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Indianapolis-based Eli Lilly and Co. is suing medical spas, wellness centers and compounding pharmacies in various U.S. states that sell unapproved versions of its blockbuster diabetes drug Mounjaro, which is frequently used off-label for weight loss.
In lawsuits Lilly said it filed in federal courts spanning several states, it accused four businesses of selling compounded versions of Mounjaro, violating state laws because the drugs lack approval from the U.S. Food and Drug Administration.
Lilly is accusing another six companies, mostly medical spas and wellness centers, of trademark violations, false advertising and unfair competition by selling knockoff drugs under the Mounjaro name.
The lawsuits are intended to protect patients, Lilly said in a written statement.
The company “cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product,” it said, referring to Mounjaro’s active ingredient.
Novo Nordisk took similar legal action against companies selling versions of its weight-loss drug Wegovy earlier this summer as demand has kept some doses in short supply.
Both Novo and Lilly have struggled to keep up with demand for the drugs, which are on track to become some of the best-selling of all time. Wegovy and Mounjaro are only available with a prescription and are meant for patients with obesity or diabetes. The drugs can cost more than $10,000 a year without insurance, leading some consumers to seek out cheap alternatives. Others have turned to unapproved medications sold by medical spas and wellness centers frequently touted on social media platforms.
Better Life Pharmacy, Revive Rx, Rxcompoundstore.com and Wells Pharmacy Network violated state laws by selling compounded versions of tirzepatide in Florida, Texas and over a dozen other states, Lilly said.
The company said it also asked courts to intervene to stop Georgia Weight Loss & Aesthetics, Graze Anatomy & Associates, Renew MedSpa, Revival Aesthetics and Wellness, Sensational Skin Centers and Totality Medispa from selling unapproved products under the Mounjaro brand, which Lilly owns the rights to.
“When companies circumvent the drug-approval process, safety and efficacy are, at best, unknown,” Lilly said in its suit against Better Life Pharmacy. “The danger is not merely theoretical, as manufacturing and distribution of unapproved new drugs of unknown quality has endangered or adversely impacted public health.”
The company expects U.S. regulators to approve Mounjaro for obesity this year.
Lilly shares have climbed 57% in 2023, well above the 16% gain of the S&P 500 index. They closed at $574.96 each on Tuesday.
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A woman in our neighborhood claims she has been using a knock-off version of Mounjaro for several months and is seeing great results (she does look as though she has lost some weight). She buys the supply from “a guy she knows” and meets him in a parking lot once a month. Interestingly, this same woman refused to get a COVID vaccination because “I have no idea what is in the vaccine.” To top it all off, she has spent most of her professional career in pharma sales.
Lilly is charging over $13,000 per year for a life changing drug that most insurance plans won’t cover yet at the same time clamping down on a safe option that is available and while not cheap is affordable for most.
Who paid for the development of that drug? They are owed the opportunity to cover that cost and then make a profit, as well as protect their R&D. That is how businesses are run. We should be thankful companies like Lilly exist so R&D continues to fight illness.
There are patents for a reason. Why should someone be able to make a knock-off to capitalize on years and hundreds of millions of dollars spent by the developer? Then who would ever do that kind of research?
Lilly’s actions in filing lawsuits against businesses selling unapproved compounded versions of Mounjaro are in line with the need to protect public health, uphold regulatory standards, and defend intellectual property rights. These actions serve the interests of both the company and the patients who rely on safe and effective medications.
Furthermore, state laws often require that drugs comply with FDA regulations, and violating these laws can have serious consequences, why aren’t the states enforcing their own state laws for the benefit of public safety, or just do away with the laws.
It is crucial to strike a balance between the need for rigorous drug regulation and the necessity of ensuring access to essential medications. Instead of resorting to legal action, Lilly could explore alternative ways to collaborate with compounding pharmacies to ensure that patients who genuinely require Mounjaro can access it safely while maintaining FDA standards. This approach would better serve both patient well-being and public health interests.
Ultimately, Lilly’s actions highlight the complex and delicate balance between regulatory compliance and patient access to vital medications. A more nuanced approach that considers the needs of patients who rely on compounded drugs may be a more constructive way forward.