Millions of Americans Face Sticker Shock From Weight Loss Drugs as FDA Bars Production of Cheaper Versions of Ozempic, Others

The huge popularity and overwhelming demand for brand-name GLP-1 weight loss drugs resulted in a drug shortage in 2022, forcing the Food and Drug Administration to put drugs like semaglutides (Ozempic and Wegovy) and tirzepatides (Mounjaro and Zepbound) on the FDA drug shortage list. Doing so allowed so-called compounding pharmacies like Olympia Pharmaceuticals in Orlando, Florida, to meet patient demand by offering vastly more affordable versions of the expensive drugs, which many health insurers won’t cover for garden variety weight loss. But by 2025, the FDA announced the shortages for both semaglutide and tirzepatides had been resolved. Two lawsuits filed by the Outsourcing Facilities Association, or OFA, a trade association that represents the compounding pharmacies, , disputing the FDA’s decision, failed. The deadline for these compounding pharmacies – also known as 503Bs – to cease production of compounded GLP-1s was May 22. “We stopped producing it yesterday (Thursday). We’re in 100 percent compliance,” Olympia Pharmaceuticals CEO Mark Mikhael told the Sun. “It truly is off the shortage list, and the 503-Bs did what they were supposed to do.” Now, patients who grew accustomed to spending between $129 and $497 out of pocket per month are now faced with the sticker shock of paying full price for brand-name GLP-1s, which can cost more than $1,000 per month. Insurance companies typically won’t cover the brand-name drugs unless a patient has a Body Mass Index, or BMI, of 30 (the official threshold for obese) or higher. Some insurance companies require an even higher BMI threshold. “I don’t think we’ve heard the maximum public outcry,” Mr. Mikhael told the Sun. That will likely happen in the next two to three months, when customers like Olympia’s run out of the 90-day refills of compounded GLP-1s. Earlier this year, Novo Nordisk, the maker of Wegovy, struck deals with telehealth firms like Hims & Hers and LifeMD to sell the drug for $499 per month. “These arrangements still restrict supply, keep prices high, and lock patients into branded, name-only prescriptions with zero flexibility,” said Brigham Buhler, owner of Ways2Well, a Houston-based biotech firm. On Reddit, GLP-1 users asked for advice on what to do now that compounded GLP-1s have stopped and their insurance companies won’t cover brand-name drugs.“$500 a month prices from Eli Lilly and Novo without insurance are ridiculous. Americans are struggling already and that is not affordable. It’s insulting and infuriating,” wrote one user on an Ozempic subreddit. Some compounding pharmacies and telehealth firms are sidestepping the FDA by offering bespoke copies of tirzepatide and semaglutide by incorporating additives like vitamin B12 into the drug, making it different enough that is can be compounded legally. According to the Federal Food, Drug, and Cosmetic Act (FDCA), a compounding pharmacy can produce a version of the drug if “there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.”Eli Lilly and Novo Nordisk have sued telehealth companies like Mochi Health and Clover Meds for allegedly selling altered versions of compounded GLP-1s that have been mass-produced, despite being falsely marketed as a personalized treatment. “If you’re making a batch of 100,000 of these (compounded GLP-1s), is it customizable medicine?” Mr. Mikhael asked.Mr. Mikhael, who uses GLP-1s, has lost 60 pounds and seen both his blood pressure and cholesterol levels dramatically improve. Instead of taking three pills daily to treat his health conditions, he now takes a once-a-week GLP-1 shot and has done away with the pills. One in eight people have taken a GLP-1 agonist, and 6 percent are currently taking the drug, according to a 2024 KFF report.“The way I look at that is, that’s one in eight voters. So, how is the administration going to respond to that?” Mr. Mikhael said.Health and Human Services Secretary Robert F. Kennedy Jr., who was once critical of GLP-1s but has since acknowledged them as ” miracle drugs,” highlighted childhood obesity in his recent Make America Healthy Again, or MAHA, report on childhood chronic disease.“Obesity is a chronic disease. It’s a health crisis that faces America, and all the comorbidities that are associated with it. I think (GLP-1s) are a solution for this,” he said.

Millions of Americans Face Sticker Shock From Weight Loss Drugs as FDA Bars Production of Cheaper Versions of Ozempic, Others

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