The FDA has begun accepting applications for a priority pathway designed to slash review times to between one and two months, giving developers of medicines that align with U.S. national health priorities a fast track to market.
FDA Commissioner Marty Makary, M.D., unveiled the program last month. Tuesday, the FDA opened the Commissioner’s National Priority Voucher (CNPV) pilot program for applications and fleshed out details of the scheme, including by providing more information on the types of products that may be eligible for the initiative and how the agency plans to accelerate regulatory reviews.
The FDA listed five priorities that products accepted into the scheme could address—up from four when the program was first announced—and provided examples of the types of medicines that could meet the CNPV eligibility criteria.
“Increasing affordability” is the newly added fifth priority. The FDA said a company could access the pilot via the affordability route if it “lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs.”
The FDA also revised the wording of a priority that covers domestic manufacturing. Under the updated priorities, the FDA is focused on “onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency.”
FDA officials cited “a clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care” as an example of a project that could meet the onshoring criteria. The FDA recently rejected a Roche request for approval over a lack of evidence on the effects of the drug in U.S. patients, and the agency has called for a higher proportion of local patients in studies.
The other three priorities are unchanged from the June notice, but the FDA has provided new examples. The agency named “a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential,” as an example of a product that could address a U.S. public health crisis.
Drugs that treat or prevent rare diseases or address “America’s chronic disease crisis” could meet one of the other priorities. The FDA also unpacked the priority to deliver more innovative cures, explaining that the aim “is transformative impact that far outstrips the threshold for breakthrough therapy designation.” Examples include drugs that reprogram the immune system to fight multiple diseases.
The FDA is asking companies that think they may meet the criteria to submit a description of 350 words or fewer of how the program aligns with one of the national health priorities. Companies should provide information about the disease, the potential impact of the drug, the current stage of development and any unique aspects of the approach that make it particularly relevant to the chosen priority.
FDA officials plan to pick up to five companies to participate in the pilot in the first year of the program. To accelerate reviews, the FDA will convene a senior, multidisciplinary review committee led by its Office of the Chief Medical and Scientific Officer. The FDA contrasted the model to its standard approach of sending applications to numerous offices staffed by reviewers who are “juggling competing priorities.”