Indianapolis-based pharmaceutical behemoth Eli Lilly has filed lawsuits against four compounders claiming that they sold unapproved products that contain tirzepatide, a key ingredient in the company’s weight-loss and diabetes drugs, including top-seller Mounjaro.
The lawsuits against Mochi Health, Fella Health and Delilah, and Henry Meds were filed in the U.S. District Court Northern District of California San Francisco Division, while the lawsuit against Willow Health Services was filed in the U.S. District Court for the Central District of California.
In the complaint against Fella Health and Delilah, Lilly claims the company “engaged in a conspiracy with doctor groups Fella Medical Group P.A. and Fella Medical Group P.C. (collectively ‘Fella Medical Group’) to sell untested, unapproved weight loss drugs, diverting consumers from safe and effective medicines and risking patient safety.”
The complaint alleges, “Fella’s scheme centers around tirzepatide, the active pharmaceutical ingredient in Plaintiff Eli Lilly and Company’s Mounjaro and Zepbound. Lilly’s medicines, which have undergone 37 clinical trials, are the only FDA-approved tirzepatide medicines, and Mounjaro and Zepbound are approved only for under-the-skin injection and without additives like glycine or l-arginine.”
Additionally, Lilly claims Fella “unfairly and deceptively markets and sells its oral and injectable tirzepatide as drugs that are safe, effective and backed by science when none of that is true. Fella cites to the results of Lilly’s clinical trials in support of these claims. But Lilly’s clinical trials did not evaluate oral tirzepatide or tirzepatide combined with glycine or l-arginine and Lilly is not aware of any clinical trials that have.”
On its website, the FDA says, “Compounded drugs are not FDA approved, which means the agency does not verify their safety, effectiveness or quality before they are marketed. Although compounded drugs can serve an important medical need for certain patients, they also may pose a risk to patients.”
Lilly’s lawsuit against Mochi Health alleges, “Defendant Mochi Health Corp (‘Mochi Health’) is at the heart of a conspiracy and enterprise to make, prescribe and sell untested, unproven weight-loss drugs that risk patient safety and drive patients away from proven, tested medicines, all through a web of entities that Mochi Health and its owners control.”
“Compounded medications have been, and always will be, a well-established part of clinical practice in the U.S. Their use remains appropriate and legal when tailored to individual patient needs and prescribed by a licensed medical provider, not as mass-market substitutes for branded medications,” a spokesperson for Mochi Health told MobiHealthNews in an email.
“Mochi’s licensed physicians alone determine which treatments, whether brand-name GLP-1 medications, compounded alternatives, or non-medicinal options, are best for their patients, based on each person’s medical history and unique needs. Mochi’s care model remains compliant with FDA guidance and pharmacy regulations and we’re dedicated to keeping these treatments accessible for our patients.”
The complaints against Willow Health and Henry Meds are similar, in which Lilly alleges that both companies “deceive consumers about its untested, unapproved drugs, risking patient safety and diverting unsuspecting consumers from safe and effective medicines.”
According to Reuters, earlier this month, Lilly took legal action against more than two dozen medical spas, wellness centers and compounding pharmacies for selling products that they claimed contained tirzepatide.
THE LARGER TREND
Earlier this month, Noom entered into an agreement with Eli Lilly’s LillyDirect pharmacy provider Gifthealth to help improve access to FDA-approved Zepbound (tirzepatide) single-dose vials for Noom’s members with an on-label prescription from a doctor.
The integration with the LillyDirect pharmacy provider expanded Noom’s approach to weight management by allowing an option for members whose doctors prescribe FDA-approved medications.
In March, Teladoc Health entered into a pharmacy integration agreement with Eli Lilly’s LillyDirect pharmacy partner, Gifthealth, which was intended to help streamline access to Zepbound medication for members enrolled in a Comprehensive Weight Care Program.
The move was meant to provide safer and more seamless access to GLP-1s for members without insurance coverage.
Another company offering compounded weight-loss medications is the direct-to-consumer virtual care company Hims & Hers.
In February, Hims & Hers received backlash to its 60-second commercial dubbed “Sick of the System” that ran during the Super Bowl on Fox. The ad states that “obesity is America’s deadliest epidemic” and claims that “something is broken, and it’s not our bodies; it’s the system.”
It then goes on to say the $160 billion weight loss industry “feeds on our failure.” It says there are medications that work that are “priced for profits,” and the system “wasn’t built to help us” but to “keep us sick and stuck.”
The commercial then presents Hims & Hers as a solution, stating that the company “offers life-changing weight loss medications that are affordable and doctor-trusted.”
