Drugs

Cotton Urges FDA Probe Into Chinese APIs for GLP-1 Drugs

Sen. Tom Cotton (R-AR) is pressing FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients (APIs) have entered the U.S. supply chain and been used in compounded GLP-1 weight loss drugs. In a 2/13 letter to FDA commissioner Martin Makary, the Arkansas lawmaker cited national security and patient safety concerns, warning that foreign access to the U.S. pharmaceutical supply chain presents “significant health risks” to Americans. Cotton referenced recent reports indicating that between 9/2023 and 1/2025, FDA and U.S. Customs and Border Protection intercepted 195 illegal API shipments, roughly 60 of which originated from China or Hong Kong. He said the seized ingredients were likely intended for use in compounded weight loss medications.

Cotton estimated that as many as 1.5 million Americans could be using unregulated compounded GLP-1 products that may contain questionable foreign-sourced ingredients. The senator’s letter comes amid broader federal scrutiny of companies marketing compounded alternatives to approved GLP-1 therapies such as Ozempic and Wegovy. Earlier this month, HHS referred Hims & Hers Health to the Justice Department for potential violations of the Federal Food, Drug, and Cosmetic Act tied to its planned sale of a non-FDA-approved compounded weight loss drug. Makary has separately signaled that the agency will move to restrict bulk GLP-1 APIs intended for use in mass-marketed compounded products.

Cotton urged regulators to expand investigations to other entities distributing compounded GLP-1 drugs, arguing that stronger oversight is needed to prevent potentially unsafe ingredients from reaching U.S. patients.

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