Danish pharma giant Novo Nordisk has asked the Food and Drug Administration (FDA) to stop compounding pharmacies from manufacturing versions of its weight-loss and diabetes drugs, claiming the main compound is too complex to replicate safely.
Novo Nordisk says compounded versions of semaglutide have risks, such as unknown impurities and incorrect dosage strengths.
“Semaglutide products belong on these lists due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing,” Novo wrote in its request to the FDA.
Inclusion on the DDC list means compounders are not allowed to make the drug, even during shortages, because they have been flagged as potentially posing a safety risk to consumers.
Novo Nordisk asked the FDA to convene an advisory committee to consider its request to add semaglutide products to the DDC list. A decision has yet to be made.
In the last year, Novo Nordisk has filed lawsuits against clinics, compounding pharmacies, and other manufacturers for making copycat versions of its popular drugs.
The Alliance for Pharmacy Compounding’s CEO Scott Brunner questioned Novo Nordisk’s move in an Oct. 23 social media post and asked why it took two and a half years to nominate semaglutide for the FDA’s complex medication lists.
Brunner said that adverse events reported by patients taking compounded versions of the drug “are remarkably similar to those reported by patients taking the FDA-approved version.”
He said he doesn’t think Novo’s action is based on a “serious scientific argument” but rather an attempt to crack down on the growing number of patients using the compounded drugs.
The Epoch Times reached out to Novo Nordisk for comment but did not receive a response by publication time.