agency scientists flagged safety and efficacy concerns. One delay followed scrutiny of trial data for an experimental therapy from Disc Medicine for a rare blood disorder, including review after a patient death while taking the medicine. Reviewers also examined whether the experimental drug bitopertin presented abuse risks and whether surrogate or biomarker endpoints were statistically sound measures of benefit.

Current and former staff described to colleagues and oversight officials how the program’s compressed timelines omit the customary 60-day prefiling period and create pressure to accelerate or skip standard review steps despite incomplete data. That dynamic, critics say, threatens the scientific rigor that underpins public confidence in approvals and could increase the risk of harm to patients, particularly those in communities already underserved by the health system.

The Office of New Drugs has experienced notable turnover during the rollout: sources report roughly 20 percent staff losses in the drug center and the appointment of a fifth director in the past year. Longtime official Richard Pazdur left the agency in December; he and other senior observers have attributed departures to broader concerns about politicization, transparency, and responsiveness to reviewers’ safety warnings.

Legal and ethical questions have multiplied. A House Democrats’ letter warned the program lacks clear criteria and statutory authorization and could create avenues for political influence or the appearance of favoritism. Legal experts inside and outside the agency have cautioned that hurried decisionmaking could invite litigation over labeling and postmarket liability and complicate determinations about which adverse events must be disclosed to patients and clinicians.

Some industry executives said they would decline to seek a voucher, fearful that approvals obtained under the program could be vulnerable to reversal or legal challenge if the pathway does not survive political change. Public health advocates warned that tying regulatory prioritization to concurrent White House pricing announcements risks disadvantaging treatments for marginalized populations whose conditions lack political or market attention.

A Health and Human Services spokesman defended the initiative, saying it seeks to preserve “gold standard scientific review” and to deliver “meaningful and effective treatments and cures.” The agency has delayed some CNPV reviews while staff examine safety, efficacy, and abuse potential. As the program unfolds, regulators must weigh faster access against the public’s need for reliable, transparent science that protects patients and preserves equity in health care.