Two congressional figures, Rep. Frank Pallone Jr. and Sen. Bernie Sanders, sent a letter to FDA Commissioner Marty Makary raising 'deep concerns' about the agency’s new Commissioner’s National Priority Voucher (CNPV) program. The lawmakers argued the program lacks congressional authorization, meaningful transparency, and clear criteria, and warned it could create opportunities for political favoritism. The CNPV program grants winners ultrafast review meetings and shortened review timelines for products aligned with undefined national health priorities; winners have included major pharma names. Pallone and Sanders requested detailed explanations of the program’s governance, selection criteria, and safeguards against misuse. The inquiry adds policy risk to FDA’s experimental review initiatives and could prompt legislative or administrative changes if oversight gaps are confirmed.
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