FDA voucher program allowing White House to intervene, STAT reports

A new FDA fast-track drug review program is increasingly allowing the White House and senior agency officials to influence which medicines are reviewed most quickly, STAT’s Lizzy Lawrence reports. Although the FDA has traditionally insulated reviews from political pressure, top officials have overridden or pressured staff in awarding priority review vouchers, sometimes tied to White House drug-pricing agreements. FDA officials say the accelerated reviews tied to the voucher program are straining agency resources, forcing entire divisions to focus on single drugs like Disc Medicine’s (IRON) bitopertin. When staff sought an extension due to the tight timeline, senior official Vinay Prasad intervened and raised doubts about the drug’s effectiveness.