FDA reportedly shelves speedy drug-review voucher program

A Reuters report dated November 12 says the FDA has effectively shelved the Commissioner’s National Priority Voucher (CNPV) pilot, launched in 2025 under former commissioner Marty Makary to shorten some drug reviews to one or two months.

No new vouchers have reportedly been issued since Makary left in May. The political-appointee executive council overseeing the initiative has gone dormant, and sources say new applications are not progressing even though submissions remain open.

The pilot issued vouchers to 22 drugs; 12 have since been approved. Reuters reported that, for several, the program shortened approval timelines by eight months or more. Career FDA staff are reportedly handling timelines for the remaining participants.

It is not formally confirmed as terminated:
HHS says the pilot is ongoing while the FDA reviews public feedback and considers refinements. So “dead” is a fair description of its apparent current status, but the agency disputes that it has ended.

Sources:

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