Novo Nordisk, the pharmaceutical company behind the massively popular weight loss drugs Ozempic and Wegovy, is urging the FDA to block compounding pharmacies from making their own versions of semaglutide. The drugmaker is asking the FDA to add semaglutide to its Demonstrable Difficulties for Compounding (DDC) list, which would ban compounders from producing alternate versions of the drug.
According to Novo Nordisk, the compounded versions of semaglutide circulating in the market have “different impurity profiles” and don’t maintain the same chemical stability as the FDA-approved drug. This could lead to serious safety issues, and the company even pointed to cases where compounded semaglutide has triggered calls to poison control centers. Novo also raised concerns about the lack of clinical testing on these compounded versions, suggesting they could pose risks without any proven benefits.
“We haven’t found any actual or potential benefits that would outweigh the risks presented by compounded semaglutide,” Novo wrote in its FDA filing. In addition to getting semaglutide on the DDC list, the company is also asking the FDA to bring in its advisory committees to dive deeper into the safety concerns.
The Semaglutide Compounding Debate
While Novo Nordisk’s concerns center around patient safety, the broader issue is more complicated. Compounded versions of semaglutide became popular in part due to shortages of Ozempic and Wegovy, which have left patients searching for alternatives to keep their treatment on track. Compounded versions have offered a workaround, often at a lower price, though without the same stringent FDA oversight.
Now, Novo Nordisk’s push to limit compounding could leave many patients in a tough spot. If the FDA adds semaglutide to the DDC list, compounding pharmacies would no longer be able to offer their version, regardless of supply constraints.
And this comes on the heels of another significant decision: Eli Lilly’s tirzepatide—another popular GLP-1 drug for weight loss—was just removed from the FDA’s shortage list. As a result, patients who had been relying on compounded versions of that medication will now face much higher prices from pharmaceutical companies, especially if their insurance doesn’t cover the cost.
Patients Caught Between Safety and Costs
For many patients, the removal of compounded alternatives could mean skyrocketing costs. With drugs like semaglutide and tirzepatide priced at several hundred dollars per month, the burden falls heavily on those whose insurance doesn’t cover these treatments.
This latest development may feel like a blow to patients who have been benefiting from compounded versions during the shortages—especially with Eli Lilly’s recent FDA win. While safety concerns are valid, patients are understandably frustrated by what feels like limited options. Many will now have to navigate the high prices set by pharmaceutical companies, or worse, stop treatment altogether if they can’t afford it.
