National Priority Voucher Program

In mid-2025, FDA Commissioner Dr. Marty Makary launched the Commissioner’s National Priority Voucher program, which was designed to cut FDA drug review timelines to one to two months for medicines deemed to support U.S. national health priorities — compared with roughly six months for accelerated approval and ten months for standard review. Makary framed the program as a way to apply “Warp Speed”-style urgency to the agency’s ordinary review work.

In an unusual move, the FDA itself selected nine experimental drugs for the program’s first round, announced October 16, 2025, rather than waiting for companies to apply. The first-round candidates included treatments aimed at vaping addiction, deafness, and pancreatic cancer. AP reporting noted that experts raised concerns that the program’s broad criteria give the FDA wide discretion over which companies benefit, creating the risk of favoritism.

Makary listed the voucher program among his signature reforms when he resigned on May 12, 2026. His successor’s handling of the program remains uncertain: deputy commissioner Kyle Diamantas became acting commissioner, and Heidi Overton has been nominated as the permanent successor, with a Senate HELP vote pending as of early October 2026. Whether the program continues at the same pace under acting leadership is an open question.

Timeline

• Mid-2025: Makary launches the Commissioner’s National Priority Voucher program, targeting 1–2 month review decisions for drugs serving national health priorities.
• October 16, 2025: FDA announces the first round of nine experimental drugs selected by the agency itself, including candidates for vaping addiction, deafness, and pancreatic cancer.
• May 12, 2026: Makary resigns as FDA Commissioner; Kyle Diamantas becomes acting commissioner.
• Early October 2026: Heidi Overton’s nomination as commissioner still awaits a Senate HELP Committee vote; the program’s future under new leadership is uncertain.