Drugmaker Novo Nordisk is taking action to curb the massively popular compounded semaglutide industry, which provides copies of its blockbuster weight-loss drugs Ozempic and Wegovy to patients—often for much lower prices.
The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) lists, which would block compounding pharmacies from producing dupes of the drug. In a filing posted by the agency on Tuesday, lawyers for Novo Nordisk reason that semaglutide belongs on the these lists “due to the complexities associated with their formulations,” among other reasons.
“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide product,” says Novo Nordisk director of media relations Jamie Bennett.
FDA press officer 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 compounding industry—and for the likely millions of people currently taking compounded GLP-1 drugs.
Injectable GLP-1 drugs including semaglutide and tirzepatide have been in shortage since 2022 because of their huge popularity. In the US, when the FDA declares that a drug is in shortage, certain licensed pharmacies are permitted to make “compounded” versions of the medication, which are mixed in-house and are supposed to contain the same active ingredients as the original drug.
Telehealth providers have capitalized on the GLP-1 drug shortage, offering patients compounded versions via quick virtual appointments. The practice has created tension 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 a month without insurance, while compounded semaglutide is advertised for as low as $100 a month online.
Unlike generic medications, which are manufactured after drug patents expire, compounded medications are not subject to FDA approval before hitting the market. This means that the FDA cannot vouch for the safety, effectiveness, or quality of compounded drugs before they’re sold to patients. The FDA has received multiple reports of adverse side effects, including hospitalization, related to possible dosing errors associated with compounded semaglutide products.