Since its introduction nine months ago, the FDA’s national priority voucher pilot program has attracted intrigue and fierce criticism while also yielding several rapid drug approvals. With all of this buzz surrounding the program, the agency is only now planning to solicit public feedback and consider any potential tweaks.
The FDA has scheduled a public hearing for June 12 to hear input on the Commissioner’s National Priority Voucher (CNPV) program, an initiative it introduced last June. Alongside the in-person event at the FDA's headquarters in White Oak, Maryland, commenters have a chance to voice their CNPV feedback virtually—both before and after the event and during the hearing.
The CNPV program, which seeks to prioritize drug reviews for products that align with vague "national interests," has attracted high-profile criticism and spurred internal strife at the agency. Under the CNPV pathway, the agency seeks to make drug approval decisions within one to two months, far shorter than the six months for its priority reviews and 10 months for standard reviews.
The agency says it considers CNPV reviews for products that address a public health crisis, introduce an innovative breakthrough, target large unmet needs, bolster domestic manufacturing or improve drug affordability.
The program wasn't introduced through Congress, and two lawmakers have shared "deep concerns" that it could "enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump."
In addition, the lawmakers shared a worry that CNPV reviews could be "rushed" and "undermine public confidence in FDA's decisions."
Officials from several FDA offices will participate in the public hearing, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Oncology Center of Excellence.
With the hearing, the FDA wants to "seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation," according to the Friday announcement.
When the FDA unveiled the pilot program last year, it was difficult to tell exactly what would become of the initiative. Since then, the agency has doled out 18 ultraspeedy drug reviews—including assigning one proactively based on impressive study data—and awarded CNPV approvals to Novo Nordisk, Johnson & Johnson, Boehringer Ingelheim and USAntibiotics.
The CNPV program has also witnessed a drug rejection, with Disc Medicine's rare blood disease candidate bitopertin failing to make the grade last month.