Industry group BIO and company Emergent BioSolutions are seeking clarity from the US Food and Drug Administration (FDA) on certain aspects of the agency’s recently released draft guidance on medical countermeasure priority review vouchers (PRVs).
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 PRVs 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 a 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.
While applauding FDA for saying it would be willing to provide applicants with a preliminary, nonbinding opinion on whether an application may qualify for a PRV, BIO called on FDA to provide more clarity in terms of a specific timeframe on when such a preliminary opinion may be rendered.
The draft also notes that to obtain a PRV, the material threat must be listed at the time of the application’s approval on the annual Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategic Implementation Plan.
But BIO noted that the PHEMCE plan contains a list of high-priority threats and those items on the list that are also designated by the secretary of the Department of Homeland Security as a material threat are marked accordingly.
“However, it is unclear if the PHEMCE threat list contains the entire DHS material threat list,” BIO’s comment said, while calling on the agency to reference the location where an updated DHS material threat list can be accessed.
“At a minimum, BIO seeks clarification on whether the threat list in the PHEMCE Strategic Implementation Plan is fully inclusive of the material threat list,” the comment noted.
Meanwhile, Emergent BioSolutions questioned whether FDA could provide more clarity on whether a combination product, when the primary mode of action is a device, would still be eligible for a PRV under this program.