Novo Nordisk Asks FDA to Ban Compounded Copycat Weight-Loss Drugs

The logo of Danish pharmaceutical company Novo Nordisk is pictured at their headquarters in Bagsvaerd outside of Copenhagen, Denmark, on Feb. 1, 2017. Liselotte Sabroe/Ritzau Scanpix/AFP via Getty Images

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.

In the Oct. 22 request, Novo Nordisk asked the FDA to include semaglutide on its Demonstrable Difficulties for Compounding (DDC) lists. Semaglutide is the active ingredient in the company’s weight loss drug Wegovy and diabetes treatment Ozempic. There has been a shortage of both drugs in the United States for most of this year.

Compounding involves mixing or altering ingredients to create a medication tailored for a specific patient. Compounded drugs are often sold at vastly lower prices than the branded versions. When a brand-name medication is in shortage, compounding pharmacies can also prepare copies of the drug if they meet FDA requirements.

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.

In February, the FDA issued a warning about the risks of using compounded versions of GLP-1s such as semaglutide and tirzepatide. In July, the agency said it had received reports of patients overdosing on compounded semaglutide injectable products due to users self-administering incorrect dosages.

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.

A Novo Nordisk spokesperson told The Epoch Times that the company’s top priority is patient safety.

“The nomination of semaglutide to the FDA’s Demonstrable Difficulties for Compounding (DDC) Lists is a significant step towards keeping people safe from unapproved and potentially harmful versions of knock-off semaglutide drugs,” the spokesperson said.

According to the spokesperson, the DDC nomination already provides numerous examples of the risks posed by compounded versions of semaglutide, including unknown impurities, peptide-related impurities, incorrect strengths, and even instances where no semaglutide was present in the product at all.

“The DDC Lists were created to safeguard public health by preventing the compounding of complex products that could pose significant safety risks,” the spokesperson said. “Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them.”

The spokesperson said organizations, including The Obesity Society, Obesity Medicine Association, and Obesity Action Coalition, along with twelve state regulators, have issued warnings about the safety risks of compounded semaglutide products.