The GLP-1 Black Market Threatens U.S. American Patients and Patents
A black market in weight-loss drugs is flourishing in plain sight.
Rogue pharmacies and telehealth firms are flooding the United States with unauthorized knock-offs of semaglutide, tirzepatide, and other glucagon-like peptide-1 drugs.
Better known by brand names like Ozempic, Wegovy, Mounjaro, and Zepbound, the knock-off versions of these drugs are being manufactured with foreign ingredients, often sourced from China, and are not subject to approval by the U.S. Food and Drug Administration.
Representative Richard Hudson, R-N.C., and 81 of his colleagues recently wrote the FDA urging them to intervene.
They're right to sound the alarm.
Reports of overdoses, hospitalizations, and deaths tied to compounded drugs are mounting.
Yet these unregulated copies of patented medicines, often churned out in makeshift facilities or unlicensed pharmacies, continued to be falsely marketed as safe, personalized alternatives.
It's a scam that not only risks lives but undermines the intellectual property system that powers American innovation.
If compounders can rip off drug makers' years-in-the-making therapies without consequence, investment in future cures will evaporate.
Compounded glucagon-like peptide-1, or GLP-1, medications entered the market in late 2022, as demand for these breakthrough weight-loss drugs outstripped supply.
To manage the shortage, the FDA temporarily allowed compounding as a stopgap.
But by early 2025, the agency confirmed that commercial supply had stabilized — sharply limiting the legal basis for continued mass compounding.
Today, semaglutide, the active ingredient in Ozempic and Wegovy, can only be compounded in tightly defined circumstances.
The same is true for tirzepatide, the active ingredient in Mounjaro and Zepbound.
Still, compounders haven't stopped.
Instead, they've ramped up advertising campaigns, modifying patented formulas without FDA approval, and mass-producing unauthorized knockoffs under the false pretense of customized care.
The results have been predictably dangerous.
The FDA has issued multiple alerts, warning about the health risks associated with compounded GLP-1 medications.
Improper dosing has triggered serious side effects, including fainting, pancreatitis, and gallstones. Left to inject themselves at home without medical oversight, some patients have overdosed by five to 20 times the intended amount.
And it's not just how these drugs are used. It's what's in them. Many compounders rely on foreign suppliers operating with little or no regulatory scrutiny.
Some have been caught cutting corners. One reportedly allowed impurity levels of up to 15% per batch.
More than half of the foreign manufacturers that rushed in during the shortage never registered with the FDA. Some have never undergone inspection at all.
Others did and failed.
The human cost of this illicit operation is mounting. More than 900 adverse events and at least 17 deaths have been linked to compounded GLP-1 medications.
The longer this illegal market is allowed to operate, the greater the danger to patients, to innovation, and to the integrity of the U.S. healthcare system.
Fortunately, the government isn't short on options.
Federal agencies have the authority to crack down — from blocking suspect imports and prosecuting bad actors to pulling illegal products off the market.
What's missing is urgency.
If we care about protecting patients today and preserving the next generation of medical breakthroughs, that has to change.
Compounders are trampling intellectual property rights — the very protections that make it possible for innovative medicines to reach patients in the first place.
The companies that have developed GLP-1s spent decades, and billions of dollars, bringing them from the lab through the regulatory process and to market.
That investment was made under a system that offers time-limited exclusivity in return for high-risk innovation.
Letting compounders hijack that window undermines the model entirely — and threatens the development of tomorrow's cures.
America already has a system that works.
When patents expire, FDA-approved generics come to market safely, affordably, and legally. The recent launch of a generic version of Victoza, another GLP-1 drug, proves that competition doesn't require cutting corners or compromising safety.
What compounders are selling isn't competition.
It's a shortcut that endangers lives, violates the law, and threatens the innovation pipeline that makes American medicine the best in the world.
President Trump has long positioned himself as a champion of law and order, American innovation, and supply chain sovereignty.
This is his chance to draw a hard line: crack down on compounders, strengthen patent enforcement, and block unregulated, foreign ingredients from entering our borders.
Sally C. Pipes is President, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is "The World's Medicine Chest: How America Achieved Pharmaceutical Supremacy - and How to Keep It." Follow her on X @sallypipes. Read Sally Pipes' Reports — More Here.