Eli Lilly and Novo Nordisk have both recently taken legal action against companies selling compounded versions of drugs, often alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. This June, Eli Lilly initiated six lawsuits, following 10 other lawsuits that the pharmaceutical company began last fall. In one, filed against a company selling compounded GLP-1s online, it alleged that passing compounded drugs off as having identical active ingredients as its products was “not merely deceptive—it’s dangerous.”
“Telehealth providers and compounding pharmacies that are claiming to offer or sell unapproved compounded products claiming to contain ‘semaglutide’ are sourcing their ingredients from entities other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. “As the FDA has cautioned, unapproved compounded ‘semaglutide’ drugs do not have the same safety, quality, and effectiveness assurances as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use a compounded drug if an approved drug is available.”
“There’s huge safety implications,” Ryder says. In 2012, a compounding pharmacy caused a fungal meningitis outbreak that killed at least 64 people, among the worst pharmaceutical drug-contamination disasters in the United States. The supervisory pharmacist who oversaw the manufacture of this medicine was sentenced to prison time, and the event led to tightened oversight and licensing requirements for compounders.
Some of the leading compounding pharmacies that produce GLP-1 medications have landed in trouble for their practices. Hallandale Pharmacy, a popular supplier—two of my four vials came in its sleek blue packaging—has run into trouble with regulators for past infractions, which included concerns over record-keeping and facility conditions. It has received warning letters from the FDA, although the last one was closed out in May 2022, which means the FDA found that it had addressed outstanding issues. (Hallandale declined requests for comment.)
The FDA has found issues with pharmaceutical companies, too, though. In 2023, FDA inspectors found bacterial contamination at a Novo Nordisk production plant in North Carolina. “Leadership addressed immediately, and the site received FDA approval for full production for market in August 2023,” Novo Nordisk’s Bennett says.
Compounding advocates say that, although the drugs are not FDA-approved, they are still subject to rigorous quality control, in part due to post-2012 rule changes. Carroll, for example, says Hims did “due diligence” when choosing its pharmacy and that it has been satisfied with the medication quality. “We’ve seen an extremely good response from our customers,” he says. “No untoward side effects that we didn’t anticipate.” According to Carroll, Hims has not had to report any adverse effects to the FDA.
What’s Next?
As researchers continue to discover new potential use cases for GLP-1 drugs, and public interest and demand remains high, these drugs may be on the FDA’s official shortage list for months or even years to come. If the shortage ends, one type of compounding pharmacy (called 503a) would be required to stop production immediately, while 503b pharmacies, which typically produce on a larger scale, would have 60 days. An end to the shortage would require some substantial pivots within this booming cottage industry. None of the telehealth companies that sent compounded semaglutide to WIRED made mention of what might happen in this scenario during the intake process.
Many people who take compounded drugs may be taken by surprise if they are told they must switch to brand names—and pay much higher prices—within a matter of months.
However, even when the shortage does officially end, at least some of the telehealth companies do not plan to pivot from compounding. “We believe there’s going to be more and more demand for the medication, so that may actually prolong the shortage list,” says Hims’ Pat Caroll. “We are convinced there’s a pathway, even when it comes off the shortage list, to supply these compounded medications.”
Even compounding skeptics suspect that it’s not going away anytime soon. With demand so high, Ryder suspects pharmaceutical companies will need to ramp up production to serve “basically 40 percent of the US population” before shortages end. Until then, Ryder suspects this telehealth boom will continue unabated.
For now, the vials of compounded semaglutide WIRED ordered are sitting in the back of a fridge untouched.
