STAT+: Drug companies, patient groups urge FDA to pause commissioner’s voucher program

STAT PlusPolitics Drug companies, patient groups urge FDA to pause commissioner’s voucher program At town hall, experts recommend agency formalize and clarify the speedy drug review pathway Manage alerts for this article Email this article Share this article By Lizzy LawrenceJune 4, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. WASHINGTON — Leaders at the Food and Drug Administration on Thursday listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary. The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback. Advertisement Makary launched the Commissioner’s National Priority Voucher program about a year ago, offering one-to-two month FDA reviews to companies that could prove their drugs “align with national priorities.” The priorities, which included addressing health crises and delivering innovative cures, were vague. Critics worried the process was vulnerable to political interference. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In drug development, FDA, legal, Pharmaceuticals, Policy Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. Newsletter The latest updates in federal health agencies, research institutes, and U.S. policy Recommended Pharma June 4, 2026 STAT Plus: Otsuka kidney drug slowed loss of function, but less than expected, in late-stage trial The Readout June 4, 2026 STAT Plus: AI titans push Congress for DNA safeguards Advertisement Adam's Biotech Scorecard June 4, 2026 STAT Plus: Does Revolution Medicines’ pancreatic cancer drug have even greater potential? First Opinion June 4, 2026 Grail’s multi-cancer early detection trial was negative. But as an oncologist, I see more to this story Biotech June 3, 2026 STAT Plus: Alnylam to partner with Inceptive Nucleics for AI foundation models for RNAi therapeutics Subscriber Picks