Drugs

Court Confirms FDA Drug Shortage Ruling was Valid

A northern Texas judge has ruled in FDA’s favor in a case challenging its decision last year to remove Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro from its drug shortage listing, a move that ultimately made it illegal for compounding pharmacies to produce large quantities of the drug copies to meet increased market demand.

U.S. district judge Mark Pittman’s 5/7 decision, which was filed under seal, stemmed from an October lawsuit by Outsourcing Facilities Association seeking to reverse the “resolved” drug shortage listing. The group, which has filed an appeal, argued that FDA had wrongly and exclusively relied on statements by Lilly to determine whether there was a continuing shortage, and that patients were still having trouble obtaining drug supplies.

Last month, the judge also rejected a similar argument by compounding pharmacies to keep making copies of Novo Nordisk’s diabetes and weight-loss drugs Ozempic and Wegovy while a legal challenge over drug shortages is litigated.

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