Leaders from drug companies and patient groups urged the FDA to pause the Commissioner’s National Priority Voucher program during a White Oak listening session. The meeting followed criticism that one-to-two month review timelines are tied to vague national-priority criteria and could be vulnerable to political interference. The voucher program was launched by former FDA commissioner Marty Makary about a year ago, with the stated goal of accelerating reviews for therapies aligned with broad national priorities. Most speakers at the session recommended returning the program to normal regulatory pathways that include public feedback. The episode underscores heightened scrutiny over how the FDA sets review priorities and communicates what qualifies for expedited, short-cycle decision-making.
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