Makary’s priority pathway charts new territory, linking regulatory decisions to national security

Biopharma executives applauded a pilot priority review pathway announced by FDA Commissioner Marty Makary Tuesday, anticipating streamlined reviews of innovative drugs, but some industry leaders, FDA officials and patient advocates privately expressed concerns.

In a sharp departure from other FDA programs aimed at advancing innovation, the commissioner’s national priority voucher (CNPV) will be available only to U.S. companies and will be awarded based on criteria that are not directly related to patient benefit. The role of a political appointee in selecting participants in the program is also a break with precedent. ...