WHO Adds GLP-1 Diabetes Drugs to Essential Medicines List

The World Health Organization (WHO) has added several GLP-1 receptor agonists, including semaglutide, dulaglutide, liraglutide, and tirzepatide, to its Model Lists of Essential Medicines, recognizing their significant benefits for treating type 2 diabetes and obesity. WHO highlighted the high cost of these drugs, which could limit accessibility, and called for their integration into global primary care systems and the development of affordable generic alternatives to increase availability worldwide. In response to the rising demand and safety concerns over compounded versions of GLP-1 drugs, the U.S. Food and Drug Administration (FDA) introduced a “green list” import alert to ensure that only GLP-1 active pharmaceutical ingredients (APIs) from inspected and compliant foreign manufacturers enter the U.S. market. The FDA emphasized that this measure aims to protect consumers from dangerous counterfeit or substandard compounded medications, a concern underscored by recent issues with counterfeit drugs flooding the U.S. from China. Pharmaceutical companies like Novo Nordisk and Eli Lilly have opposed compounding of their GLP-1 drugs citing safety and economic concerns, reinforcing the FDA’s efforts to regulate these ingredients. Overall, these developments reflect a global push to both broaden access to effective GLP-1 therapies and safeguard drug quality amid increased demand and pricing challenges.