Weight-Loss Drug Market Faces Major Shakeup
FDA crackdown on compounded GLP-1s leaves patients scrambling.
The weight-loss drug market is experiencing a seismic shift as the FDA cracks down on compounded versions of popular medications like Ozempic and Mounjaro, potentially disrupting access for millions who rely on telehealth services for prescriptions. The move has left many questioning their next steps.
Telehealth Boom and Potential Risks
Telehealth companies like Hims & Hers Health emerged as intermediaries, connecting consumers with compounded GLP-1 medications. This model allowed individuals to bypass traditional doctor visits, obtaining prescriptions through online consultations. Hims & Hers Health even aired a Super Bowl ad pitching itself as the solution. But this ease of access came with risks.
A January 2025 study revealed that nearly half of 79 websites selling compounded GLP-1s failed to disclose potential side effects, including nausea and pancreatitis. Alarmingly, 13% didn’t even reveal their drugs were compounded, potentially misleading consumers.
FDA Intervention and Market Disruption
Citing an end to drug shortages, the FDA mandated that compounding pharmacies cease production of compounded semaglutide and tirzepatide. This action sent shockwaves through the telehealth industry, with Hims & Hers’ stock price plummeting 25%. As a result, millions could be cut off from their medications.
“By now, all compounding pharmacies are technically required to stop making these drugs.”
A Patient’s Story
Rob Enderle, a 37-year-old delivery driver, credits compounded semaglutide with transforming his health. He lost 100 pounds after struggling with weight issues since childhood. Takeout meals were replaced with home-cooked chicken, vegetables, and rice.
Unable to afford name-brand Ozempic, Enderle turned to Hims & Hers, paying $2,100 for a year’s supply of compounded semaglutide. He says the medication has liberated him from a “prison.” Now, he faces uncertainty as access to the cheaper compounded drugs vanishes.
Navigating the Shifting Landscape
Some patients may switch to generic liraglutide or explore overseas sourcing. Others may risk mixing their own medications from unregulated sources. Experts warn against this.
Hims & Hers is offering “personalized doses” of compounded semaglutide, but this approach faces legal challenges. The Outsourcing Facilities Association (OFA) has sued the FDA, contesting its authority.
The Future of GLP-1s
The FDA’s crackdown benefits major drug companies, with telehealth services partnering with them to maintain supply. Ro offers Zepbound through Eli Lilly’s LillyDirect, while Noom partners with Gifthealth for single-dose vials.
Generic versions and biosimilars are gaining traction, potentially lowering costs and increasing access. As of May 2024, the FDA had already approved two biosimilars for Humira, a popular drug used to treat autoimmune diseases, which are expected to be significantly cheaper than the brand-name version (FDA).
Despite discounts from Eli Lilly and Novo Nordisk, name-brand drugs remain expensive. Counterfeit Ozempic is also a growing concern.
Protecting Yourself
Proceed with caution when using telehealth services. Ensure access to licensed practitioners and be honest about your health information. Verify the source of compounded drugs, seeking transparency and labeled medications.
“Avoid any telehealth company falsely claiming that compounded drugs have been approved by the FDA.”
Eli Lilly has sued telehealth companies like Fella Health and Henry Meds for selling unapproved tirzepatide. Novo Nordisk ended its partnership with Hims & Hers, citing “deceptive marketing.”
Dr. Jyotsna Ghosh anticipates ongoing legal battles between pharmaceutical companies and compounding pharmacies. She believes that new medications like Eli Lilly’s oral orforglipron could revolutionize the market.
Ultimately, the demand for effective and affordable weight-loss medications will continue to drive innovation and shape the future of this dynamic industry.
