Pharmalittle: We’re reading about FDA ‘expert panels,’ knock-off weight loss drugs, and much more

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Good morning, everyone, and nice to see you again after we took a bit of time off to tend to life and other sundry matters. We hope you thrived and prospered in our absence. In any event, now that we have returned, we are resuming our usual routine of foraging for interesting items and the like. And yes, this would be more difficult without a cup or three of stimulation. So as we fire up the shiny, new coffee kettle, we are pulling maple bourbon from the pantry. As always, you are invited to join us. Or simply grab a bottle of water if you prefer. Meanwhile, here are a few tidbits to get you started on your own journey today, which we hope is productive and meaningful. Best of luck and do keep in touch. We appreciate the tips and insights that you are able to share. …

Bypassing its standard pathways for scientific discussions, the U.S. Food and Drug Administration has recently held a slew of so-called “expert panels” that sidestep legal procedures and ethics guardrails, raising concern about cherry-picking of experts and evidence, MedPage Today tells us. The panels appear to be a new feature of Trump administration officials, and have no parallel in agency programs from years past, sources said. They are usually moderated by FDA Commissioner Marty Makary and FDA principal deputy commissioner Sara Brenner. There have been about four panels so far: one on selective serotonin reuptake inhibitors, or SSRIs, and pregnancy; another on hormone therapy for menopause; one on infant formulas, and another on talc in food, drugs, and cosmetics. At the recent meeting on SSRIs, for instance, rather than recruiting a wide range of experts to discuss the best data available, the FDA mainly invited clinicians and researchers who have a record of deep skepticism of antidepressants, including some who financially benefit from that skepticism, according to STAT.

Dozens of Congressional lawmakers are urging the FDA to crack down on the booming market for knockoff weight loss drugs amid mounting concerns over their potential safety risks, Bloomberg News writes. On Friday, a group of more than 80 bipartisan lawmakers asked the agency to stop counterfeit and copycat versions of GLP-1 drugs like Wegovy and Zepbound from flooding the market — a problem that emerged over the last year. The group asked FDA officials to ramp up enforcement over illegally imported weight loss drugs. They suggested issuing warning letters and better monitoring non-compliant online retailers and so-called compounding pharmacies that sell the medicines. The lawmakers also said the FDA should work in tandem with U.S. Customs and Border Patrol agents to stop Chinese entities from shipping unsafe weight loss drugs into the U.S. They requested an update on FDA efforts by July 30, given the “urgency” of the situation.