Drugmaker Novo Nordisk is moving to clamp down on the wildly popular combination semaglutide industry, which is supplying patients with copies of its blockbuster weight-loss drugs Ozempic and Wegovy – often at much lower prices.
A Danish pharmaceutical company is lobbying the U.S. Food and Drug Administration to add semaglutide to the agency’s difficult-to-mix (DDC) lists, which would prevent compounding pharmacies from making drug substitutes. In the request sent by the agency on TuesdayNovo Nordisk lawyers believe that semaglutide is on these lists, among other things, “due to the complexities associated with their formulations.”
“Combining these drugs safely is inherently complex, and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s goal with this appointment is to ensure that patients receive only an FDA-approved, safe and effective semaglutide product,” says Jamie Bennett, director of media relations at Novo Nordisk.
FDA spokeswoman Amanda Hils told WIRED via email that the agency “is reviewing the petition and will respond directly to the petitioner.”
If granted, this designation would have seismic consequences for the compounding industry and likely for the millions of people currently taking GLP-1 compounded medications.
Injectable GLP-1 drugs, including semaglutide and tirzepatide, are in compact supply as of 2022 due to their overwhelming popularity. In the United States, when the FDA determines that a particular drug is in compact supply, some licensed pharmacies may manufacture “compounded” versions of the drug, which are mixed on site and should contain the same energetic ingredients as the original drug.
Telehealth providers have taken advantage of the shortage of GLP-1 drugs by offering convoluted versions to patients through quick virtual visits. This practice has caused tensions with drug companies that produce brand-name drugs because combination versions are sold at much lower prices. Ozempic and Wegovy can cost about $1,000 a month without insurance, while the combined semaglutide is advertised online for as little as $100 a month.
Unlike generic drugs, which are produced after drug patents expire, combination drugs are not subject to premarket approval by the FDA. This means that the FDA cannot vouch for the safety, effectiveness, or quality of combination drugs before they are sold to patients. FDA received numerous reports of undesirable side effectsincluding hospitalization related to possible dosing errors associated with semaglutide combination products.