May 22, 2025 — The game is over. Today is the day legal semaglutide compounding at scale ends by decree from the FDA. Compounding pharmacies have known this day was coming since February when the agency determined that the shortage of semaglutide from Novo Nordisk was over. Well-informed patients who have depended upon compounding for affordable access to a […]
May 3, 2025 — Rather quietly this week, Eli Lilly and Company announced that it had withdrawn an application to FDA for an indication to use tirzepatide (Zepbound) in treating heart failure – specifically for HFpEF. This news came up in a briefing for investors, with Lilly’s Chief Scientific Officer, Dan Skovronsky, saying: “Following discussions with the FDA, we’ve […]
April 22, 2025 — Change is hard and people resist it. FDA is coming to terms with the idea of radical transparency and certainly drug labels are a good place to start. When we talk about drug labels for prescription drugs, it means the lengthy “prescribing information” that FDA reviews and approves. Its purpose is to tell doctors, pharmacists, […]
April 4, 2025 — On Tuesday, as part of mass firings, the powers that be at FDA lined people up to fire them. Security guards delivered the news. Clumsily. Now, just two days later, it seems they want a do over. The Washington Post reports the agency is trying to bring back a big chunk of people they fired: […]
April 2, 2025 — Yesterday was a profoundly sad day for people who care about American greatness in health. With a measure of gratuitous cruelty, the U.S. Department of Health and Human Services slashed 10,000 jobs, wiping out a stunning breadth of health expertise at FDA, CDC, and NIH. Robert Califf, an international expert in clinical research and cardiovascular […]
March 26, 2025 — In the U.S., we are at a critical point for the sourcing obesity medicines. March 19 was the last day that FDA would tolerate large scale compounding of tirzepatide on account of the now resolved shortage of that drug. The same milestone for semaglutide is coming up on May 22. Some people are not happy. […]
March 16, 2025 — A regulatory detail deep within the thicket of FDA rules is getting sharp attention. This week, HHS Secretary RFK Jr. asked FDA to find a way to restrict something called GRAS. That stands for generally recognized as safe. Right now, a food company can “self certify” that a chemical food additive is GRAS. Then they […]
March 5, 2025 — FDA seems to be moving toward giving more and more attention to accurate drug labeling for people with obesity. Yesterday, Medscape published a deep exploration of this issue. The timing coincided nicely with Obesity Care Week and World Obesity Day, Responding to Medscape Medical News, FDA made reference to a workshop they sponsored on the […]
February 25, 2025 — A concern is surfacing as obesity treatments become more and more effective. The measurement for success has long been percent weight loss. But thoughtful people have always known that the right target for obesity care was actually improved health. It was okay to focus on weight as a measure of effectiveness when the the effect […]
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 […]
