The FDA issued a News Release (here) that provides some additional information about the program. “‘Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,’ said FDA Commissioner Marty Makary M.D., M.P.H.” That begs the question, what happens if the study fails its endpoints? Will the FDA’s review of material submitted prior to the study’s completion have been a waste of Agency resources? I guess that’s what the pilot program will flesh out.
In the first year of the program, the FDA will give out a limited number of these vouchers to companies that have products aligned with national health priorities, which, at this time, include:
- Addressing a health crisis in the U.S.
- Bringing potential innovative therapies to the American people
- Addressing unmet public health needs
- Significantly increasing the national security of the U.S.
Unlike other types of priority review vouchers, the Commissioner’s National Priority Vouchers are not transferable and cannot be sold.
The vouchers also have a two-year expiration date so you must use them or lose them. The Agency discusses some other features of these vouchers here but, according to this Q&A document, more detail will be forthcoming prior to the pilot program’s initiation.
