The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of frequently asked questions. The CNPV program aims to accelerate FDA’s review process for drugs that are aligned with national health priorities, as identified by FDA Commissioner Marty Makary. Dr. Makary described the CNPV program as reducing inefficiencies by harnessing a multidisciplinary, team-based model similar to the “tumor boards” used to discuss care options for patient cancer cases. FDA’s press release highlighted that frequent and enhanced communication with drug sponsors will increase efficiency without sacrificing the agency’s rigorous review standards.
How the CNPV Program Works
Rather than requiring numerous FDA offices to separately review a drug application, the CNPV program aims to convene a one-day meeting of experts who have pre-reviewed submitted information on each drug. Drug developers who redeem a voucher issued under the CNPV program could expect FDA review to take approximately one to two months, rather than the standard 10 to 12 months. Any type of drug, in any stage of development, can qualify for the CNPV program. FDA will determine which drug sponsors receive a voucher based on alignment with national priorities established by the Commissioner, which may include the following:
- Addressing a health crisis in the U.S.
- Bringing potential innovative therapies to the American people.
- Addressing unmet public health needs.
- Significantly increasing the national security of the U.S.
Timing of Program Implementation
FDA will begin issuing these new vouchers in 2025 as part of a one-year pilot phase and may increase the number of vouchers given after this pilot. Vouchers will expire two years following receipt from FDA. The agency intends to provide information “in the near future” on the application process and how companies can demonstrate their alignment with FDA’s national priorities.
Comparison to Other Accelerated Review Programs
The CNPV program is separate from and complimentary to existing accelerated approval and priority review programs, meaning that a single drug could potentially qualify for both accelerated approval and/or a priority review voucher, in addition to a voucher under the CNPV program. FDA notes that the new program aims to incorporate aspects of, but will not affect, pre-existing expedited review programs (e.g., fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation).
The new program is also separate from existing Priority Review and Priority Review Voucher (PRV) programs, which will continue as is. Unlike priority review vouchers, vouchers issued under the CNPV program cannot be sold or otherwise transferred to another company, though they will remain valid through changes in company ownership. Further, drugs in any area of medicine could qualify for the CNPV designation, while priority review vouchers are only available, pursuant to federal statute, to incentivize the development of drugs to treat rare pediatric diseases, drugs to prevent or treat tropical diseases, and material threat medical countermeasures.
Additional Considerations for Drug Developers
The national priorities identified by FDA to date are broad and could encompass a wide range of products. Further, the press release notes that FDA could direct these new vouchers toward a company’s specific investigational new drug or could grant a company an undesignated voucher for discretionary use that is consistent with programmatic objectives. Further details on the CNPV application process are forthcoming, but for now, FDA has noted that sponsors must submit the chemistry, manufacturing, and controls portion of the application and the draft labeling at least 60 days before submitting the final application. Further, sponsors must be available for ongoing and prompt communication with FDA during the CNPV review window.
Key Takeaways
The CNPV program appears to retain core aspects of FDA priority review programs. An even more condensed drug approval timeline will rely on enhanced communication between drug developers and the FDA and put more pressure on developers should unexpected issues arise during the approval process. Finally, developers interested in licensing or acquitting assets should remain conscious the non-transferable nature of the vouchers.