Drugs

Study Finds Compounded GLP-1 Market Remains Strong Despite FDA Crackdown

A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of enforcement against copies of commercially available products following the end of semaglutide and tirzepatide shortages.

Researchers conducted a "secret shopper" survey of 75 weight-loss clinics and medical spas in Oklahoma and West Virginia and found that more than half (56%) offered compounded GLP-1 products mixed with B vitamins, while about 9% sold oral formulations. The study also identified 23 compounding pharmacies supplying the products, including four that lacked licenses for sterile compounding and four that had been subject to FDA warning letters or state disciplinary actions since 2023.

The authors concluded that, although the FDA has resumed enforcement against unauthorized copies of GLP-1 drugs, compounders continue to market products with added ingredients that may fall outside those restrictions. They said the findings raise ongoing clinical and regulatory concerns because some suppliers lacked appropriate sterile compounding credentials or had histories of regulatory violations.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome