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# Makary’s FDA Voucher Program Questioned
- URL: https://www.fdaweb.com/makarys-fda-voucher-program-questioned/
- Published: 2025-06-24T12:00:00.000Z
- Updated: 2026-09-14T15:15:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159407

University of Pennsylvania Perelman School of Medicine associate professor of medical ethics and law **Holly Lynch** says the new FDA [Commissioner’s National Priority Voucher](https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests?ref=fdaweb.com) (CNPV) program raises the question of how fast is too fast for FDA drug review. Writing online for *MedPageToday*, Lynch [says](https://www.medpagetoday.com/opinion/second-opinions/116218?ref=fdaweb.com) a deeper look at commissioner **Martin Makary**’s voucher program shows that some of the elements are so aligned with the “common sense” approach promised by Makary that the agency already has been using them for years. Other elements, she says, require commitments to adequate resourcing and transparency that have not yet been forthcoming.

“Overall,” Lynch writes, “while efficiency is important, the program raises concerns about the minimum time needed to achieve adequate review of drug safety and effectiveness.”

While Makary has said the new voucher program is a response to concerns that FDA regulatory requirements have made the U.S. less competitive in the global race for new drugs and treatments, Lynch says the reality is that the agency approves most novel drugs before they are approved anywhere else.

“Recent data indicate that FDA’s median time between application submission and approval letter for priority review drugs is just over eight months, accounting for the filing period,” Lynch writes. “Given the extent of information included in each application and the in-depth nature of FDA’s reviews, this is a remarkable feat. Yet, Makary has posited that FDA’s entire review could be condensed into the period currently allotted to determining whether to simply file the application. How could that be?”

She says Makary proposes using the “idle time during clinical trials” for sponsors to submit and FDA to review most elements of an application. She notes this already occurs through rolling applications for drugs given fast track and breakthrough therapy designations, and under Real-Time Oncology Review and the Split Real Time Application Review pilot.

“If existing programs haven’t gotten FDA review times down to one to two months, can the CNPV program really do better?” Lynch asks.

She says that while Makary says the agency’s new artificial intelligence tool “Elsa” will help cut review times, initial reports have raised concerns about its reliability. “Even if the kinks are ironed out,” she says, “efficiency gains from AI may be negated as FDA reviewers are stuck managing added workloads following unprecedented agency layoffs and departures…. Already, there have been reports of missed deadlines resulting from FDA’s ‘heavy workload and limited resources.’”

The resource concerns could also affect Makary’s promise for real-time communication with FDA reviewers as part of the voucher process, Lynch says. She points out that some expedited programs already facilitate communication and that such efforts require sufficient resources that must grow in proportion to increased demands. “So far, that common sense element is missing from the CNPV discussion,” she says.

Lynch also questions who will staff the review teams envisioned in the CNPV and whether political staff will be involved in selection or even serve as reviewers. “Will CNPV teams be willing to question sponsors or seek more information if it means slowing down a decision?” she asks. “Will they listen to career staff who raise concerns? These will be critical elements to watch.”

Also still to come, Lynch says, is information on which sponsors will receive vouchers and whether the vouchers will end up being political favors available only to sponsors that align with the current administration and FDA leadership.

“There are many more questions about the CNPV program,” Lynch concludes, “but the most foundational is this: how fast is too fast for reasonable FDA drug review? To be sure, speed is important to both patients and sponsors, and there are certainly existing inefficiencies. But suggesting that there are regularly six months of wiggle room in important FDA reviews that prior administrations have missed is a tough pill to swallow. Far more plausible is that speed will be traded for review quality and confidence, despite protestations to the contrary, or that FDA’s current leadership will come to the common-sense realization that current reviews are remarkably fast and that quality review takes time, resources, and stability. Let’s hope they start focusing on building the latter.”