STAT+: Drug companies, patient groups urge FDA to pause commissioner’s voucher program
Article excerpt
FDA Commissioner Robert Califf's voucher program, which grants pharmaceutical companies priority review of future drug applications as a reward for meeting regulatory goals, faces mounting pressure to pause. Drug manufacturers and patient advocacy groups are urging the agency to slow the initiative, citing concerns that the White House has weaponized the program to favor companies aligned with its political agenda. The vouchers, essentially fast-track approvals worth millions, have become a tool for rewarding industry behavior beyond traditional drug development metrics, raising questions about whether the competitive advantage compromises FDA independence or patient interests.
WASHINGTON, Leaders at the Food and Drug Administration on Thursday listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary.
The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.
Makary launched the Commissioner’s National Priority Voucher program about a year ago, offering one- to two-month FDA reviews to companies that could prove their drugs “align with national priorities.” The priorities, which included addressing health crises and delivering innovative cures, were vague. Critics worried the process was vulnerable to political interference.
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