Time To Crack Down On The Knock-Off Weight-Loss Drug Trade

Wegovy, Zepbound, and other GLP-1 agonists have given Americans an extraordinary new tool for losing weight and improving their health. But they’ve also given rise to a dangerous new public health threat—counterfeit medicines.

In a rush to capitalize on the popularity of these drugs, a number of third-party telehealth firms and online pharmacies have been selling unapproved “compounded” versions—many of which are made with potentially harmful ingredients from China.

The result is that countless Americans who believe they are buying safe, tested weight-loss therapies are in fact putting their health at risk. It’s time for lawmakers and regulators to do something about it.

Compounded drugs are different from traditionally manufactured medicines in that they are custom-made, often by a pharmacist, using the ingredients for a given medicine. As a result, they’re not approved by U.S. Food and Drug Administration regulators.

This is among the reasons why compounding is usually reserved for special circumstances—say, for a patient who can’t tolerate a standard-issue medicine, or when there’s not enough of the genuine good to meet patient demand.

And it was during a brief shortage of GLP-1s in 2022 that the first compounded versions reached the market.

That shortage has passed. And yet, a number of companies have continued to make and sell compounded GLP-1s—sometimes with disastrous results. As of July 31, the FDA had over 1,000 reports of adverse events linked to compounded GLP-1s.

The proliferation of knock-off GLP-1s is part of a larger problem—the continuous flow of counterfeit Chinese drugs into the United States. And it’s not just medicines. In recent years, counterfeit fentanyl from China has helped make the ongoing opioid epidemic worse.

President Trump reclaimed the White House in part because of his stated commitment to get tough on China. Putting the kibosh on compounded GLP-1s would help him follow through on that promise.

It’s what his voters are looking for. A recent poll by Fabrizio Ward found that 92% of Trump voters want the FDA to enact better protections against unsafe prescription drugs. Sixty-seven percent stand against expanded drug compounding “beyond narrow exceptions.”

The case for compounded drugs is even weaker when we consider that it’s easier than ever for consumers to secure legitimate, FDA-approved versions of the meds they need. Pharmaceutical companies are investing heavily in direct-to-consumer portals to deliver drugs to patients where they are, without waiting for an in-person doctor’s appointment and making a trip to a bricks-and-mortar pharmacy.

These platforms can also help save patients money—by cutting middlemen like pharmacy benefit managers, which claim roughly half of the money spent on prescription drugs, out of the supply chain.

PBMs exercise enormous control over what drugs an insurance plan covers—and how much patients pay for it at the pharmacy counter. For example, they tend to give preferential treatment to drugs with high list prices from which they can extract steep discounts or rebates from manufacturers. Cost-sharing is typically based on these artificially high list prices. So patients don’t directly share in the savings their PBM and insurer ostensibly negotiate on their behalf.

Both drug manufacturers and patients have much to gain by doing business directly, free of PBM interference. Patients could pit competing drug makers against one another, rather than being captive to the drug their insurer and PBM have selected for them. Manufacturers, meanwhile, would have the space to keep prices manageable because they wouldn’t have to line the pockets of a PBM.

This competition can lead to lower costs in the long run.

Critics of the direct-to-consumer model say that most patients can’t afford to pay for drugs out of pocket. But that’s not necessarily true. Lilly’s direct-to-consumer platform currently offers its GLP-1, Zepbound, for as little as $349 a month. That’s just slightly more than what the average American spent eating out in 2023, according to the Bureau of Labor Statistics.

The booming trade in illicit GLP-1s deserves a swift crackdown. Until that happens, too many Americans will continue to risk their health on potentially dangerous weight-loss medications.