Drugmaker Novo Nordisk is taking steps to curb the extremely popular compound semaglutide industrywhich provides patients with copies of its blockbuster weight-loss drugs Ozempic and Wegovy, often at much lower prices.
The Danish pharmaceutical company is lobbying the U.S. Food and Drug Administration to add semaglutide to the agency’s Demonstrable Compounding Difficulty (DDC) lists, which would prevent compounding pharmacies from producing fooled by the drug. In a file published by the agency on TuesdayNovo Nordisk’s lawyers believe that semaglutide belongs on these lists “because of the complexities associated with their formulations,” among other reasons.
“These medications are inherently complex to prepare safely, and the risks they pose to patient safety far outweigh their benefits. Novo Nordisk’s goal with this appointment is to ensure that patients receive only a safe and effective FDA-approved semaglutide product,” said Jamie Bennett, Novo Nordisk Director of Media Relations.
FDA press secretary Amanda Hils told WIRED via email that the agency is “reviewing the petition and will respond directly to the petitioner.”
If granted, the designation would have seismic implications for the compounded drug industry – and for the likely millions of people currently taking GLP-1 compounded drugs.
Injectable GLP-1 drugs, including semaglutide and tirzepatide, have been in shortage since 2022 due to their huge popularity. In the United States, when the FDA declares a drug to be in shortage, some licensed pharmacies are allowed to manufacture “compounded” versions of the drug, which are mixed in-house and are believed to contain the same active ingredients as the original drug. origin.
Telehealth providers have capitalized on the GLP-1 drug shortage, offering patients compounded versions via quick virtual meetings. This practice has created tensions with the pharmaceutical companies that make the brand-name drugs, since the compounded versions are sold at much lower prices. Ozempic and Wegovy can cost around $1,000 per month without insurance, while compounded semaglutide is advertised for as little as $100 per month online.
Unlike generic drugs, which are manufactured after pharmaceutical patents expire, compounded drugs are not subject to FDA approval before being released to the market. This means that the FDA cannot guarantee the safety, effectiveness, or quality of compounded drugs before they are sold to patients. The FDA received multiple reports of adverse side effectsincluding hospitalization, related to possible dosing errors associated with semaglutide compound products.
