Eli Lilly and Novo Nordisk have recently taken legal action against companies that sell compounded versions of drugs, often alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. This June, Eli Lilly filed six lawsuits, following ten other lawsuits the drug company filed last fall. In one, filed against a company that sells compounded GLP-1 online, it alleged that passing off compounded drugs as having identical active ingredients as its products was “not only misleading, but dangerous.”
“Telehealth providers and pharmacies offering pre-prepared medications that claim to offer or sell unapproved pre-prepared products that claim to contain ‘semaglutide’ are sourcing their ingredients from entities other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. “As the FDA has warned“Unapproved compounded semaglutide medicines do not have the same safety, quality and efficacy assurances as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use a compounded medicine if an approved medicine is available.”
“There are huge safety implications,” Ryder says. In 2012, a pharmacy that made chemical preparations caused a fungal meningitis outbreak that killed at least 64 people, one of the worst pharmaceutical drug contamination disasters in the United States. The supervising pharmacist who oversaw the manufacture of this drug was sentenced to prison, and the event led to a tightening of oversight and licensing requirements for chemical preparation manufacturers.
Some major pharmacies that make GLP-1 drugs have run into trouble for their practices. Hallandale Pharmacy, a popular supplier (two of my four vials came in their fancy blue packaging) has run into trouble. Problems with regulators for past violations, which included concerns about record keeping and facility conditions. I received warning letters from the FDA, although the last one was closed in May 2022, meaning the FDA deemed it had addressed the outstanding issues. (Hallandale declined requests for comment.)
However, the FDA has also detected problems with pharmaceutical companies. In 2023, FDA inspectors will found Bacterial contamination at a Novo Nordisk production facility in North Carolina. “Management addressed the issue immediately and the plant received FDA approval for full market production in August 2023,” says Novo Nordisk’s Bennett.
Advocates for compounding pharmaceuticals say that although the drugs are not FDA-approved, they are still subject to rigorous quality control, in part because of changes in regulations after 2012. Carroll, for example, says Hims did “due diligence” in choosing its pharmacy and has been satisfied with the quality of the drugs. “We’ve seen extremely good feedback from our customers,” she says. “We haven’t had any undesirable side effects that we weren’t expecting.” According to Carroll, Hims hasn’t had to report any adverse events to the FDA.
Whats Next?
As researchers continue to discover new potential use cases for GLP-1 drugs and public interest and demand remain high, these drugs may be on the FDA’s official shortage list for months or even years. If the shortage ends, a type of compounding pharmacy (called a 503a) would have to stop production immediately, while 503b pharmacies, which typically produce on a larger scale, would have to stop production immediately. I would be 60 days oldEnding the shortage would require some major changes to this burgeoning cottage industry. None of the telehealth companies that sent prepared semaglutide to WIRED mentioned what might happen in this scenario during the intake process.
Many people taking compounded medications may be surprised if they are told they must switch to brand-name medications (and pay much higher prices) within a matter of months.
Even when the shortage officially ends, however, at least some of the telehealth companies don’t plan to abandon drug compounding. “We think there will be more and more demand for drugs, so that may lengthen the shortage list,” says Pat Caroll of Hims. “We are convinced that there is a path, even when we come off the shortage list, to supply these prepared drugs.”
Even the most skeptical suspect the situation isn’t going away anytime soon. With demand so high, Ryder suspects pharmaceutical companies will have to ramp up production to serve “basically 40 percent of the American population” before the shortage ends. Until then, Ryder suspects this telemedicine boom will continue unabated.
For now, the vials of compounded semaglutide ordered by WIRED sit undisturbed in the back of a refrigerator.
