FDA adds information on Commissioner’s National Priority Voucher program

Background on the CNPV program

Last month, FDA announced a “Commissioner’s National Priority Voucher” (CNPV) program, which the agency said at the time would provide a “limited number” of vouchers to sponsors of drug products that are “aligned with U.S. national priorities.” We previously summarized online here who may be eligible for a CPNV, along with the benefits of a CNPV, based on FDA’s press release and FAQ website published in June.

The CNPV pilot program promises a significant opportunity to reduce drug and biologic review times from 10-12 months to 1-2 months. Companies selected for the program will be issued a voucher entitling the company to benefits including enhanced communications and rolling agency review. In June, FDA had said vouchers would be given “to companies aligned with U.S. national priorities,” including:

1. Addressing a health crisis in the U.S.
2. Delivering more innovative cures for the American people.
3. Addressing unmet public health needs.
4. Increasing domestic drug manufacturing as a national security issue.

FDA has now identified a fifth priority of “[i]ncreasing [a]ffordability.” The idea that drug affordability may factor under the CNPV program had been floated by the Commissioner in interviews subsequent to the original program announcement, but it has now been made concrete, as we discuss below.

New information about the program

On July 22, FDA released additional information on its web page clarifying certain aspects of the program. Although the new post primarily reiterates previously disclosed information, we identified the following notable changes:

1. Program priorities. As stated above, FDA previously cited four “national priorities” for which a CNPV may be eligible. FDA has added brief descriptions of these four priorities and added a fifth priority of increasing affordability:

• Addressing a U.S. public health crisis. FDA states that an “example could include developing a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential.”
• Delivering more innovative cures for the American people. FDA explains that the “focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation,” offering the examples of creating a novel immunotherapy that reprograms the body's immune system to fight multiple diseases or transforming mental health care through a novel treatment for PTSD.
• Addressing a large unmet medical need. FDA explains that this could include “a condition that available therapies do not adequately diagnose or treat, including drugs to treat or prevent rare diseases or addressing America’s chronic disease crisis.”
• Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency. FDA clarifies that examples “could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the U.S.; or a clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care.”
• Increasing affordability. FDA explains that this could include a company that lowers the U.S. price of drugs “consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs.”

2.Up to five selections. The agency previously wrote that FDA plans in the first year of the program to give a “limited number” of vouchers to companies aligned with U.S. national priorities; now, FDA specifies that it will issue “no more than five” vouchers in the first year of the program. In addition, FDA specifies that “companies are limited to submitting one application” for the program in its first year.

3. CNPV application instructions. FDA’s new web page explains that an application for a voucher should include a brief description – of “350 words or fewer” – explaining how a company’s drug or biologic development program aligns with the pertinent national health priority. The agency specifically urges applications to include:

• information about the targeted disease or condition;
• the potential impact of a drug;
• the current stage of development (with clinical data highlights as relevant);
• any unique aspects of the approach that make it particularly relevant to the chosen priority; and,
• any specific issue(s) for which a sponsor is seeking enhanced communications with FDA to facilitate program development.

4. Biologics included. Although FDA’s June announcement about the CNPV program omitted any mention of biological products, the new web page clarifies in multiple instances that this is an opportunity for both “drug and biologic developers.”

5.Regulatory authority. FDA also affirmed that it has the authority to implement this program under “its general authority to implement the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) consistent with its mission to promote and protect the public health,” including with respect to review of new drug applications and biologics license applications.

Next steps

As we observed last month, the program’s announcement leaves many questions unanswered, including whether (and if so, when) FDA will publish more detailed guidelines on qualification criteria, and how these abbreviated FDA reviews will operate in practice. We continue to anticipate legal challenges to FDA’s grants and denials of these vouchers. Because these vouchers will be immensely valuable to the receiving companies, and because FDA will only be issuing up to five of them in the first year, we expect implementation of the new policy to result in litigation.

If you have any questions regarding the CNPV program, or regarding clinical trials and FDA approval standards more generally, please feel free to contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Robert Church, Komal Nigam, Susan Cook, Jason Conaty, and Eva Schifini.