Pharmaceutical company Novo Nordisk has taken action to rein in the hugely popular combination semaglutide industry, which is offering copies of its blockbuster weight loss drugs Ozempic and Wigovy to patients, often at much lower prices. are.
A Danish pharmaceutical company is lobbying the U.S. Food and Drug Administration to add semaglutide to the agency’s Difficulty Compounding List (DDC). This prevents dispensing pharmacies from manufacturing counterfeit products of the drug. In a filing posted by the agency on Tuesday, Novo Nordisk’s lawyers reasoned that semaglutide was included on these lists, among other things, “due to the complexities associated with the formulation.” .
“These drugs are inherently complex to synthesize safely, and the risks to patient safety far outweigh the benefits. to ensure that they only receive safe and effective semaglutide products,” said Jamie Bennett, director of media relations at Novo Nordisk.
FDA spokeswoman Amanda Hills told WIRED in an email that the agency is “reviewing the petition and intends to respond directly to the petitioner.”
If approved, this designation would have significant implications for the compounding industry and likely for the millions of people currently taking compounded GLP-1 drugs.
Injectable GLP-1 drugs such as semaglutide and tirzepatide have been in short supply since 2022 due to their popularity. In the United States, when the FDA declares a drug to be in short supply, certain licensed pharmacies sell “combined” versions that are mixed in-house and are assumed to contain the same active ingredients as the original drug. are permitted to manufacture pharmaceutical products.
Telemedicine providers are taking advantage of GLP-1 drug shortages and offering compounded versions to patients through quick virtual appointments. The practice has caused tensions with drug companies that make branded drugs, as compounded versions are sold at much lower prices. Ozempic and Wegovy cost about $1,000 per month without insurance, while combination semaglutide is advertised online for as low as $100 per month.
Unlike generic drugs, which are manufactured after a drug’s patent has expired, compounded drugs do not have to be approved by the FDA before they can be placed on the market. This means that the FDA cannot guarantee the safety, effectiveness, or quality of compounded drugs before they are sold to patients. FDA has received multiple reports of adverse side effects, including hospitalizations, related to possible dosing errors associated with semaglutide combination products.
