Novo Nordisk has asked the Food and Drug Administration (FDA) to block compounding pharmacies from selling proprietary versions of its popular weight loss drug Wigoby and diabetes drug Ozempic, saying the drugs are too complex for pharmacies to manufacture safely. We are asking them to stop their production.
Compounded anti-obesity drugs are sold at significantly lower prices than branded products and can help patients access the medicines they need when they are in short supply.
Ozempic and Wegovy cost about $1,000 per month without discounts, and many insurance plans do not broadly cover weight-loss drugs. Semaglutide, the active ingredient in both, has been in short supply for more than two years.
But Novo Nordisk has asked the FDA to add semaglutide to the list of “complex drugs” that compounders are not allowed to manufacture regardless of shortages, citing potential safety risks.
“These drugs are inherently complex to formulate safely, and the risks to patient safety far outweigh the benefits,” the drug companies said in a statement.
The FDA has not yet made a final decision.
Novo Nordisk said the request was “an important step to protect people from unapproved and potentially harmful counterfeit semaglutide drugs,” and the company said it was “an important step to protect the public from unapproved and potentially harmful counterfeit semaglutide drugs,” and that the company is “giving patients access to FDA-approved, safe and effective semaglutide drugs.” “We want to make sure that only semaglutide can be administered.” product. ”
The report cites several risks with combination versions of semaglutide, including unknown impurities, inaccurate dose strengths, and when the combination product does not contain semaglutide at all.
The Danish company's request comes as it works to expand supply in the United States in response to surging demand. It also means increased efforts to crack down on clinics, pharmacies, and other manufacturers selling what they claim are unsafe counterfeits of semaglutide.
Combined forms of semaglutide have not been approved by the FDA, which said earlier this month that they may pose a risk to patients.
The Pharmacy Compounding Alliance was quick to point out that adverse events reported by patients taking the combined version of the drug were “remarkably similar to those reported by patients taking the FDA-approved version.” I did.
Scott Brunner, the group's chief executive, said in a statement that if Novo Nordisk was so concerned about patient safety, why would it put semaglutide on the FDA's list of complex medicines due to a shortage? I asked him if it took him two and a half years to recommend him to the list.
“To me, this looks more like desperation and an attempt to protect Novo's revenue stream than a serious scientific discussion,” Bruner said.
“Novo's ridiculous claim to the contrary is that compounding pharmacies are dispensing compounded versions of these life-enhancing drugs to hundreds of thousands of patients. Novo doesn't like that. I understand, but the answer is not to limit patient access… [Novo] “It's about fixing the supply chain,” he added.
