FDA announced the first nine companies to be part of its National Priority Voucher program.¹

First announced in June of this year, the Priority Voucher program is a new initiative at the agency to promote novel treatments that FDA believes will benefit the health interests of Americans. This includes medications that meet a large, unmet need or reduce downstream health care utilization. Medications that will also utilize MFN pricing can be considered for the program as well.

What drugs are in FDA's National Priority Voucher program?

The first nine medications announced for the program are:

• Pergoveris for infertility
• Teplizumab for Type I diabetes
• Cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• Cenegermin-bkbj for blindness
• RMC-6236 for pancreatic cancer
• Bitopertin for porphyria
• Ketamine for domestic manufacturing of a critical drug for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic

In a press release announcing the drugs, FDA Commissioner Marty Makary, MD, MPH, said, “One of our core goals is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities. We must modernize the review process and try new approaches to meet the needs of the American people.”

As a part of the program, these drugs will receive a decision from the agency within 1-2 month once a complete application has been filed. Sponsors also receive enhance communication with FDA, who reserves the right to extend the review time should it find it necessary to do so.

The White House singled out Pergoveris’ maker EMD Serono for participating in the program.² The decision was made alongside EMD Serono’s announcement that it has struck a deal with the Trump administration to bring drug prices in line with the President’s MFN executive order. This includes participation in TrumpRx, where several medications will be available at discounted rates.

EMD Serono will also invest in domestic manufacturing facilities, which falls in line with the President’s other stated goals of increasing American manufacturing across a variety of industries.

In a statement,² President Trump discussed Pergoveris’ inclusion in the Priority Review program, saying, “Because we want more babies, to put it very nicely. And for this same reason, we will also allow new parents to deduct major newborn expenses from their taxes, so that parents that have a beautiful baby will be able, so we’re pro family. But the IVF treatments are expensive. It’s very hard for many people to do it and to get it, but I’ve been in favor of IVF, right from the beginning.”

The Priority Review program is a new initiative launched by the current administration. It was first announced in June of this year, where FDA explained that it would use a collaborative tumor board style review process to speed up review times.

In a statement issued at the time,³ Makary explained, “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public. As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”

More medications are expected to be added to the list.

Sources

1. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. FDA. October 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors
2. Fact Sheet: President Donald J. Trump Announces Actions to Lower Costs and Expand Access to In Vitro Fertilization (IVF) and High-Quality Fertility Care. The White House. October 16, 2025. https://www.whitehouse.gov/fact-sheets/2025/10/fact-sheet-president-donald-j-trump-announces-actions-to-lower-costs-and-expand-access-to-in-vitro-fertilization-ivf-and-high-quality-fertility-care/
3. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. FDA. June 17, 2025. Accessed October 17, 2025. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests