According to the FDA, the program is aimed at companies whose projects can contribute to, for example, combating antibiotic resistance, improving public health emergency preparedness or promoting production of critical substances in the country. Vouchers are awarded to selected companies and provide access to a fast track where a regulatory assessment can be completed in as little as 60 days – significantly shorter than the normal interval of up to a year.
In a press release, the FDA Commissioner said Marty Macary that the program allows a company to submit most of an application before a clinical study is completed. To qualify for the fast track, the company must submit the chemistry, manufacturing and controls (CMC) section, as well as proposed labeling, at least two months in advance of the application. While applications are currently sent between multiple FDA departments for review, the new fast track means that the agency brings together experts from different units. A multidisciplinary team of doctors and scientists reviews the clinical information in advance, and then a one-day meeting is held for a comprehensive assessment.
Pilot program with focus on efficiency
The CNPV program is initially being launched as a pilot project with a limited number of vouchers. These will be non-transferable and valid for up to two years. The FDA emphasizes that this is not about lowering safety or efficacy standards.
- This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time. We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation, said the FDA Deputy Commissioner General Sara Brenner, in a press release.
The focus is on increasing the FDA's efficiency and supporting the development of projects of particular societal relevance. According to the FDA, the program targets companies whose projects are aligned with the United States' national health priorities, i.e. projects that aim to address a health crisis in the United States, to deliver more innovative treatments to the American people, to meet unmet public health needs, and to increase domestic pharmaceutical manufacturing as a matter of national security.
It is worth noting that the new fast track is being introduced at the same time that the Trump administration is implementing significant staff cuts at the FDA.
