The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors that align their development activities with specific US national interests.
In a recent updated program page and revised FAQs, FDA provided greater clarity on eligibility criteria, application procedures, and agency expectations. Notably, FDA reaffirmed that only sponsors whose product development activities “demonstrate alignment with one or more” of the program national interests will be eligible. This voucher promises expedited review of a specific investigational new drug and enhanced access to agency officials.
Overview of the CNPVP
According to information released about the program to date, companies may qualify for a voucher if their drug development activities align with specific stated US national interests, including:
- Increasing US-based drug manufacturing
- Addressing a national public health crisis
- Addressing unmet medical needs
- Delivering innovative therapies for the American people
- Increasing affordability
While details on the program from FDA remain slim, key benefits of the program appear to include faster review times (with FDA promising review timelines of as few as one to two months), enhanced agency communication, and a multidisciplinary team–based evaluation that appears to differ from standard new drug application or biologics license application review teams and review approaches.
FDA may also be requiring that applicants in the pilot program submit chemistry, manufacturing, and controls (CMC) data and draft labeling at least 60 days prior to filing a final marketing application to enable staggered review of the application.
To be considered, a sponsor must submit a preapplication request including an identification of the national interest that the proposed drug development program would address and a brief description of how that program would work to address the priority. Importantly, FDA notes that companies are limited to submitting a single application.
CNPVs are nontransferable and must be used within two years of issuance. Under the program, FDA may grant either
- designated vouchers attached to a specific product at the time of award; or
- undesignated vouchers, allowing sponsors to later assign the voucher to a qualifying product in their pipeline.
FDA has stated that it intends to select no more than five programs for the CNPVP during its initial year.
While traditional priority review voucher programs target more specific areas of drug development need (e.g., treatments for underserved or limited populations or rare diseases), the CNPVP is grounded in broader national interests. The CNPVP appears to be positioned as a regulatory roadmap for rewarding companies that proactively align their research and development efforts and manufacturing priorities with stated national interests.
What CNPVP May Mean for Industry
For drug and biologic developers, the CNPVP introduces the following considerations:
Increased Need for Strategic Foresight
While FDA has now issued more detailed eligibility standards and illustrative examples, sponsors should continue to monitor FDA communications for ongoing updates as the CNPVP matures. While industry awaits more guidance, companies that act early can potentially help shape implementation norms. In any case, monitoring future FDA communications will be critical for staying ahead of the agency’s evolving expectations. FDA also notes that sponsors may be required to engage in preliminary dialogue with the agency prior to submitting a formal application for the voucher.
Business Strategy and Product Prioritization
To take advantage of the CNPVP, companies may have to proactively adjust development timelines to ensure early readiness for CMC data and draft labeling submissions. Additionally, companies may need to reassess their development pipelines to prioritize products that can be credibly positioned as advancing the specifically highlighted national interests.
Looking Ahead
The CNPVP represents a notable shift in how the FDA leverages regulatory. While it introduces some uncertainty due to broad eligibility standards and a case-by-case review, it also provides a unique opportunity for companies to align innovation with national interests and potentially benefit from expedited access and review.
With relatively slim information from the agency on the program giving sponsors limited predictability, the need for proactive engagement and careful monitoring of further FDA guidance on the program will remain in place for some time to come.
For more information or assistance navigating the CNPVP, feel free to contact a member of our FDA regulatory team.