Drugs

Report Finds Troubling Drug Imports for Weight Loss

Partnership for Safe Medicines (PSM) has released a new report that found “suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity injectables (commonly known as weight loss drugs) are flooding into the U.S. from foreign sources despite U.S. laws forbidding them from coming through the border.” Despite FDA warnings against drug compounders’ use of foreign-sourced, unauthorized bulk drug ingredients (semaglutide and tirzepatide), “use of compounded versions of GLP-1 medications has surged, with telehealth companies and compounding pharmacies aggressively marketing them to consumers,” the report says.

PSM partnered with former FDA Office of Criminal Investigations director and federal prosecutor George Karavetsos to analyze publicly available import data against the agency’s database for registered drug manufacturers between 9/2023 and 1/2025 to better highlight the risks for the report. The report found that:

Import records show 239 shipments of semaglutide and tirzepatide arrived from foreign manufacturers that failed to register their facility.
FDA stopped just 44 of these shipments, allowing 195 illegal shipments into the U.S. market, where they were likely used in knockoff products sold to unsuspecting Americans.
60 shipments of unregistered semaglutide and tirzepatide originated from China or Hong Kong and 42 originated from India.
Many of these shipments were identified as ingredients for use in drug compounding. Others used even more troubling descriptions, such as “non-sterile liquids.” Semaglutide and tirzepatide are injectable products that must be sterile.

The report outlines several urgent actions FDA should take, including refusing entry to any drugs that appear to be misbranded, adulterated, or otherwise unapproved, and to add the rogue manufacturers identified in the report’s analysis to the Import Alert system to flag their future shipments. Additionally, it recommends that FDA and state boards of pharmacy should prioritize inspections of compounders that attempt to import GLP-1 active ingredients from unregistered facilities.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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

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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