FDA shelved the fast-track drug review initiative launched during the Trump administration by former Commissioner Marty Makary, according to six sources familiar with the matter and internal documents.¹

The Commissioner’s National Priority Voucher (CNPV) program was launched in June 2025, and was designed to slash drug review timelines to just one to two months for therapies addressing national priorities, such as urgent unmet health needs. The program was met with controversy however, as concerns rose over possible preferential treatment for companies meeting demands of President Donald Trump, such as offering drugs at lower prices.

Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, describes the program as “the worst of both worlds,” combining serious risks of political influence with potentially limited practical benefit, since many drugs might have qualified for other speedy review pathways.¹

The program was once touted as a bold fix for U.S. pharmaceutical regulation, but the program has instead been left adrift, mostly due to a lack of steady leadership at FDA, which has been without a permanent commissioner since May.¹ As of today, 22 total drugs have been given a voucher, while a dozen have been approved, including five since Makary left FDA in May.² Since Makary’s departure, no new drugs have received a voucher.¹

The program’s last big expansion came back in November 2025, when the agency extended the program to a total of 15 products that the agency says, “address critical public health and national security priorities.”³

A key component of the program was the executive council of political appointees who oversaw drug reviews and played a central role in speeding approvals, which has since reportedly gone dormant, according to internal documents.¹

Who sat on the council, and why did it draw criticism?

The program drew fierce criticism from regulatory experts over the handpicking of drugs and the makeup of the council, which included former acting drug center director Tracy Beth Hoeg and former biologics chief Vinay Prasad, Both of which left FDA earlier this year.¹ A source familiar with the process says companies were told by FDA leadership that the agency is not moving forward with the program but is keeping applications open, meaning when companies submit them, they simply don’t advance, according to the source.¹

Rich Danker, a former assistant secretary at the Department of Health and Human Services, says the initiative is quietly being phased out, pointing to the departure of the program’s top administrator, and notes that no new vouchers have been awarded.¹

HHS spokesperson Emily Hilliard says the pilot is ongoing and that FDA is reviewing feedback from a June public hearing on it to refine the framework. According to Reuters, the agency did not respond to requests for comment regarding the departure of the program’s lead or whether a new program coordinator had been appointed.¹

What’s happening to the drugs still moving through the program?

Of the two latest voucher applications for new drugs cleared since Makary left, Merck’s cholesterol pill Lipfendra and Revolution Medicines’ pancreatic cancer drug Rasonque, neither have been vetted by the executive council, according to documents.¹ For the nine drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources say.¹

Sources

1. US FDA shelves commissioner's voucher program for speedy drug reviews, sources say Reuters November 12, 2026, https://www.reuters.com/world/us-fda-shelves-commissioners-voucher-program-speedy-drug-reviews-sources-say-2026-11-12/
2. All of the Medications Announced as Part of FDA’s National Priority Voucher Program Pharmaceutical Executive October 17, 2025, https://www.pharmexec.com/view/medications-announced-fda-national-priority-voucher-program
3. FDA Continues to Expand National Priority Voucher Program Pharmaceutical Executive November 7, 2025, https://www.pharmexec.com/view/fda-expand-national-priority-voucher-program