FDA Priority Review Vouchers unveiled at the second healthcare ramp round

Announcement

The FDA’s new Commissioner’s National Priority Voucher program for the first 15 awardees was under tangible succession pressure. The Commissioner’s National Priority Voucher (CNPV) was introduced in June, completing the first round of awardees to now. The program is planned to mitigate the duration for drug review from 10-12 months to a straight 1-2 months.

CEO of Disc Medicine, John Quisel, said, “It’s a very exciting and kind interactive activity to make people realise the responsibility with a tag of national and responsible priority holder to get this medication to the patient population. We can’t fail in this, right?”

Vouchers, an excitement among Healthcare leaders

The vouchers are offered to companies linked to the US national priorities involving those identifying the health crisis, unmet public health need or access; domestic drug manufacturing as a global security problem and serving more creative cures. On 16^th October 2025, the first 9 vouchers were issued. By now, the signals consist of infertility, type 1 diabetes, sickle cell disease, obesity and congenital deafness.

The companies that offered these vouchers are no more than big companies like Johnson & Johnson and no small as Disc that have a market capitalisation of around $3.24 billion in comparison to J&J’s worth more than $470 billion.

Quisel added, “At a time when the FDA put forth the proposals for CNPVs this summer, we felt that we had a potential rare disease, therapy and a peaking unmet medical need that’s identifying a spotted cause of disease. So that’s why we mentioned it in the application.”

While further explaining the industry’s drug candidate scenario for erythropoietic porphyrias (EPP), he said, “The Disc also holds positivity and support in communicating with the dermatology review division at the agency. It was essential to realise the rationality for a best of bid for one of these national priority vouchers granted to companies.”

The five vouchers are rooted in the company applications, among which four were selected by agency reviewers. The partner at the law firm Arnold and Porter, Eva Temkin, said, “Of the first nine awardees, there are a few very near to the end and the rest are still in Phase 3.” Five of the six vouchers declared in round two underwent therapies that are already on the market. This was declared quickly at the White House press conference to reveal a drug pricing official structure for GLP-1 medicines.