Posts Tagged ‘FDA’

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 […]

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 […]

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 […]

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 […]

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 […]

Novo Nordisk and Lilly reported on their business results this week for the final quarter of 2024. These reports brought clarity on a number of points, but to us, one thing stands out. We are moving from euphoria and hype about limitless possibilities in obesity to the realities of market competition and incremental progress. Sales […]

Chasing the possibility of multi-billion dollar obesity medicines, pharmaceutical companies are jumping at the chance to spend billions in clinical research. But patient advocates find a reluctance from some of those same companies to take people with obesity into account in the drug labels for their products already on the market. Writing for In Vivo, […]

For persons with obesity and prediabetes, one of the best ways to prevent diabetes onset is quite clear. Treat the obesity to reduce the excess adiposity. The Diabetes Prevention Program established this with a study in the NEJM way back in 2002. A prescription of diet and exercise could cut the risk of diabetes in […]

FDA yesterday approved Ozempic (semaglutide) to prevent kidney failure and death in persons with type 2 diabetes and chronic kidney disease. This fits with one of the five trends for this year: the steady expansion of health benefits for advanced medicines used in obesity and diabetes. But note that this approval covers the use of […]

In the midst of lot of news about obesity this week came a pretty big announcement from FDA. The agency is proposing to require front-of-pack nutrition labels for most packaged foods in the U.S. FDA is optimistic. Food policy advocates are cheering. This will be a big opportunity to reduce obesity says FDA: The U.S. […]