The US Food and Drug Administration (FDA) on Wednesday released new draft guidance to help companies understand how the agency will award priority review vouchers (PRVs) for qualifying medical products to diagnose, prevent or treat diseases or conditions associated with chemical, biological, radiological and nuclear (CBRN) threats and emerging infectious diseases.
The draft, featuring 29 questions and answers on the new PRV program, is part of FDA’s implementation of the provision of the 21st Century Cures Act, which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review vouchers for material threat medical countermeasure (MCM) applications.
Similar to the two other PRV programs, if a sponsor wins approval of a material threat MCM application, the sponsor will also gain access to the PRV, which may be used by the sponsor to speed the review of another application by four months, or sold to another sponsor who may then use it.
FDA Commissioner Scott Gottlieb, testifying before the Senate Committee on Health, Education, Labor & Pensions on Wednesday, said the PRVs are needed to incentivize the development of these products, particularly as the only market for the products is the US government’s stockpile. In essence, the government pays companies to develop the products, win the PRV and then purchases the products.
FDA estimates there will be about two PRV requests under this program per year, according to a Federal Register notice.
The agency said it invites comment on the following topics related to the draft: "(1) whether the proposed information collected is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology."
Material Threat Medical Countermeasure Priority Review Vouchers: Draft Guidance for Industry