From 10 Months to 44 Days: FDA's Speed Push Is Already Working

The FDA fastest approval pathway is opening itself up to public scrutiny — and the early results suggest it actually works.

Commissioner Marty Makary National Priority Voucher pilot program, launched in June 2025, has awarded 18 vouchers and produced four approved drugs in less than a year, the agency announced Friday. Two of those approvals came in oncology, both delivered in roughly six weeks: one at 44 days after filing, another at 55 days, according to FDA. The standard FDA review timeline runs closer to ten months.

The agency published a Federal Register notice Friday seeking public comment on the program and scheduled a public hearing for June 12 at its White Oak headquarters, according to FDA. Makary framed the review as a chance to build on a successful first year. National priority vouchers are a game changer for patients waiting for life-changing therapies, he said. As with all of our new initiatives, we are seeking input on how we can better meet the needs of the American people.

The program works by awarding a nontransferable voucher to drugmakers whose products align with one or more national health priorities: bringing innovative therapies to patients, addressing large unmet needs, promoting domestic manufacturing, or increasing affordability. Recipients get enhanced pre-submission engagement, a multidisciplinary review council, and a target of one to two months from filing to decision — versus the conventional ten-month timeline.

One of the most recent approvals illustrates the speed differential. Boehringer Ingelheim Hernexeos (zongertinib) was filed on January 13 and approved 44 days later, on February 26. In clinical trials, 76% of previously untreated patients with HER2-mutant non-small cell lung cancer showed substantial tumor shrinkage, compared with a historical standard-of-care response rate of 30 to 45%. The drug was previously approved for patients who had received prior systemic therapy; the new approval extends it to first-line use.

The public hearing will examine program eligibility criteria, voucher selection processes, pre-submission requirements, and the role of the CNPV Review Council. Written comments are accepted through June 27. The question the FDA is trying to answer is not whether the program can move fast — the approvals demonstrate that — but whether the speed comes at the cost of thoroughness, and whether the domestic manufacturing hook is attracting investment or just adding friction.

For the pharmaceutical industry, the voucher is valuable precisely because it accelerates review for a single application of the company choosing. For Makary, it is a proof of concept that the FDA can be both rigorous and fast — a claim that has been easier to make than to demonstrate under previous administrations.

The June hearing will be the first structured opportunity for outside voices — patient advocates, drug developers, insurers, academics — to assess whether the program is delivering on its promises or creating new distortions. The comment period closes the day before.