The U.S. Food and Drug Administration (FDA) is taking a second look at its decision to ban compounding pharmacies from supplying cheaper versions of Eli Lilly and Company’s (LLY) highly successful weight loss and diabetes drugs. This news comes after the FDA faced legal challenges from compounding groups who argued that the ban was unjustified.
Initially, the FDA had prohibited compounding pharmacies from producing cheaper versions of these drugs, citing concerns about potential safety risks. However, compounding groups, including the Outsourcing Facilities Association and FarmaKeio Custom Compounding, filed a lawsuit against the FDA, arguing that the agency’s decision was “a reckless and arbitrary decision […] to deprive patients of a vital treatment for type 2 diabetes and obesity.” This lawsuit is currently on hold.
Eli Lilly, the pharmaceutical company that produces Mounjaro and Zepbound (both containing the drug tirzepatide), has been actively trying to control the distribution of its products. The company sent cease-and-desist letters to telehealth companies, compounding pharmacies, and medical spas, demanding they stop producing, selling, and promoting products that mimic their drugs. This action stemmed from concerns about potential safety issues and unauthorized distribution of tirzepatide.
The shortage of tirzepatide injections, branded as Mounjaro and Zepbound, has been ongoing since 2022, leading to increased demand for alternative sources. This shortage has put pressure on the FDA to reconsider its stance on compounding pharmacies.
The FDA’s reassessment of its original decision could have significant implications for patients seeking affordable access to these effective weight loss and diabetes treatments. The potential for more affordable options could increase access to these medications for individuals who might otherwise struggle to afford them. This situation will be closely monitored as the FDA weighs the potential benefits and risks of allowing compounding pharmacies to produce cheaper versions of Eli Lilly’s blockbuster drugs.
