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

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing a fresh cuppa stimulation and invite you to join us. Remember, a prescription is not required. Our choice today is ginger peach. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. … The U.S. Food and Drug Administration has shelved the fast-track drug review initiative launched during the Trump administration by former Commissioner Marty Makary, Reuters reports. Launched in June 2025, the Commissioner’s National Priority Voucher program aimed to slash drug review timelines to just one to two months ​for therapies addressing national priorities, such as urgent unmet health needs. But critics pointed to possible preferential treatment for companies meeting demands of President Trump, such as offering ‌drugs at lower prices. No new drugs have gotten a voucher since Makary’s departure, and a key component of the program — an executive council of political appointees that oversaw drug reviews ​and had a central role in speeding approvals — has gone dormant. The U.S. Senate health committee has scheduled a pivotal vote for next week on the nomination of Heidi Overton to serve as FDA commissioner, despite lingering doubts from Republicans on the panel, STAT writes. The vote is set for Nov. 18 and, if it passes, her nomination would then go to the full Senate, where Republicans are racing to confirm nominees before Democrats take power in January. But even as he scheduled the vote, committee Chair Bill Cassidy (R-La.) remained undecided on Overton, he wrote in a post on X. It would take just one Republican on the committee to sink her nomination, assuming all Democrats vote against her. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe