> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mixed Stakeholder Views on Priority Voucher Pilot
- URL: https://www.fdaweb.com/mixed-stakeholder-views-on-priority-voucher-pilot/
- Published: 2026-07-08T12:00:00.000Z
- Updated: 2026-09-14T13:42:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161425

Responding to an FDA Request for Comments on the Commissioner’s National Priority Voucher pilot program, some stakeholders call for it to continue, perhaps with some changes. In contrast, others say it should be paused.

In its [response](https://www.regulations.gov/comment/FDA-2026-N-2366-0581?ref=fdaweb.com), Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports continuation of the program as a “voluntary, scientifically rigorous mechanism for accelerating patient access to safe and effective therapies in alignment with national priorities.”

PhRMA says that to ensure that the program is credible, sustainable, and scalable, FDA should consider the importance of providing greater transparency and predictability, including through regulatory formalization.

“If the program continues beyond the pilot phase,” the comment says, “PhRMA strongly encourages FDA to conduct notice-and-comment rulemaking to define voucher eligibility criteria, selection processes, operational expectations, and timelines, among other things. These rules would enhance the program’s transparency, effectiveness, consistency, and durability.”

The letter includes the association’s specific comments on voucher eligibility criteria, selection and nomination processes, regulatory requirements and engagement expectations, review timeline and process, program evaluation and future directions, and legal considerations. “Together,” PhRMA says, “these comments are intended to support FDA’s evaluation of the program and to inform potential refinements and additional guardrails that promote clarity, consistency, and confidence in the program’s operation.”

Approaching the issue from a different direction, Public Citizen [calls](https://www.regulations.gov/comment/FDA-2026-N-2366-0566?ref=fdaweb.com) on the agency to pause the voucher pilot, refrain from granting additional vouchers, and discontinue the program. It offers specific comments on these aspects of the program:

- creation of the voucher pilot without statutory authorization from Congress;
- unclear and changing eligibility criteria that include policy considerations unrelated to drug safety and effectiveness;
- review timelines of one to two months that are “unnecessarily and dangerously short”;
- inappropriate involvement of political employees and Center directors in voucher selection and the review of products receiving vouchers; and
- initiation of the pilot without notice-and-comment rulemaking.

“FDA’s established pathways to expedite the review of drugs and biologics can be effectively used to advance innovative therapies for serious and life-threatening conditions, unmet medical needs, and public health priorities,” Public Citizen concludes.

In its [response](https://www.regulations.gov/comment/FDA-2026-N-2366-0579?ref=fdaweb.com), Merck says it supports FDA’s objectives for the voucher program and that in its experience the program “has established earlier structured engagement between sponsors and FDA review teams, including timely input from subject matter experts and coordinated cross-agency interaction where appropriate, supporting alignment on development strategy and data expectations, particularly in chemistry, manufacturing, and controls, in advance of formal review.”

As FDA continues to evaluate the pilot, Merck says, continued clarity of expectations, consistency of implementation, sustained resourcing, and integration within established regulatory frameworks will be important to support the program’s scalability and sustained confidence.

Finally, the Association for Accessible Medicines [says](https://www.regulations.gov/comment/FDA-2026-N-2366-0534?ref=fdaweb.com) it strongly encourages FDA to include generics and biosimilars in the voucher program “as they are essential to achieving most of the identified national health priorities.” It also says FDA should formalize the criteria for the program and the procedures for accessing the program through regulation and guidance.