Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid mounting concerns over their potential safety risks.
On Friday, a group of more than 80 bipartis
an lawmakers asked the US Food and Drug Administration to stop counterfeit and copycat versions of GLP-1 drugs like Wegovy and Zepbound from flooding the market — a problem that emerged over the last year.
“We are concerned about recent reports revealing a surge in illegal and counterfeit anti-obesity medications,” they wrote in a letter to FDA Commissioner Marty Makary. “Undoubtedly, illegal counterfeit medications pose an increased risk to patient safety with sometimes fatal consequences.”
The group — spearheaded by Representatives Richard Hudson of North Carolina and Herb Conaway of New Jersey — asked the agency to ramp up enforcement over illegally imported weight-loss drugs. They suggested issuing warning letters and better monitoring non-compliant online retailers and so-called compounding pharmacies that sell the medicines.
The lawmakers also said the FDA should work in tandem with US Customs and Border Patrol agents to stop Chinese entities from shipping unsafe weight-loss drugs into the US. They requested an update on the FDA’s efforts by July 30, given the “urgency” of the situation.
A spokesperson for the FDA said the agency will work with the US Department of Health and Human Services to provide a “complete and thorough” response to the issues raised in the lawmakers’ letter.
“Any effort to undermine America’s supply of safe medicines is an issue that FDA takes seriously,” the spokesperson said. “And we are deeply committed to strengthening the oversight of imported products at US ports of entry.”
In recent years, the popularity of GLP-1 drugs has led to an explosion of copycats and counterfeits made by companies seeking to capitalize on the hype.
State-licensed pharmacies were temporarily allowed to make copies of the drugs during a supply shortage, but are no longer permitted to do so after Novo Nordisk A/S and Eli Lilly & Co. boosted production. Still, some pharmacies have refused to wind down their operations while others have pivoted to selling the drugs in lower doses in order to avoid regulatory scrutiny.
Counterfeit drugs are made by unregistered entities typically using illegally imported ingredients. As recently as April, there continue to be instances when counterfeit Ozempic pens covertly enter the drug supply chain undetected. Some patients are also purchasing ingredients directly from online sellers in an attempt to make the drugs themselves at home.
In both cases, the medications don’t go through the same rigorous approval process as brand-name drugs made by Novo and Lilly. Experts worry the lack of oversight is putting patients at risk. The FDA has said it’s aware of hospitalizations potentially linked to the copycat drugs, but that adverse events are likely being underreported.
“We support the bi-partisan call for the FDA to crack down on counterfeit and illegally sold weight-loss drugs,” said a spokesperson for Hims & Hers Health Inc., one of the telehealth firms that sells compounded GLP-1s. “We appreciate lawmakers’ recognition that legitimate compounded medications dispensed by state-regulated pharmacies are not counterfeit. Patient safety must always come first.”
Novo and Lilly have discouraged consumers from using compounded and counterfeit products, including suing telehealth firms that sell the copycat versions and working with border agents to seize illegal shipments. Under the Biden administration, the companies repeatedly urged the FDA to take action, but the agency mostly limited its actions to issuing consumer warnings — even as its top drug official publicly acknowledged safety concerns.
Under the Trump administration, the HHS has also focused more heavily on other issues, such as banning food dyes and examining vaccine schedules.
Meanwhile, lawmakers are ramping up their calls for action. State attorneys and other lawmakers have sent letters to the FDA and Federal Trade Commission advocating for greater transparency around the treatments and more scrutiny around marketing practices.
Muller writes for Bloomberg.