BioPharma Dive August 25, 2025
Amy Baxter

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the drug approval process.

The Food and Drug Administration is pushing for faster drug reviews with an unconventional twist. As part of a new accelerated approval pathway, the agency will consider drug affordability as one of the priorities of its new voucher-based program, FDA Commissioner Marty Makary said last month.

Pricing scrutiny is a novel dynamic in the drug review process, which typically doesn’t include those kinds of questions. Makary’s focus on drug affordability wasn’t part of the original criteria laid out by the FDA when it first announced its new National Priority Voucher program in June, and its emergence leaves new...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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