I’ve been blogging about FDA Commissioner Markay’s National Priority Voucher program since it was announced in June 2025 (here, here, here, here, and here). In these blogs, I’ve raised the following concerns:

  • The compressed one- to two-month timeframe creates a potential opportunity for missing something important during these reviews.
  • With the competition for resources for regular NDA and BLA submissions, National Priority Voucher submissions will likely disadvantage some sponsors. How much strain will the voucher applications place on the current review paradigm and will standard PDUFA goals be negatively impacted by the program? Remember, if everything is first, nothing is first!
  • Recently, the industry has been surprised by an increase in the number of complete response letters (CRLs) being issued for NDAs and BLAs, and has seen more goal-date extensions for the FDA to complete its review of applications. If these CRL and review-extension metrics worsen in response to the voucher program’s resource requirements, it will be interesting to see how the industry reacts.
  • There have been concerns raised within the Agency and in Congress regarding drug products reviewed and approved through the FDA’s accelerated approval process based on surrogate endpoints and the applications that received full ten- to twelve-month reviews. What if a voucher is issued for a drug product for which the approval will be based on a surrogate endpoint?
  • The criteria for selection of voucher awards have not been fully vetted.

 

Others, apparently, agree that there are some significant unanswered questions about the program that need to be addressed, some of which are outlined in an article (here), published today by Axios and titled “FDA chief’s bid to speed drug reviews hits turbulence,” which focuses on the Commissioner’s National Priority Voucher program. In it, Axios outlines some additional points of concern expressed by members of Congress as well as former FDA senior staff.

The article states, “[c]ritics say the criteria and process for obtaining the vouchers are opaque and driven by political appointees, not career staff, raising the prospect of favoritism.” Axios points out concerns from lawmakers about the potential for favoritism and corruption in the process that was raised by Rep. Frank Pallone (D-NJ) and Sen. Bernie Sanders (I-VT) in a letter sent to the FDA Commissioner. Additionally, others have raised the question of the legality of the program since it has not been written into law or regulation as have the other expedited-review programs that the Agency currently has in place.

However, Axios also points out the opposing view that the program is forward-looking and addresses how the FDA can speed up review times for applications for promising drugs that meet national priorities. Sure, it would be nice if the FDA could approve a drug in a couple of months, rather than the years it sometimes takes in the standard review process, but at what cost? It would also be nice if generic drugs, which are duplicates of brand-name drugs, were approved in a shorter time frame than NDA or BLA products since there are no new clinical studies involved. However, the FDA has had a difficult time shortening reviews and improving first-cycle approval times for generics. Maybe the Commissioner should look at improving generic-drug review and approval times as a way to bring down existing drug costs.

Speaking of costs, it’s been a long-held principle that the FDA does not take cost into consideration when reviewing drug products. This ethic was in place when I joined the Agency in 1984 and we had it drilled into our minds from day one. While I know that the FDA has taken some liberties about taking enforcement actions for unapproved marketed drug products when a “grandfather drug” was brought under the regulatory umbrella by a first NDA approval, such instances were exceptions rather than the norm. Now, however, from statements the Commissioner has made, it appears that drug cost may come into play in decisions in relation to his voucher program.

As the Commissioner’s National Priority Voucher program moves forward, now with nineteen drug products selected or under consideration, there are sure to be additional questions about the program that need to be answered.