The maker of weight loss drug Wegovy and diabetes treatment Ozempic is calling on the Food and Drug Administration to prevent compounding pharmacies from manufacturing their own version of the popular drugs. The medications contain semaglutide, which Denmark-based drug maker Novo Nordisk argues is too complex to be made safely.
Compounded formulas go for much less than the branded versions, which cost about $1,000 a month. And insurance plans don't widely cover the drugs if used for weight loss. Additionally, there have been shortages of semaglutide for more than two years now. Compounded versions make the drugs cheaper and more accessible to more patients.
Demand for semaglutide drugs have skyrocketed in recent years.
Novo Nordisk is asking the FDA to add semaglutide to its list "complex medicines," which bars compounders from making a drug — even if there's a shortage — arguing it poses a safety risk. Novo Nordisk said in a statement that the safety risks "far outweigh any benefits." The drug maker added that the company wants to "ensure that patients receive only FDA-approved, safe, and effective semaglutide products."
The company went on to list a series of risks that can occur with compounded versions of semaglutide, including incorrect dosing, unknown impurities, and even situations where the product didn't contain the drug at all.
Meanwhile, the Alliance for Pharmacy Compounding noted that adverse effects patients reported with the compounded versions of semaglutide "are remarkably similar to those reported by patients taking the FDA-approved version." The group's CEO said in a statement, "To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument."
The FDA has not weighed in yet.