FDA Shelves Fast-Track Drug Review Initiative

According to internal documents and close sources, the US Food and Drug Administration (FDA) has shelved the fast-track drug review initiative launched during the Trump administration.¹

The Commissioner's National Priority Voucher program, created by former Commissioner Marty Makary, which launched back in June 2025, aimed to reduce drug review timelines to just 1 to 2 months for treatments that addressed national priorities, like the mental health crisis. President Trump further accelerated the process for therapies addressing the mental health crisis when he issued an Executive Order on April 18, 2026, that directed the US Department of Health and Human Services (HHS) to accelerate access to treatments for patients with serious mental illness. Amongst the top candidates were psychedelics such as psilocybin for treatment-resistant depression and major depressive disorder, and methylone for posttraumatic stress disorder (PTSD).^2,3

No New Vouchers

While previously lauded as a solution to US pharmaceutical regulation hold ups, the program has floundered following internal upheaval at the FDA. Notably, the FDA has been without consistent leadership since Makary’s departure in May, leaving no commissioner to take the helm of this initiative.

Under the active program, there were 22 drugs given a voucher, and only a dozen of those were approved. For several of those drugs, the program quickened approval by 8 months or more.

No new drugs have received a voucher since Makary's departure. The executive council of political appointees that oversaw drug reviews and assisted in speeding approvals has also gone dormant, according to internal documents. Furthermore, one source shared that pharmaceutical companies were informed by FDA leadership that the agency is not moving forward with the program but will keep applications open; the companies can submit, but they will not advance.

Rich Danker, a former assistant secretary at the HHS, said the initiative is quietly being phased out and new vouchers have been awarded.

Emily Hilliard, a HHS spokesperson, said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing on it to refine the framework.

The fate of the 9 drugs still in the program hangs in the balance, though according to 2 sources, FDA career scientists have resumed overseeing review timelines.

Complaints

The program drew fierce criticism from regulatory experts. There were complaints about (1) handpicking of drugs, (2) the makeup of the oversight council, (3) preferential treatment for companies meeting President Trump’s demands.

• Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, described the program as “the worst of both worlds.” She claims it combined serious risks of political influence with potentially limited practical benefit since many drugs might have qualified for other review pathways.
• Peter Lurie, a former FDA executive, criticized the program for ceding review decisions to political appointees, which risks consumer safety with compressed timelines, and for lacking transparency.

References

1. Wingrove P, Abutaleb Y. US FDA shelves commissioner's voucher program for speedy drug reviews, sources say. Reuters. November 12, 2026. Accessed November 12, 2026. https://www.reuters.com/world/us-fda-shelves-commissioners-voucher-program-speedy-drug-reviews-sources-say-2026-11-12/

2. Duerr HA. FDA fast-tracks psychedelic therapies for depression, PTSD, and alcohol use disorder. Psychiatric Times. April 24, 2026. https://www.psychiatrictimes.com/view/fda-fast-tracks-psychedelic-therapies-for-depression-ptsd-and-alcohol-use-disorder

3. FDA accelerates action on treatments for serious mental illness following Executive Order. News release. April 24, 2026. Accessed November 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order