Eli Lilly and Novo Nordisk have recently filed lawsuits against companies selling compounded versions of their drugs, alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. In June, Eli Lilly filed six lawsuits, following 10 lawsuits it filed last fall. One of the lawsuits was against a company selling compounded GLP-1 online, alleging that marketing compounded drugs as having the same active ingredients as its own products is “not just deceptive, but dangerous.”
“Telehealth providers and compounding pharmacies offering or selling unapproved compounded products claiming to contain ‘semaglutide’ are sourcing ingredients from companies other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. “The FDA WarnedUnapproved combined ‘semaglutide’ medicines do not have the same guaranteed safety, quality or effectiveness as Novo Nordisk’s FDA-approved semaglutide medicine, and patients should not use combination medicines when an approved medicine is available.”
“The safety implications are huge,” Ryder said. In 2012, a compounding pharmacy was hit by a fungal infection. Meningitis outbreak At least 64 people died in the incident, which was one of the worst pharmaceutical contamination incidents in the U.S. The supervising pharmacist who oversaw the drug’s production was sentenced to prison and led to increased oversight and licensing requirements for compounding pharmacies.
Some of the larger compounding pharmacies that make GLP-1 drugs have run into problems because of their practices. One popular supplier, Hallandale Pharmacy (two of my four vials came in their sleek blue packaging), Trouble with regulators Past violations have included concerns about record-keeping and facility conditions. I received a warning letter The last one from the FDA was terminated in May 2022, meaning the agency determined it had addressed the outstanding issues. (Halandale declined a request for comment.)
The FDA has also found problems with pharmaceutical companies. In 2023, FDA inspectors found Bacterial contamination was found at Novo Nordisk’s production plant in North Carolina. “Management responded quickly, and the plant received FDA approval for full market production in August 2023,” Novo Nordisk’s Bennett said.
Pharmacy advocates say that although the drugs aren’t FDA-approved, they’re still subject to strict quality controls due to rule changes since 2012. Carroll, for example, said Hims did its “due diligence” in selecting pharmacies and is happy with the quality of the drugs. “We’ve had very good feedback from customers,” he said. “We’ve had no unexpected side effects.” Carroll said Hims hasn’t had to report any side effects to the FDA.
What’s next?
As researchers continue to discover new potential uses for GLP-1 drugs, and public interest and demand remain high, these drugs may remain on the FDA’s official shortage list for the coming months or years. Once the shortage is resolved, certain types of compounding pharmacies (called 503a) will be required to immediately stop production, while 503b pharmacies, which typically produce on a larger scale, will be able to continue. 60 DaysResolving the shortage would require a major pivot in this burgeoning small-scale industry. None of the telemedicine companies that sent dispensed semaglutide to WIRED said what would happen during the intake process in this scenario.
Many people taking compounded drugs might be surprised to be told that within a few months they will have to switch to a brand-name drug and pay a much higher price.
But even if the shortage is officially over, at least some telehealth companies don’t plan to pivot from dispensing. “We see a growing demand for medications, and that could actually lengthen the shortage list,” says Pat Carroll of Hims. “We’re confident that even if we come off the shortage list, we’ll have a path to supply dispensed medications.”
Even skeptics don’t see this boom going away anytime soon. Demand is so high that Ryder believes pharmaceutical companies will have to ramp up production to supply “basically 40% of the U.S. population” before the shortage is resolved. Until then, Ryder sees this telemedicine boom continuing unabated.
For now, the vial of compounded semaglutide that WIRED ordered is languishing in the back of the fridge.
