Drugs

AGs Seek FDA Actions on Counterfeit GLP-1 Drugs

A bipartisan coalition of 37 state Attorneys General (AGs) is urging FDA to take enforcement actions against online sellers of “harmful counterfeit versions of popular weight-loss and diabetes drugs like Ozempic, Wegovy, Mounjaro, and Zepbound.” In a 2/19 letter to the agency, the AGs warn that counterfeit GLP-1 drugs containing contaminants or unregulated active ingredients have entered the U.S. from countries such as China, Turkey, and India. “Online retailers, often using social media, are illegally selling the active ingredients in GLP-1 drugs — which may contain harmful substances — to consumers without a prescription,” they contend.

Additionally, the AGs call on FDA to also “ramp up enforcement” against any compounding pharmacies that may be illegally participating in this market. “Unfortunately, while many compounding pharmacies adhere admirably to the best practices of their profession, some have cut corners in pursuit of a quick profit,” the letter says. “The manufacturer of Mounjaro and Zepbound [Eli Lilly] has reportedly discovered compounded versions of the medications with high impurity levels or that were contaminated with bacteria… their profession, some have cut corners in pursuit of a quick profit… The FDA must work in partnership with state pharmacy boards to ensure compounded GLP-1 drugs are produced in a safe, sanitary way."

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

Read more

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