Pharmaceutical giant Novo Nordisk (NYSE:NVO) is lobbying the US Food and Drug Administration (FDA) to restrict compounded versions of its popular weight-loss drug Ozempic.
Unregulated compound
The stated aim is to halt the production of cheaper, non-branded, unregulated alternatives, which – along with competing with the lucrative Novo asset – could prove dangerous because they are not FDA approved.
The Danish drugmaker has formally requested that semaglutide – the active ingredient in Ozempic and Wegovy – be added to the FDA's Demonstrable Difficulties for Compounding (DDC) lists.
This designation would prevent compounding pharmacies from creating and distributing versions of semaglutide, which have become increasingly popular due to lower prices and high demand, especially in light of supply shortages.
Since the injectable GLP-1 drugs, semaglutide and tirzepatide, gained traction in 2022, compounding pharmacies and telehealth providers have supplied compounded copies to meet demand.
Cheap alternative
These alternatives, which can be priced as low as $100 per month, have created a market that Novo Nordisk (NYSE:NVO) argues is fraught with safety risks, including potential dosing errors.
Unlike generic drugs, compounded medications do not undergo FDA approval before reaching patients, which raises concerns about their quality and safety.
Novo Nordisk claims that semaglutide’s complexity makes safe compounding difficult and asserts that the risks outweigh the benefits, whereas compounded semaglutide has been linked to adverse effects, including hospitalisations, per FDA reports.
Novo Nordisk has already taken legal action, filing dozens of federal lawsuits against providers of compounded versions, including telehealth clinics and medspas.
Ongoing battle
This push from Novo follows a similar recent effort by Eli Lilly, whose GLP-1 drug tirzepatide briefly faced a declared shortage before the FDA retracted its listing.
This ongoing battle between pharmaceutical companies and the compounding industry is symptomatic of broader tensions over unregulated compounded drugs.
The FDA is reviewing Novo’s request, with the outcome of its decision presenting implications for patients and providers alike.