For Maria Rising, managing her health felt like chasing a phantom. The 30-year-old Lansing, Mich. consultant has for years battled polycystic ovary syndrome (PCOS) — a hormonal disorder that can cause weight fluctuations, insulin resistance, and in some cases debilitating pain.
“It’s like hitting a moving target,” Rising said, describing the endless treatments that never quite worked. Then came a glimmer of hope: In January 2024, her gynecologist suggested Zepbound (LLY), one of the GLP-1 medications proving remarkably effective at treating a host of conditions, including managing PCOS symptoms.
The drugs worked so well they’d become victims of their own success — Rising found herself at the back of a very long line.
“I was calling pharmacies. I was calling all over the state. I was like, ‘I’ll drive and go get it if you have it.’ But nobody had it,” she said.
When Rising couldn’t find Zepbound at any pharmacy, she explored alternatives, in consultation with her doctors, and eventually turned to compounded tirzepatide — an off-brand version of the active ingredient in Zepbound. Rising currently pays $287 a month for her compounded medication, a steep discount compared to the branded drug’s nearly $1,000 price tag. Since being on the drug, she has lost 40 pounds and other symptoms have eased.
But that might all change very soon. The U.S. Food and Drug Administration (FDA) recently announced the end of shortages that have plagued popular weight-loss drugs, like Zepbound and Novo Nordisk’s (NVO) Wegovy. With branded options now deemed “fully available,” the agency plans to crack down on compounded GLP-1 medications as soon as this month — a regulatory pivot that could reshape access for patients like Rising overnight.
Soaring demand for weight-loss drugs has turned Novo Nordisk and Eli Lilly into the world’s most valuable pharma companies. At the same time, shortages have created a lucrative market for compounders and telehealth companies. But for patients, the situation is far less fortunate. These changes could cut off access to affordable alternatives for thousands of people, including Rising.
“There’s a lot of folks really panicked right now about it. I don’t want to go back to having crazy pain every day from PCOS either,” Rising said.
Rising now has few options. She could switch to an expensive branded medication or — what she intends to do — continue her treatment with a customized, clinically necessary compounded version of tirzepatide that meets stricter regulatory standards. But that path is more uncertain.
Recent FDA decisions are reshaping the market for compounded (or off-brand) versions of GLP-1 drugs, which have served as a workaround during supply shortages. The move has also intensified a battle between Big Pharma and compounding pharmacies over control of GLP-1 sales in the U.S.
Compounding involves modifying FDA-approved drugs to meet individual patient needs, such as adjusting dosages, changing administration methods, or removing allergens — the kind of customization Rising is now relying on to access tirzepatide. Typically, the FDA prohibits compounding drugs that are exact copies of commercially available medications. However, when a drug is in shortage, these types of compounded versions are allowed.
This regulatory loophole has proved lucrative for compounding pharmacies. Olympia Pharmaceuticals, which entered the GLP-1 market just 18 months ago, has seen demand surge by 15-20%. The company’s CFO, Joshua Fritzler, said in a February media roundtable that Olympia’s phones now ring constantly with doctors and patients “panicking” about where they’ll obtain medication when the FDA’s new restrictions take effect.
Olympia is a member of the Outsourcing Facilities Association (OFA) trade group that sued the FDA twice over the removal of tirzepatide and then semaglutide (Ozempic’s active ingredient) from its shortage list. The group argued that the shortages persist and that the FDA’s decision will harm patients by limiting access to affordable alternatives.
A judge recently sided with the FDA in the tirzepatide case and the agency has issued a clarification on its policies regarding compounded GLP-1s.
The FDA will begin enforcing rules against outsourcing facilities making compounded tirzepatide on March 19. Smaller pharmacies (503A’s) are already past their deadline. For compounded semaglutide, 503A pharmacies have until April 22 and 503B facilities have until May 22 — or until there is a court decision in the semaglutide case, whichever date comes later.
Novo Nordisk, the maker of Ozempic and Wegovy, and Eli Lilly have both contended that compounded versions of their medications are unsafe.
“No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients,” Novo Nordisk said in a statement when the FDA declared the end of the semaglutide shortage.
Eli Lilly made a similar statement: “FDA was also clear that compounders must immediately begin transitioning patients taking compounded tirzepatide knockoffs to FDA-approved tirzepatide medicines.”
However, both companies have a big financial interest in limiting the sales of compounded GLP-1s.
Eli Lilly’s stock price has climbed more than 50% since the FDA approved Zepbound in November 2023, pushing its market cap above $800 billion. Novo Nordisk has similarly seen its stock rise 86% since Wegovy launched in 2021.
Novo Nordisk’s U.S. executive vice president, David Moore, recently told investors in February that compounded drugs were cutting into the company’s sales more rapidly than expected.
Meanwhile, some compounders have also made a killing with GLP-1s. The millennial-targeted telehealth company Hims & Hers started offering compounded semaglutide last May. The company’s total sales grew 69% last year to $1.5 billion.
“Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs,” Hims CEO Andrew Dudum wrote in a post on X in February. “We’re also closely monitoring potential future shortages.”
Fritzler said GLP-1 medications make up about half of Olympia’s business by volume, with the company producing tens of thousands of vials each week. Despite this, he emphasized that Olympia will comply with regulations and will not attempt to circumvent the law by creating customized compounded GLP-1s.
Fritzler told Quartz that he expects that most patients will transition to branded medications, while others might switch to liraglutide — an older and less effective GLP-1 drug that requires daily injections rather than the weekly regimen of newer medications.
For others, the cost and inconvenience has become too overwhelming.
Michelle Pierce, 25, is a patient from Austin who also has relied on a compounded semaglutide to treat her PCOS.
She first tried metformin, a common type 2 diabetes medication, but it wasn’t effective for her. Her doctor then recommended a GLP-1 drug, but getting insurance coverage was a challenge, requiring an extensive pre-authorization process and two appeals. Even after approval, the $600 monthly cost for Ozempic was too high, so her doctor suggested compounded semaglutide as a more affordable alternative.
Now, however, she fears she won’t be able to afford treatment moving forward. Instead, she plans to taper off the medication over the next few months, despite concerns that stopping it could affect her insulin levels and carries the risk of regaining weight.
“I have great insurance — private Aetna (CVS) insurance — and I still can’t get a medication that has changed my life,” Pierce said.
The post The weight loss drug shortage is over — and some patients are ‘panicking’ appeared first on Quartz.
