The move is a significant victory for the compounding pharmacies that sued FDA over what they said was the agency’s sudden decision to remove tirzepatide from the agency’s official drug shortage list earlier this month.
Tirzepatide is sold as Mounjaro for diabetes and Zepbound for obesity.
In a court filing late Friday, the FDA said it would reconsider its Oct. 2 decision to remove the drug from the shortage list and wouldn’t pursue regulatory action against the plaintiff compounding pharmacies for making copies of it while the process is underway.
During drug shortages, it is legal for compounding pharmacies to make versions of a branded drug that are essentially the same, but drugmakers argue the practice isn’t safe.
Major demand for anti-obesity drugs has fueled unprecedented demand, and the compounded versions of the drugs have allowed companies not normally in the drug business to start selling their own, much cheaper versions to fill the gap.
The lawsuit by compounding pharmacies and a trade organization representing compounding pharmacies argued the FDA was taking away that access. In the lawsuit, the Outsourcing Facilities Association claimed that the drug is still in short supply and should therefore remain on the shortage list.
Tirzepatide had been in shortage for nearly two years. Lilly has taken steps to ramp up production, and the company said all doses of Mounjaro and Zepbound are available.
A spokesperson reiterated the industry’s view that compounded versions are risky for patients.
However, the company acknowledged that patients’ experiences looking for a particular dose of medicine in their local pharmacies may vary, and specific pharmacies may not necessarily have a particular dose of the medicine in stock.
