Jessica DeBenedetto, a 43-year-old woman battling prediabetes since her 20s, recently started using compounded tirzepatide, a less expensive, generic alternative to Eli Lilly’s Zepbound. For her, the drug felt like a life-changer, especially after gaining weight due to IVF treatments. DeBenedetto noticed her appetite diminish and cravings subside, a shift she found both chemical and psychological. Yet, her optimism was short-lived. The FDA has removed tirzepatide from its shortage list and announced that pharmacies must cease compounding it, leaving only the expensive FDA-approved version available. For DeBenedetto, this decision feels like the rug has been pulled out from under her.
“I’m devastated this option is going away,” she said. Her doctor plans to switch her to compounded semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy. However, that solution is also temporary, as the FDA is likely to remove semaglutide from its shortage list in the near future. This regulatory shift is poised to affect countless individuals who rely on affordable, compounded GLP-1 drugs to manage weight and improve their health.
A Weight-Loss Revolution, Interrupted
GLP-1 drugs like tirzepatide and semaglutide represent a breakthrough in weight-loss medicine. Originally approved to treat type 2 diabetes, these medications have become transformative tools for weight management. By reducing appetite and increasing satiety, they’ve helped people lose significant weight while improving related health conditions like sleep apnea and even alcohol dependence. However, their meteoric rise in popularity has created accessibility challenges.
The high demand for GLP-1 drugs led to shortages of Ozempic, Wegovy, Monjauro, and Zepbound. With the brand-name medications costing thousands of dollars annually and insurance coverage often denied, many patients turned to compounded alternatives from specialized pharmacies. These pharmacies created cheaper versions using active ingredients sourced from chemical wholesalers. While the FDA warned about potential risks associated with non-FDA-approved drugs, compounded versions provided a lifeline for those who couldn’t afford or access brand-name medications.
The End of Compounded GLP-1 Drugs
In December, the FDA removed tirzepatide from its shortage list, signaling the end of compounded versions. Pharmacies now face a short grace period to halt production. Once this transition is complete, patients will need to switch to brand-name drugs, seek alternative treatments, or forgo medication altogether. The same fate awaits compounded semaglutide when it is eventually removed from the shortage list.
Industry groups like the Outsourcing Facilities Association (OFA) have pushed back against the FDA’s decision, even filing lawsuits to overturn it. Eli Lilly, on the other hand, has joined the FDA in defending the decision, emphasizing the need to ensure patients transition to FDA-approved drugs. According to Eli Lilly, addressing the cost barrier requires employers, insurers, and government entities to recognize obesity as a chronic disease and increase coverage for its treatment.
A Complex, Profit-Driven Ecosystem
At the heart of the issue is a multi-billion-dollar market. Drug manufacturers like Eli Lilly and Novo Nordisk hold market exclusivity for their GLP-1 medications, giving them a limited window to maximize profits before generic versions become available. Compounding pharmacies, meanwhile, have built a lucrative business by filling gaps in the market during shortages. Both parties have financial incentives to protect their interests, leaving patients caught in the middle.
“The real thing is expensive” is not a valid legal justification for compounding these drugs once shortages are resolved. However, some compounders may attempt to exploit regulatory loopholes by making small changes to the medications, such as adding ingredients like vitamin B12 or altering the method of delivery. These tactics could lead to further legal battles over what constitutes an “essentially” different drug.
Patients Face Uncertain Futures
The FDA’s decision introduces significant uncertainty for patients. Those who’ve relied on compounded medications must now navigate a complex web of affordability, insurance coverage, and availability. Telehealth companies like Ro have begun offering FDA-approved Zepbound at a slightly lower price point, but the cost remains prohibitive for many. Meanwhile, some patients may turn to less reputable sources, raising concerns about counterfeit or unsafe products.
Jessica DeBenedetto, like many others, finds the regulatory crackdown frustrating. “It’s ridiculous that the government would take compounded tirzepatide away,” she said, reflecting a common sentiment among patients who feel abandoned by a healthcare system prioritizing profits over access.
A Call for Industry-Wide Change
Experts argue that the current situation underscores the need for systemic changes in how GLP-1 drugs are priced and distributed. Melanie Jay, director of the NYU Langone Comprehensive Program on Obesity, highlights that many patients stop using these medications within a year due to high costs, insurance issues, and a lack of understanding about the long-term commitment required. Addressing these barriers could improve patient outcomes and reduce the stigma surrounding obesity treatment.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, points out that compounders play a vital role in addressing drug shortages and creating patient-specific medications. However, he cautions against exploiting regulatory loopholes, emphasizing the need for ethical practices within the industry. “There is a space in this world where compounders are important,” he said. “But the problem comes when they’re playing games and skirting essential copy regulations.”
The Path Forward
As the FDA phases out compounded GLP-1 drugs, the focus shifts to improving access to FDA-approved options. Drug manufacturers must work with insurers and policymakers to lower costs and expand coverage, ensuring that patients can afford the medications they need. At the same time, regulators must strike a balance between enforcing the law and allowing compounders to address genuine medical needs.
For now, the transition is unlikely to be seamless. Patients like DeBenedetto are left grappling with limited options and mounting frustration. As she succinctly put it, “Everything’s always about money, and it sucks.” While the healthcare industry wrestles with competing priorities, the hope is that this turbulent moment could eventually lead to a more equitable system for accessing life-changing medications.
