A Major GLP-1 Drug Shortage Is Over. Some Patients Aren’t Celebrating

Mounjaro and Zepbound are now out of shortage. This should be good news—but because so many patients are taking compounded versions of these GLP-1 medications, it’s a complicated situation.

To revisit this article, visit My Profile, then View saved stories. Last week, the US Food and Drug Administration announced that tirzepatide is no longer in shortage. It has been a long time coming: The active ingredient in the weight-loss drug Zepbound and diabetes medication Mounjaro has experienced runaway popularity, along with other GLP-1 meds like Ozempic. This unprecedented demand sent it into shortage in December 2022. The end of drug shortages are usually a good thing—but for many people currently taking tirzepatide, this is a moment of fear and uncertainty rather than celebration. For them, this means the meds they are accustomed to taking may be harder to get. “Absolutely devastating,” says Tennessee-based Gianna Green, who has taken the drug for only a short time but calls its effects “completely life-changing.” Green belongs to a group of likely millions of people who have been taking a “compounded” version of tirzepatide. In the US, when drugs are in shortage, pharmacies can produce custom copies. Unlike generic drugs, which are FDA-approved products brought to market after patents expire, compounded meds are meant to be substitutes offered for specific purposes, like drug shortages. As such, they have not historically been mass-produced, and they are not subject to the same approval processes as standard pharmaceutical drugs. But the sky-high demand for GLP-1 meds has created a booming market for compounded tirzepatide and semaglutide, especially since telehealth companies sell these meds for a fraction of the price of their name-brand counterparts. The telehealth startup Ro, for example, offered an introductory month of tirzepatide for weight loss for $99; name-brand Zepbound, meanwhile, can cost over $1,000 without insurance. (Some companies also allow payment via Klarna and other “buy now, pay later” services for their compounded products, lowering financial barriers even further.) Many of the telehealth companies ship the drugs after a quick questionnaire, with no lab work or doctor visit required, which means new patients can get meds within days. Now, though, compounded tirzepatide patients are in a precarious position. Many are in the dark about whether they can refill their prescriptions or how long they have until they need to make alternative medication plans, and they fear a future where they cannot access the drug. “I mean this without any shred of embellishment, tirzepatide gave me my life back,” Jim Bertel says. A 40-year-old who says he has lost 72 pounds on the medication, Bertel has used a variety of telehealth providers to get the compounded version of the drug, bouncing around based on cost. He feels “deeply uneasy” about the shortage ending. There are two types of pharmacies permitted to compound drugs, known as 503a and 503b pharmacies. With the shortage ended, 503a pharmacies need to cease nearly all production of copies immediately; 503b pharmacies, which typically make larger quantities, have a 60-day off-ramp period. Most of the pharmacies compounding these meds are 503a—which means that the supply is already slowing, and in some cases lurching to an abrupt halt, for a large number of people who have come to rely on this medication. “It would make sense that people would panic over a shortage,” says Maria Rising, a compounded tirzepatide patient who also runs a popular Instagram channel about the medication. “But they’re actually panicking because the shortage is over.” “A lot of these patients have now been left flat-footed. They’ve got a prescription for a compounded drug that can’t be filled anymore,” says Alliance for Pharmacy Compounding CEO Scott Brunner. “I don’t think the way the FDA has done this has been productive.” The APC, which represents over 600 compounding pharmacies in the US, has sent a letter to the FDA urging it to use enforcement discretion and allow compounders an extended off-ramp to help transition patients. The FDA has expressed willingness to provide “regulatory flexibility” toward compounders that keep filling requests that were made prior to the shortage ending. “The FDA recognizes that there may be circumstances where an outsourcing facility may not be able to predict when a drug shortage will be resolved, and the facility may have orders for a compounded drug in-house that were in progress when the drug was removed from FDA’s drug-shortage list,” says FDA press officer Amanda M. Hils. But, according to Hils, the regulator may take action against facilities that fill new orders, as well as facilities filling old orders after a 60-day grace period. One of the most popular compounded tirzepatide suppliers for telehealth companies, Hallandale, ceased production to stay in compliance with the law. (“Unlike others who may have taken a different stance,” it noted in a letter to patients and prescribers.) It has canceled all orders in progress and recommended that patients switch to compounded semaglutide if they are able. It also encouraged patients to complain to the FDA about how difficult the situation is, including a link out to leave the regulators a comment. For now, many patients and providers remain on unsteady ground. Some telehealth providers, like Henry Meds, are still advertising and selling compounded tirzepatide. Some are offering only tirzepatide with additives like glycine, niacinamide, and B vitamins, and in doses that are different than those offered by Eli Lilly’s products—since these formulations are different from direct copies, they may try to argue that it is still legally viable to compound them. That may not stop lawsuits, though. “Lilly is exploring all options to help address the patient safety risks posed by counterfeit, fake, and illegal compounded tirzepatide,” says Eli Lilly spokesperson Antoinette Forbes, who also says that Lilly calls upon regulators to take action against “illegal knockoffs.” Others have already stopped sales, like Eden, which has created a special landing page declaring compounded tirzepatide to be “banned nationwide!” Ro, one of the most prominent telehealth companies in the space, has also stopped offering the product. “We are working to ensure our patients have the best options available to them to preserve continuity of care. We’ll follow the FDA’s guidance on compounding and all applicable laws and regulations,” says Ro spokesperson Nicholas Samonas. The company is still selling compounded semaglutide, as well as Zepbound and Wegovy. (It still lists Zepbound’s supply as “inconsistent” and Wegovy as in “shortage.”) Other providers are explicitly telling patients to stock up on the medications. Telehealth clinic Emerge, for example, sent an email to patients noting that it was planning to offer longer-term prescriptions. “If the situation and pharmacy permits, we’ll offer the option to place orders for many months of tirzepatide,” it says. In the longer term, though, it notes that patients may need to switch to compounded semaglutide. Meanwhile, a drug compounding industry group called the Outsourcing Facilities Association filed a lawsuit against the FDA on October 7, claiming that the drug remains in short supply. When asked whether Eli Lilly is confident it has supply to accommodate compounded tirzepatide patients switching over to its products, Forbes sent the following statement via email: “All doses of Mounjaro and Zepbound—Lilly’s FDA-approved tirzepatide medications—have been available since early August. The FDA has confirmed that the shortage of Mounjaro and Zepbound is “Resolved” as communicated on FDA’s website.” Whether or not it’s readily available, some patients believe price will continue to present an obstacle. This August, Eli Lilly announced that it would begin selling more affordable versions of Zepbound, with a month’s supply running between $400 and $550 depending on the dosage. Despite the introduction of this product, many people who have been taking compounded tirzepatide say they won’t be able to afford the name-brand version, even if it is readily available. “It is simply financially inaccessible,” Bertel says. The FDA does not recommend taking compounded versions of GLP-1 medications and has advised potential patients about its concerns over dosing errors and adverse effects related to compounded semaglutide and tirzepatide. A variety of anti-obesity organizations have also warned against taking compounded GLP-1 meds, citing the lack of regulatory oversight. There are warranted concerns about whether bad actors within the compounding industry have put out inferior or unsafe products, and the industry certainly deserves careful scrutiny. But with so many people already taking compounded versions of these medications—and with such great reported success in many cases—this muddled and abrupt cessation has provoked its own health care crisis. “I’m not worried, I’m terrified,” says 71-year-old Ann Rezarch, who takes compounded tirzepatide for lipedema and says she cannot afford the name-brand meds. She calls revoking access now “inhumane.” What’s more, with many compounded tirzepatide patients likely to shift to taking compounded semaglutide, it’s a crisis that may only get more intense when semaglutide, too, is removed from the FDA shortage list. (It is unclear when that will happen, but there is evidence it may not be far off: Novo Nordisk, which makes Wegovy and Ozempic using semaglutide, has recently increased supply of most dosages of the meds in the US.) The cost of drugs does not factor into whether they are in official shortage or not, but the affordability of these medications is directly connected to how accessible many patients find them. Without pushes to lower barriers further, the removal of compounded options from the market could lead to a rush toward counterfeit GLP-1s or research peptides. “It’s not acceptable to me that this is just going to stop,” says Rezarch. “This sounds corny, but it gave me hope.” More From WIRED Reviews and Guides © 2024 Condé Nast. 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