Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not particularly appealing, as you might imagine. So time to grab that cup of stimulation and get started. Our choice today is salted caramel, a taste of the Jersey shore. Meanwhile, here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. And we will once again remind you that we changed our settings to accept postcards and telegrams. Back to the future, as they say. …
U.S. Food and Drug Administration leaders tried to quell staff and external concerns about a controversial new program to fast-track certain drugs at an employee town hall meeting this week, STAT reports. The program, called the Commissioner’s National Priority Voucher, was launched in June and allows the FDA to grant one- to two-month reviews to companies that prove their drugs “align with national priorities.” It has come under fire both internally and externally for allowing political officials to interfere with the drug review process. White House officials have used the program to reward companies that help achieve certain political goals. At least one voucher was awarded over the concerns of staff. And the program has alarmed career scientists, including the former director of FDA’s drug center, Richard Pazdur, who called the pathway “problematic” and warned reviewers were being shut out of the process, which could make drug review less rigorous.
Trump administration officials vetoed FDA plans to fast-track the review of a psychedelic treatment for severe depression, highlighting possible internal discord between senior leadership and the Make America Healthy Again movement, STAT explains. A psilocybin treatment from Compass Pathways made the agency list of promising medicines to be granted a speedy regulatory review. But when FDA Commissioner Marty Makary presented that list for sign-off to the U.S. Health and Human Services Department and to the White House in October, it was shot down. The veto came just hours before the FDA announced the first recipients of the Commissioner’s National Priority Vouchers. Of the 10 drugs the agency put forward, only the Compass medicine failed to make the final list. To some advocates of psychedelic medicines, the last-minute roadblock underlines an emerging disconnect between HHS Secretary Robert F. Kennedy Jr., a vocal proponent of the field, and other factions of the administration. Continue to STAT+ to read the full story…