The US Food and Drug Administration (FDA) has determined that semaglutide, an active ingredient in diabetes and weight-loss medications Ozempic and Wegovy, is no longer in shortage. This decision will have implications for patients taking cheaper, compounded versions of the drug.
Semaglutide was on the FDA’s shortage list since March 2022 due to high demand and supply issues. The shortage led to a lucrative industry of telehealth companies, medical spas, and pharmacies selling “compounded” copies of the medications at a steep discount.
The FDA has given “503A” compounders until April 22 to cease producing semaglutide, while larger “503B” compounding facilities have until May 22. However, there is reason to believe that players in this industry will push back on this announcement.
Drug compounding is a well-established practice, and pharmacists are permitted to make copies of medications when there’s a drug shortage or when patients need specific versions made. The GLP-1 boom has created an opportunity for compounders, but Novo Nordisk has taken action against the industry.
Novo Nordisk has filed over 50 lawsuits against compounders, telehealth clinics, and medspas, alleging trademark infringement and unfair competition. The FDA has set deadlines for compounders to stop producing semaglutide products, but it is not enforcing the deadlines as a lawsuit against the agency is ongoing.
Robert MacArthur, director of pharmacy at the Rockefeller University Hospital, says that once a drug comes off the FDA shortage list, outsourcing pharmacies should not compound it. However, smaller, traditional compounding pharmacies may continue to make drugs for home use if there’s a compelling reason, such as adjusting the dose or tailoring the medication.
Telehealth outfits have signaled their intention to continue offering their products, citing their right to provide personalized treatments allowed by law.
Source: https://www.wired.com/story/end-of-semaglutide-shortage-glp1-ozempic-wegovy