Overview
Indianapolis-based pharmaceutical giant Eli Lilly has initiated lawsuits against four telehealth companies, alleging that they are selling unapproved products containing tirzepatide, a crucial ingredient in its weight-loss and diabetes medications, including the popular Mounjaro.
Details of the Lawsuits
- The lawsuits were filed in the U.S. District Court Northern District of California against Mochi Health, Fella Health, Delilah, and Henry Meds.
- A separate lawsuit against Willow Health Services was filed in the U.S. District Court for the Central District of California.
Allegations Against Fella Health and Delilah
In the complaint against Fella Health and Delilah, Eli Lilly claims:
- The companies conspired with Fella Medical Group to sell untested and unapproved weight-loss drugs.
- This practice diverts consumers from safe and effective medications, jeopardizing patient safety.
- Fella Health is accused of misleadingly marketing its products as safe and scientifically backed, despite lacking evidence from clinical trials.
FDA’s Position on Compounded Drugs
The FDA states that compounded drugs are not FDA-approved, meaning their safety, effectiveness, and quality are not verified before marketing. While compounded drugs can meet specific medical needs, they may pose risks to patients.
Claims Against Mochi Health
Eli Lilly’s lawsuit against Mochi Health alleges:
- Mochi Health is central to a conspiracy to produce and sell untested weight-loss drugs.
- The company is accused of switching patients to compounded tirzepatide with unapproved additives.
Responses from Telehealth Companies
A spokesperson for Mochi Health stated:
- Compounded medications are a legitimate part of clinical practice when tailored to individual patient needs.
- The company emphasizes compliance with FDA guidance and pharmacy regulations.
Similar Allegations Against Willow Health and Henry Meds
The complaints against Willow Health and Henry Meds echo those against Fella Health, claiming both companies mislead consumers about their untested drugs, risking patient safety.
Recent Legal Actions by Eli Lilly
Earlier this month, Eli Lilly also took legal action against over two dozen medical spas, wellness centers, and compounding pharmacies for selling products claiming to contain tirzepatide.
Industry Trends
In a related development, Noom has partnered with Eli Lilly’s LillyDirect pharmacy provider to enhance access to FDA-approved Zepbound for its members. This integration aims to improve weight management options for patients with prescriptions.
Additionally, Teladoc Health has entered a pharmacy integration agreement with LillyDirect to streamline access to Zepbound for its members enrolled in a Comprehensive Weight Care Program.
Conclusion
The ongoing legal battles highlight the complexities surrounding compounded medications and the pharmaceutical industry’s efforts to protect its patented products while ensuring patient safety.