Indiana joins states calling for the FDA to clamp down on counterfeit weight loss drugs

Over 30 state attorneys general including in Indiana, Kentucky, and Ohio have urged the Federal Food and Drug Administration, or FDA, to take action against “bad actors” selling counterfeit weight loss drugs.

High demand for drugs like Ozempic, Mounjaro, Zepbound and Wegovy paired with a shortage has created a market for counterfeits, according to the letter.

The letter outlines concerns about counterfeit versions of drugs getting into the supply chain, online retailers illegally selling active ingredients, or pharmacies that “cut corners” in making copy versions of the drugs.

Chelsea Shover, an assistant professor in residence at the University of California Los Angeles School of Medicine studying counterfeit drugs and substance use disorders, said that without a lab it can be impossible to know if the drug you’re accessing is the real thing.

“I think the risk with counterfeit is you might get nothing, you might get the wrong thing, you might get the wrong amount of the thing you want,” she said. “Or you might just get something that introduces new harms or risks.”

Shover advised against trying to access weight loss drugs without a prescription.

A spokesperson for Eli Lilly, which manufactures the weight loss drug Mounjaro, urged state and federal regulators to do more to block illegal foreign shipments from coming into the country.

“These products frequently come from illicit foreign suppliers and are sold to unsuspecting patients online, through telehealth websites and social media, or at medspas and wellness centers,” the spokesperson said. “ These unapproved drugs may be contaminated with dangerous bacteria or endotoxins or contain no medicine, the wrong medicine, or too much or too little medicine.”

But some have more complicated feelings about the calls for a clamp down on weight loss drugs.

Compound pharmacies — which manufacture copy versions of weight loss drugs — worry they are being lumped in with the illegal market.

During a shortage, compound pharmacies are legally allowed to help manufacture copies of drugs in order to help meet patient needs.

Those drugs are often produced and sold at a fraction of the cost compared with those sold from producers like Eli Lilly or Novo Nordisk, which manufactures Ozempic.

A federal shortage has been in place since 2022 for a variety of popular weight loss drugs, but the FDA recently moved to declare those shortages over. That means that compound facilities have within 60-90 days to stop producing the copy drugs or face enforcement.

A trade group representing compound pharmacies has sued the FDA, arguing the shortage is still ongoing.

Tenille Davis, the chief advocacy officer for the Alliance for Pharmacy Compounding, said she worries the public doesn’t know the difference between counterfeit drugs and legally compounded ones.

“What's happened a lot, and it seems pretty intentional from the part of drug makers, is the conflation between counterfeit and compounding,” she said.

The letter from the State Attorneys General does call for increased enforcement against compound pharmacies potentially participating in the illegal market.

“While many compounding pharmacies adhere admirably to the best practices of their profession, some have cut corners in pursuit of a quick profit,” the letter from AGs noted. “These pharmacies can be exempt from certain regulatory provisions of the Federal Food, Drug, and Cosmetic Act, but they are not exempt from the provision deeming drugs produced under insanitary conditions as ‘adulterated’.”

The letter included a link to FDA guidance, which noted insanitary conditions that had been observed at compound facilities. That guidance was generated in 2020 before compound facilities began responding to the shortage of weight-loss drugs.

“Just like in any industry, bad actors in any industry should have action taken against them by the appropriate regulatory body,” Davis said. “So if there are compounders that are doing things that they are not supposed to do, we support the Board of Pharmacy taking action against that pharmacy to stop that behavior.”

Because of the ongoing lawsuits, Davis said there is no “drop dead date” for when compounders have to stop producing copies of weight loss drugs. But she said compounded versions of drugs will always be the second choice for a prescriber.

“If these drugs are truly available in the marketplace, FDA-approved versions of medications are always the first choice for patients,” she said.

Contact Health Reporter Benjamin Thorp at bthorp@wfyi.org.

Side Effects Public Media is a health reporting collaboration based at WFYI in Indianapolis. We partner with NPR stations across the Midwest and surrounding areas — including KBIA and KCUR in Missouri, Iowa Public Radio, Ideastream in Ohio and WFPL in Kentucky.