February 22, 2025 — It’s official. FDA yesterday declared that the semaglutide shortage is over and now we wonder how quickly and completely the compounding of obesity medicines will vanish. From the very first days of launching semaglutide for obesity in 2021, demand has outstripped supply. The FDA officially declared the shortage in March 2022. So it feels vaguely […]
February 11, 2025 — Was the multi-million dollar spend by Hims & Hers on a Super Bowl ad the last gasp of a doomed business? Or was it a clever play for regulatory latitude that could keep them going? Conventional wisdom suggests that GLP-1 compounders should be nearing the end of their rope. But some political observers think they […]
December 30, 2024 — This year is rapidly winding down and already, our gaze is shifting toward expectations for the coming year. So before that shift is complete and we start making predictions for 2025, let’s check the scorecard for the expectations we had for 2024. A year ago, we put forward predictions of five hot topics for the […]
December 20, 2024 — Are we indeed reaching the end of the on-again, off-again supply shortage for GLP-1 obesity medicines? That seems to be what FDA signaled yesterday. The agency posted a brief statement, not only noting its determination that the tirzepatide shortage is “resolved,” but also saying the national GLP-1 supply has begun to stabilize. FDA is looking at […]
December 12, 2024 — These two companies have a history of surprising us and they’ve done it again – this time in a joint initiative. Lilly announced a bold move yesterday to distribute their lower priced vials of tirzepatide for obesity through the telehealth company known as Ro. A spokesperson for Lilly explained the arrangement by saying: “Ro is […]
December 4, 2024 — Why can’t they just go away? When compounded GLP-1 medicines started showing up two years ago, they seemed like a temporary distraction. In The New Yorker, Jia Tolentino described a dubious concoction of semaglutide she obtained from a compounding pharmacy for herself to mix and inject. “No thanks,” we wrote, hoping this sketchy business would […]
November 24, 2024 — FDA is in a quandary about compounding of the new obesity drugs, semaglutide and tirzepatide. The U.S. President-Elect has a nominee to lead FDA with a connection to this compounding kerfuffle. Marty Makary is a surgeon and professor at the Johns Hopkins School of Medicine. He is also Chief Medical Officer for the telehealth company […]
November 22, 2024 — FDA told a Federal judge yesterday that the agency isn’t yet sure whether there’s still a shortage of tirzepatide in the U.S. The agency needs more time to think about this. So for now, we have a stalemate on compounding of both semaglutide and tirzepatide. They are still on the FDA shortage list and compounders […]
October 17, 2024 — On again, off again. With impressive nimbleness, the U.S. Food and Drug Administration reversed course on tirzepatide compounding in large-scale pharmacy facilities. On October 2, they told those facilities to knock it off. Late last week, the agency told them to carry on – for now. FDA was responding to a lawsuit filed by compounding […]
October 13, 2024 — We are witnessing quite a number of battles unfolding and harming innocent people in diverse settings. They range from actual wars to political contests to the lucrative business of healthcare. A common thread in all of these situations is shamelessness in pursuing money, power, or both. That shamelessness is especially troubling when it pops up […]
