Drugmaker Novo Nordisk is taking steps to curb the hugely popular compounded semaglutide industry, which provides copies of its hit weight-loss drugs Ozempic and Wegovy to patients, often at much lower prices.
The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s lists of demonstrable difficulties in compounding (DDC), which would prevent compounding pharmacies from producing copies of the medication. in a presentation published by the agency on TuesdayNovo Nordisk’s lawyers reason that semaglutide belongs on these lists “due to the complexities associated with its formulations,” among other reasons.
“These medications are inherently complex to combine safely and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s goal with this nomination is to ensure that patients receive only a safe, effective, FDA-approved semaglutide product,” says Novo Nordisk Director of Media Relations Jamie Bennett.
FDA press officer Amanda Hils told WIRED by 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 compounding industry and for the likely millions of people currently taking GLP-1 compounded medications.
GLP-1 injectable drugs, including semaglutide and tirzepatide, have been in short supply since 2022 due to their enormous popularity. In the United States, when the FDA declares that there is a shortage of a drug, certain licensed pharmacies are allowed to manufacture “compounded” versions of the drug, which are mixed in-house and are supposed to contain the same active ingredients as the original drug.
Telehealth providers have taken advantage of the GLP-1 drug shortage and are offering patients compounded versions through quick virtual appointments. The practice has created tension with pharmaceutical companies that make brand-name drugs, as compounded versions are sold at much lower prices. Ozempic and Wegovy can cost around $1,000 a month without insurance, while compounded semaglutide is advertised online for as little as $100 a month.
Unlike generic drugs, which are manufactured after the drug’s patents expire, compounded drugs are not subject to FDA approval before they go on 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 has received multiple reports of adverse side effectsincluding hospitalization, related to potential dosing errors associated with semaglutide compound products.