Shortages created opportunities for counterfeits

In November, Novo Nordisk announced that it was aware of at least 10 people who had died after taking compounded copies of its drugs in the US. The news was just the latest in a cavalcade of headlines about copycat glucagon-like peptide 1 (GLP-1) agonists. The blockbuster drugs used for weight loss and to treat diabetes are in such high demand that Novo Nordisk and Eli Lilly and Company, the companies that sell them, have had difficulty keeping up. The resulting shortages have inspired both authorized copies and illegal counterfeits all over the world. And GLP-1 agonists aren’t the only drugs being copied.

The fight for US sales

For most of 2024, it was legal for other companies in the US to sell tirzepatide, the active peptide in Zepbound and Mounjaro, and semaglutide, which is in Wegovy and Ozempic—even though these drugs are still under patent protection. That’s because when the US Food and Drug Administration declares a drug shortage, licensed compounding pharmacies can legally formulate and sell generic copies.

The FDA put both peptides on its shortage list in 2022. Semaglutide is still on that list, while the FDA lifted its shortage designation for tirzepatide in October. The FDA is reviewing the shortage designation in response to lawsuits from compounders.

Tenille Davis, chief advocacy officer at the Alliance for Pharmacy Compounding, says there is no shortage of tirzepatide or semaglutide, the active pharmaceutical ingredients. “The shortage is in the finished dosage form of those products.”

Compounding pharmacies have done brisk business in web-based prescriptions for GLP-1 drugs, often charging a fraction of the list price. According to Davis, it’s hard to say how many people obtain medication this way. “Because compounded drugs aren’t paid for by any third parties, there’s no reporting requirements, so we have no idea the size of the market,” she says.

But there is considerable evidence of bad actors in that market. The National Association of Boards of Pharmacy (NABP), which advises state-level regulators and evaluates digital pharmacies for accreditation, says that of tens of thousands of online pharmacies it has assessed, 95% were operating illegally. According to Al Carter, the NABP’s executive director, unscrupulous compounders sometimes use a product with chemical differences from the API—for example, a salt of tirzepatide that is meant for research and not held to pharmaceutical-grade standards—or fail to follow correct manufacturing practices. Outright counterfeiters, meanwhile, sell look-alikes that contain no medicine at all.

Pharma companies took legal action against some of these copycats this year. Lilly sued medical spas and wellness centers that sold compounded tirzepatide for weight loss. Novo Nordisk petitioned the FDA to prohibit compounding of its peptides. And Gilead Sciences sued two pharmacies in New York City where, the company alleged, a pharmacist had refilled empty bottles of the company’s branded HIV medications with fake pills or other medications.

Compounders have a role to play in legitimate drug supply, Davis says; they periodically fill in shortfalls of FDA-approved drugs, such as a pediatric antibiotic infusion that was in short supply last year amid a surge of pneumonia. But counterfeits and poor compounding practices can hurt people, as when tainted steroid injections from a compounding pharmacy caused a meningitis outbreak that killed dozens in the US in 2012.

A global problem

Counterfeits and copies are a global phenomenon. The World Health Organization (WHO) warned consumers in June about a batch of fake Ozempic that had made its way into the legitimate drug supply in Brazil, the UK, and the US. After Novo Nordisk announced that it would limit sales of semaglutide in China to head off deeper shortages elsewhere, China’s National Medical Products Administration cracked down on legally dubious versions of the drug.

Fake medicines aren’t limited to GLP-1 drugs. All told, the WHO estimated in 2017 that about 1 in every 10 medical products sold in low- and middle-income countries is substandard or completely fake and that falsified antibiotics could kill on the order of 100,000 children annually. This year, Nigeria’s National Agency for Food and Drug Administration and Control seized counterfeits of monoclonal antibody drugs, like the cancer medicines Tecentriq and Avastin, along with falsified antibiotics. In October, the Indian Pharmaceutical Alliance petitioned the country’s Supreme Court to give greater power to government agencies so they can prosecute sellers of fake drugs.

GLP-1 drug shortages will end eventually; both Lilly and Novo Nordisk have made big investments in scaling up production. But dubious drug sellers will likely persist as long as customers find some medicines unaffordable. Carter says that having monitored web pharmacies for a decade, the NABP has observed several waves of illicit prescription sales, selling “whatever is in the press that these bad actors figure out they can make some money on.”