Eli Lilly Sues Alleged Purveyors of Counterfeit Mounjaro

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Facts

  • On Thursday, American drugmaker Eli Lilly said it filed six separate lawsuits against those it claims are selling products containing tirzepatide, the active ingredient in their diabetes drug, Mounjaro, and weight-loss prescription, Zepbound.1
  • Eli Lilly alleges that spas and wellness centers are selling counterfeit or compounded versions of tirzepatide. They claim that the accused falsely labeled their products as Mounjaro or Zepbound or as having US Food and Drug Administration (FDA) approval.2
  • The company says that lab tests found that the counterfeit and compounded tirzepatide raised efficacy and safety concerns. It noted that some contained bacteria and impurities, and, in one case, the purported drug contained only sugar alcohol.3
  • Warning that such unauthorized products could cause 'serious harm,' Eli Lilly warned consumers against purchasing the drug from social media or other outlets like spas and wellness centers. Some unlicensed sellers allegedly offer oral tirzepatide, which no regulatory body has approved.4
  • The National Association of Boards of Pharmacy has said that the supply of weight loss drugs has not been able to keep up with the demand, which 'illegal actors' are reportedly taking advantage of. Lilly filed similar lawsuits in October and September 2023.5
  • The FDA said in March that it had received over 100 reports of adverse effects from counterfeit tirzepatide and semaglutide, the generic ingredient in Novo Nordisk's Ozempic and Wegovy. Novo Nordisk filed nine suits against alleged unauthorized compound sellers in May.5

Sources: 1Reuters, 2Wsj, 3ABC News, 4Eli Lilly and Company and 5Forbes.

Narratives

  • Narrative A, as provided by Washington Post. A broken insurance and medical system in America has driven desperate patients to counterfeit weight loss drugs. Over 40% of Americans are obese, and they are being shut out by cost-averse insurers and a recalcitrant federal government, which treats obesity drugs as cosmetic interventions rather than medical ones. It would be much better to allow insurers and Medicare to negotiate for these drugs in bulk — prices would be driven down as generics and cheaper versions are gradually introduced.
  • Narrative B, as provided by Vanity Fair. Drug counterfeiting is a scourge that involves multinational criminals and middlemen who illicitly divert pharmaceuticals from the supply chain. This problem isn't due to the failures of insurers or manufacturers but to the poor enforcement of the law and bad policy. By declaring a shortage of weight-loss drugs, the FDA opened the floodgates to compounders, who began hawking drugs of varying quality. As these drugs have now entered the legitimate supply chain, expanding access would do more harm than good.

Predictions