Compounding Pharmacies and the Future of Weight-Loss Drugs
This week signals a pivotal moment for compounding pharmacies that have been producing versions of Eli Lilly’s medications Zepbound and Mounjaro. Despite regulatory changes aimed at curbing these practices, many online pharmacies continue to offer compounded versions of tirzepatide, the active ingredient in these drugs.
The Current Landscape
Several pharmacies, including well-known platforms like Amble, EllieMD, Willow, and Mochi Health, are still promoting their formulations of tirzepatide. While some players like Ivim have ceased onboarding new patients, others, such as Mochi Health, maintain their operations uninterrupted.
According to Mochi Health’s CEO, Myra Ahmad, the company leverages a network of approximately 500 healthcare providers to tailor prescriptions that suit individual patient needs. Ahmad commented, “It can be different dosing schedules… some patients prefer to go up in dosage much more slowly.” This level of personalization is touted as a significant advantage of compounding over standard formulations.
Understanding Compounding
Compounding is a process where pharmacies mix drug ingredients to create customized versions for patients. This can be essential for those with allergies to specific ingredients, or patients needing alternative delivery forms, like liquid medication when only capsules are available. Furthermore, during drug shortages, compounding can temporarily provide necessary supplies to address patient needs.
Market Dynamics and Regulatory Challenges
In recent years, compounded versions of Lilly’s Mounjaro and Zepbound, as well as Novo Nordisk’s Wegovy and Ozempic, became prevalent because the U.S. Food and Drug Administration (FDA) cited shortages of the branded versions. This situation spurred a burgeoning compounding business within the weight-loss and diabetes medication sector.
However, the FDA declared in late 2022 that supplies of Mounjaro and Zepbound were stable, leading to new regulations. Smaller compounding pharmacies were given until early March to comply, while larger ones faced immediate restrictions. Under the new FDA guidelines, larger pharmacies are now barred from compounding tirzepatide altogether, while smaller facilities are restricted from creating formulations that closely mimic commercially available drugs.
Implications for Patients and Pharmacies
Mochi Health asserts that all its compounded prescriptions are individualized, including those with dosages that differ from the standard offerings of Zepbound. Nonetheless, this continues to blur the lines as other pharmacies, such as EllieMD, explore options like combining tirzepatide with vitamin B12.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, noted that formulations not commercially available are generally acceptable under FDA guidelines. However, he adds, “combining two drugs into one… would be considered a copy under a strict reading of FDA guidance.”
Some compounding pharmacies, like Town & Country Compounding Pharmacy, have ceased to offer tirzepatide due to potential legal risks, despite their patients expressing dissatisfaction. Their previous pricing was significantly lower than the standard rates for Zepbound, making the withdrawal particularly impactful.
The Road Ahead
The FDA will play a crucial role in enforcing these recent regulations. Although Eli Lilly may pursue legal action against pharmacies that continue to compound tirzepatide, previous attempts have not always proven successful. Ahmad believes her company is on stable ground, emphasizing the established patient-physician relationships that empower treatment decisions.
In the upcoming months, the situation will become clearer, particularly as the FDA sets a deadline for the cessation of mass compounding of semaglutide, active in Novo Nordisk’s Ozempic and Wegovy, by the end of May. Hims & Hers Health has stated it will comply but will continue to support personalized regimens.
As this complex landscape evolves, both patients and pharmacies must navigate the shifting regulatory framework governing compounded medications, which will ultimately shape access to vital treatments.
– Reporting contributed by CNBC’s Leanne Miller
