Posts Tagged ‘FDA’

Five years ago, Danone asked FDA if it would be OK to say eating yogurt might prevent type 2 diabetes. Or to be precise, “eating yogurt regularly may reduce the risk of type 2 diabetes.” Friday, FDA told Danone, yep, we’re cool with that. Or, in the language of the agency: “FDA concludes that the […]

It seems obvious. If food is medicine, shouldn’t we be confident that chocolate is medicine? Certainly, Uma Naidoo is happy to sell you on this idea. She is a nutritional psychiatrist and author of “This Is Your Brain on Food: An Indispensable Guide to the Surprising Foods That Fight Depression, Anxiety, PTSD, OCD, ADHD and […]

The calls are growing louder and more frequent to include people living with obesity in clinical trials and drug labels. Of course trials and labels for drugs that treat obesity include these patients. But the huge problem is that for everything else, more often than not, drug studies and labels exclude them. Now, the American […]

Unfortunately, we are facing the new year with a great demand for advanced new obesity medicines and an inadequate supply. On the FDA drug shortages website, all strengths of the Wegovy brand, except 2.4 mg, have limited availability. Both Wegovy and Ozempic are “currently in shortage.” This opens the door for compounded semaglutide and a […]

FDA tells us we have a problem – actually two of them, and they’re connected to a third. First, counterfeit versions of the Ozempic brand of semaglutide injections are finding their way into pharmacies. These fakes present an inherent risk of problems with safety and effectiveness. Second, compounded versions of semaglutide are selling in some […]

It is time to translate words into action and fix the blind spot in drug trials and labeling for people with obesity. Every major obesity group in the U.S. issued this united call to action on Tuesday. This includes the ASMBS, Obesity Action Coalition, Obesity Medicine, Obesity Society, and STOP Obesity Alliance. It comes as […]

FDA has a bone to pick with Otsuka, the company that sells Rexulti (brexpiprazole). The agency is taking issue with false advertising by the company for this drug used in schizophrenia and severe depression. To us, this problem of inflated efficacy claims is especially noteworthy because, for people with obesity who may need this drug, […]

At a time when nearly half of the U.S. population is living with obesity, this should be an easy question to answer. Obesity clearly causes some forms of cancer and as the prevalence of obesity is rising, patterns of cancer prevalence are shifting, too. So, yes, we should be able to say with great confidence […]

In an era of tremendous change for obesity care, this is certainly a huge milestone. FDA approved tirzepatide for obesity treatment yesterday and put Lilly in the position to offer serious competition to Novo Nordisk. But the question that matters most to us is simple. How will this competition help people seeking to cope with […]

Public health experts have long been accounting for it. People are living in larger bodies. Better than 40% of U.S. adults have a body weight in the range of obesity. But new reporting from JoNel Aleccia for the Associated Press tells us that pharma and the FDA are not yet accounting for this fact. It’s […]