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- The Food and Drug Administration said the active ingredient in Eli Lilly’s weight loss drug Zepbound is no longer in shortage, a decision that will eventually bar compounding pharmacies from making unbranded versions of the injection.
- But the FDA said it will provide a 60 to 90-day transition period where it will not take action against pharmacies for making compounded tirzepatide, which will give patients time to switch to the branded version.
- It’s the latest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in Eli Lilly’s widely prescribed weight loss drug Zepbound and diabetes treatment Mounjaro.
The Food and Drug Administration on Thursday said the active ingredient in Eli Lilly’s weight loss drug Zepbound is no longer in shortage, a decision that will eventually bar compounding pharmacies from making cheaper, unbranded versions of the injection.
“FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, is resolved,” the agency said in a letter. “FDA continues to monitor supply and demand for these products.”
The agency’s decision, based on a comprehensive analysis, marks the end of a period where certain pharmacies could make, distribute or dispense unapproved versions of tirzepatide – the active ingredient in Zepbound – without facing repercussions for violations related to the treatment’s shortage status.
Compounding pharmacies must stop making compounded versions of tirzepatide in the next 60 to 90 days, depending on the type of facility, the agency said. The FDA said that transition period will give patients time to switch to the branded version.
It’s a blow to some compounding pharmacies, which say their copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its hefty price tag of roughly $1,000 a month. Zepbound and other weight loss drugs are not covered by many insurance plans, but Eli Lilly’s diabetes counterpart Mounjaro is.
It’s the latest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Mounjaro. Eli Lilly has invested billions to expand its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand.
A trade organization representing compounding pharmacies — the Outsourcing Facilities Association — sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from its official drug shortages list just days earlier. The group alleges the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists. It also contended that the FDA’s action was a coup for Eli Lilly that came at the expense of patients.
Following the suit, the FDA said it would reevaluate removing tirzepatide from the shortages list. That allowed compounding pharmacies to continue making copycats while the agency reviewed its decision.
Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law.
The Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications when they are available.
However, the FDA does inspect some outsourcing facilities that compound drugs, according to its website.
Source: https://www.cnbc.com/2024/12/19/fda-eli-lilly-weight-loss-drug-zepbound-no-longer-in-shortage.html