The market for illicit weight-loss drugs is booming in plain sight. Law enforcement officials will have no choice but to act soon.
In July, telehealth firm Hims & Hers was hit with a securities lawsuit alleging that the company sold unapproved knock-off compounded versions of Wegovy in violation of its agreement with the drug’s developer, Novo Nordisk.
The case comes a month after Novo terminated its partnership with Hims & Hers, accusing the firm of “fail[ing] to adhere to the law which prohibits mass sales of compounded drugs.”
Sally C. Pipes is president, CEO and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute.
Compounded weight-loss drugs have flooded the market — and put patient safety at risk. These knock-offs also disrupt the incentives that entice drug companies to spend billions of dollars on research.
Turning a blind eye to illegally compounded drugs could result in fewer innovative drugs being developed.
GLP-1 agonists like Wegovy are among the most powerful tools yet invented for fighting obesity — a condition affecting roughly two in five adults in this country.
They could also be a boon to America’s health care finances over the long-term. Obesity costs us an estimated $173 billion a year. A medicine that can reduce the prevalence of obesity could prevent a host of expensive medical problems before they arise — including everything from heart disease and stroke to cancer and diabetes.
But for GLP-1s to fulfill their potential, it’s critical that the U.S. Food and Drug Administration retain strict control over the quality and safety of these breakthrough therapies. To date, that hasn’t happened.
In response to a 2022 shortage of the drugs, a number of telehealth brands and less-than-reputable pharmacies began making and selling their own “compounded” copies of GLP-1s to meet demand.
Unlike traditionally manufactured medicines, such compounded drugs don’t have to go through the standard FDA approval process. This makes them inherently risky — which is why the FDA only permits compounding in special situations, such as drug shortages.
Yet even now that the GLP-1 shortage is over, compounders are continuing to make and sell their own copies of these medicines. The result is that many Americans are unknowingly relying on an unapproved medicine of dubious quality, safety and origin — even though safer alternatives are widely available.
The risks posed by compounded drugs are more than hypothetical. As of April, the FDA had received about 1,000 adverse event reports linked to compounded GLP-1 medicines. Compounded semaglutide — the active ingredient in Wegovy and Ozempic — has been associated with numerous deaths.
Between 2019 and 2023 — a period in which compounded GLP-1s became available — the nation’s poison control centers saw a 1,500% uptick in calls involving semaglutide.
There is also significant evidence that many compounded GLP-1s sold in the United States contain active pharmaceutical ingredients obtained from foreign sources that aren’t registered with the FDA.
An analysis by the Partnership for Safe Medicines, for instance, looked at import records from 2023 to 2025. The researchers found “199 shipments of semaglutide imports from manufacturers that had no registered drug establishment with FDA, meaning that FDA has no idea they should be inspecting them.”
In other words, large quantities of GLP-1 ingredients of dubious quality are entering the country without the FDA’s knowledge. They’re finding their way into seemingly safe weight-loss medicines. And patients are none the wiser.
But there’s more at risk here than patient safety. The economics of drug development hang in the balance.
It takes $2.6 billion, on average, to bring a drug from the lab through the regulatory process and to the patient’s bedside. Why would investors and companies put such huge sums toward drug development if compounding pharmacies and telehealth start-ups can simply ignore innovators’ intellectual property rights and sell their own untested, potentially harmful copies?
The United States has led the world in pharmaceutical innovation for decades in large part thanks to our strong intellectual property system and world-leading regulatory standards for drug quality and efficacy.
The explosion in knock-off GLP-1 sales has weakened both of these foundational pillars.
Until federal regulators put an end to this illicit drug trade, both patient safety and the rule of law will remain in needless peril.
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.
