STAT+: Pharmalittle: We’re reading about FDA shelving fast-track review, a Canadian importer arrested, and more

The U.S. Food and Drug Administration (FDA) has suspended the fast-track drug review initiative initiated during the Trump administration, according to Reuters. Launched in June 2025, the Commissioner's National Priority Voucher program aimed to expedite drug review timelines to just one to two months for therapies addressing national priorities.

However, the program has faced criticism for potential preferential treatment of companies, such as offering drugs at lower prices. Since former Commissioner Marty Makary's departure, no new drugs have received a voucher and the executive council overseeing drug reviews has ceased operations.

The U.S. Senate health committee is scheduled to vote on Nov. 18 regarding the nomination of Heidi Overton to serve as FDA Commissioner. The vote would then move to the full Senate, where Republicans are attempting to confirm nominees before Democrats assume power in January. However, the vote's outcome could hinge on a single Republican's vote, as committee Chair Bill Cassidy (R-La.) has expressed uncertainty about Overton's nomination, depending on all Democrats voting against her.