The Food and Drug Administration (FDA) announced on Friday that it would reconsider its decision to remove Eli Lilly’s tirzepatide from its shortage list. Tirzepatide is sold as Mounjaro for diabetes and Zepbound for obesity. Just last week, the agency declared that the years-long shortage of the blockbuster drug had ended.
Under agency guidelines at the time, compounding pharmacies would no longer be permitted to manufacture and dispense copies of the drugs. The decision, disclosed in a court filing, marked a stark reversal. Many compounders, telehealth companies, and patients quickly objected to the FDA’s removal of tirzepatide from the shortage list.
The Outsourcing Facilities Association, a group representing FDA-registered compounding pharmacies known as 503Bs, filed a lawsuit against the agency on Monday in Texas. The association claimed the drug was still in short supply and described the agency’s decision as “reckless and arbitrary.” It sought a temporary restraining order for 14 days to prevent the FDA from taking action against any compounder that continues making copies of the drug. In the meantime, the FDA’s reconsideration may pacify some of the concerns voiced by patients and providers reliant on the medication.
The situation remains fluid as more developments emerge regarding tirzepatide’s availability and the FDA’s regulatory stance. Eli Lilly has initiated a sweeping legal offensive against hundreds of compounding pharmacies, telehealth companies, and medical spas producing and selling “compounded” versions of tirzepatide. This aggressive move signifies a new phase in the battle over GLP-1 medications.
Tirzepatide was on the US Food and Drug Administration’s shortage list from December 2022 until October 2, 2024. When drugs in the US face shortages, pharmacists, doctors, and licensed outsourcing facilities are allowed to “compound” copies to ensure patients have access to necessary medicine. The shortage of tirzepatide and semaglutide (the active ingredient in Ozempic and Wegovy) created a substantial market opportunity, with telehealth clinics stepping in to sell these compounded products online at a fraction of the price of their name-brand counterparts.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, estimates that the number of patients taking compounded GLP-1 medications is in the millions. Eli Lilly had previously filed several lawsuits against sellers for deceptive advertising, promoting “generic tirzepatide” or “generic Mounjaro,” and falsely referring to their compounded products as “FDA-approved.” The recent cease-and-desist letters represent a significant escalation in Lilly’s campaign against what it perceives as unauthorized knockoffs. The end of the tirzepatide shortage has created a complicated situation for many patients.
While Eli Lilly introduced cheaper versions of Mounjaro and Zepbound, the prices—ranging from $400 to $550 per month, depending on dosage—are still higher than many compounded alternatives. Some pharmacists report difficulties in obtaining name-brand tirzepatide from wholesalers despite the shortage ending. In response, the compounding GLP-1 industry has launched its own legal actions to continue operations.
The Outsourcing Facilities Association filed a lawsuit in Texas federal court arguing that tirzepatide remains in short supply and that ending the shortage was abrupt and detrimental to patients. Some companies have introduced tirzepatide versions with additional ingredients such as glycine and B vitamins, arguing that these are not direct copies of Eli Lilly’s products and should be permitted. However, Eli Lilly insists that no mass production or marketing of compounded tirzepatide is justified as long as FDA-approved medicines are available.
fda reevaluates tirzepatide access decisions
Novo Nordisk, another major player in the GLP-1 market, has also responded to the compounded medication issue by highlighting a study published in the journal Pharmaceutical Research. The study found that some compounded semaglutide samples had lower quality than claimed and contained impurities, raising safety concerns.
With evidence mounting that GLP-1 medications like tirzepatide could treat conditions beyond obesity and diabetes, including addiction and Parkinson’s disease, demand is expected to grow. The pharmaceutical industry faces the challenge of keeping up with this demand while navigating the legal and ethical complexities involved in compounding practices. Janet McCaskill and her husband, Barry, started using the diabetes drug Mounjaro off-label for weight loss at the end of 2022.
McCaskill said she had tried various diets, including WeightWatchers and keto, but none were sustainable. At 58 years old and weighing about 212 pounds, she feared for her health after losing her brother and both parents to heart disease. Mounjaro, part of a class of drugs known as GLP-1 receptor agonists, includes Ozempic, Wegovy, and Zepbound.
McCaskill credits the drug for saving her life. However, it was initially expensive, costing about $500 a month, even with a coupon from the manufacturer, Eli Lilly. When the coupon program ended in the summer of 2023, her health-care provider suggested compounded tirzepatide, a lower-cost, non-FDA-approved version available through a local pharmacy for less than $250 a month.
McCaskill continued to benefit from compounded tirzepatide but is now worried about access to her medication. The US Food and Drug Administration (FDA) recently removed tirzepatide from its list of drugs in shortage, which means compounding pharmacies can no longer legally produce the medication unless for specific alterations not regularly done or inordinate amounts. In a year, McCaskill lost nearly 100 pounds, reducing her weight to about 117 pounds.
Her health metrics, including blood pressure, A1C, and triglycerides, improved significantly. The risk of losing access to tirzepatide has thrown her into a panic, as she fears losing the progress she has made. McCaskill’s husband also started using the compounded tirzepatide, and now both worry about future access.
The FDA’s decision has affected many people who relied on compounded drugs for affordability. Approximately 20% of all prescriptions for these drugs are estimated to be for compounded versions. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, estimated that millions could be using compounded versions, with many struggling to switch to FDA-approved drugs due to cost.
The organization requested the FDA provide a 60-day buffer before compounding must stop to ensure continuity of patient care. The end of the tirzepatide shortage signals improved availability of branded drugs like Mounjaro and Zepbound, but localized supply disruptions continue. The FDA has not discussed interactions regarding the requested buffer period for continuity.
As drug manufacturers ramp up production, patients like McCaskill are left uncertain about their future access to essential medications that have significantly impacted their health and lives.
