The U.S. Food and Drug Administration (FDA) announced on December 19th, 2024, that the shortage of tirzepatide, the active ingredient in the weight loss drug Zepbound and the diabetes medication Mounjaro, has been resolved. This ends a two-year period of limited availability for the medication. The FDA confirmed it will continue monitoring the supply and demand for these products.
The shortage led to specialty and compounding pharmacies being authorized to sell off-brand versions of tirzepatide. These alternatives were often obtained through telehealth prescriptions and offered at lower costs compared to traditional insurance-covered prescriptions. Name-brand tirzepatide weight loss drugs typically cost around $1,000 per month without insurance, while off-brand options ranged from $250 to $350. With the shortage now officially over, these pharmacies are required to cease selling their unapproved versions of the drug.
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A Zepbound injection pen, the medication used for weight loss that was recently in short supply.
Eli Lilly, the manufacturer of Zepbound, released a statement acknowledging the efforts of their manufacturing and quality teams in expanding production capacity to address the shortage. The company emphasized the importance of patients accessing safe and effective medication.
The FDA also addressed concerns regarding overdoses associated with off-brand tirzepatide products. Reports indicated instances of patients self-administering incorrect doses or healthcare professionals miscalculating dosages. These errors were sometimes attributed to variations in formulas between off-brand and name-brand drugs. Compounded drugs lack FDA approval, meaning their safety, effectiveness, and quality are not verified by the agency.
This recent shortage is not an isolated incident. The FDA has previously reported shortages of semaglutide, the active ingredient in Wegovy and Ozempic, weight loss and diabetes medications produced by Novo Nordisk.
Eli Lilly and other pharmaceutical companies have been actively combating the distribution of off-brand versions of their weight loss medications. Legal action has been taken against medical spas, compounding pharmacies, and weight loss clinics involved in selling these unauthorized alternatives. Conversely, the Outsourcing Facilities Association, representing compounding pharmacies, filed a lawsuit against the FDA in October, challenging the agency’s decision to remove tirzepatide from the drug shortage list. The association argued that the FDA disregarded evidence indicating a continuing shortage. In response, the FDA temporarily reinstated tirzepatide to the list for reevaluation, allowing compounding pharmacies to continue production.
In an effort to address supply chain challenges and provide more affordable access to Zepbound, Eli Lilly has partnered with telehealth company Ro to offer a half-price version of the drug in vials, as opposed to prefilled pens.
Eli Lilly further urged a complete halt to the marketing and sale of unapproved tirzepatide products, emphasizing the FDA’s role in protecting patients from potentially unsafe and ineffective medications. The company also stressed the importance of transitioning patients from compounded tirzepatide to FDA-approved versions. They commended the FDA and other regulatory bodies for their efforts in safeguarding patients from the risks associated with counterfeit and compounded medications.
