The U.S. Food and Drug Administration (FDA) reportedly delayed reviews of several drugs selected for the Trump administration’s new fast-track approval program, after agency scientists raised concerns about safety, efficacy, and trial data, according to internal documents reviewed by Reuters.

The FDA’s Commissioner’s National Priority Voucher (CNPV) program is to expedite drug review processes for products aligned with critical U.S. national health priorities. Review times would go from 10 to 12 months to just one or two months.

The pilot program has 16 drugs under review.

In December 2025, Merck & Co. Inc. (NYSE:MRK) cholesterol treatment enlicitide decanoate and cancer therapy sacituzumab tirumotecan (sac-TMT) have been reportedly selected for the CNPV program.

If finalized, the drugs would become the 17th and 18th to enter the program, according to internal documents reviewed by Reuters.

Drugs Impacted

FDA reviewers postponed their decision on an experimental treatment from Disc Medicine Inc.