The U.S. Food and Drug Administration on Friday established a "green list" import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.
Certain GLP-1 drugs, including Novo Nordisk A/S’ (NYSE:NVO) semaglutide and Eli Lilly and Co.’s (NYSE:LLY) tirzepatide, are FDA-approved for specific uses such as treating type 2 diabetes and, in certain cases, chronic weight management.
However, the agency is aware that some patients are turning to compounded versions of these drugs, which the FDA does not approve. To protect patients who use these compounded drugs, the green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to comply with the FDA standards.
APIs from other sources are subject to detention without physical examination.
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Most recently, China-based drugmakers that once fueled a surge of copycat weight-loss treatments in the U.S. are now pivoting to generics of Novo Nordisk‘s Wegovy and Eli Lilly‘s Zepbound as regulators tighten rules on compounded medicines.
After unprecedented demand strained branded supplies, at least eight Chinese firms—including Jiangsu Sinopep-Allsino and Hybio Pharmaceutical—supplied raw ingredients that helped produce more than a billion makeshift doses in 2024, according to FDA shipping data cited by Reuters.
In July, in a letter to the U.S. Food and Drug Administration (FDA), over 80 bipartisan members asked the agency to stop counterfeit and copycat versions of GLP-1 drugs from flooding the market.
The group urged the FDA to issue warning letters, pursue civil enforcement, and monitor non-compliant online retailers and compounding pharmacies selling unapproved weight-loss drugs.
They also called on the agency to coordinate with Customs and Border Protection (CBP) to issue an import alert and crack down on Chinese entities shipping unsafe GLP-1 medications into the U.S. Citing the urgency of the issue, lawmakers requested an update on FDA enforcement efforts by July 30.
Concurrently on Friday, the World Health Organization (WHO) has released updated editions of its Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), adding new treatments for various types of cancer and for diabetes with associated comorbidities such as obesity.
Medicines for cystic fibrosis, psoriasis, haemophilia, and blood-related disorders are among the other additions.
The organization added GLP-1 receptor agonists – semaglutide, dulaglutide, and liraglutide – and the GLP-1/glucose-dependent insulinotropic polypeptide (GIP) dual receptor agonist (tirzepatide) to the list.
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