The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs.
The decision, disclosed in a court filing, marked a stark reversal. Just last week the agency said the years-long shortage of the blockbuster drug had come to an end. Under agency guidelines, the FDA warned at the time, compounding pharmacies would no longer be permitted to manufacture and dispense copies of the drugs.
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 that represents FDA-registered compounding pharmacies known as 503Bs, filed a lawsuit against the agency on Monday in Texas, claiming the drug was still in short supply, and that agency’s decision was “reckless and arbitrary.” It sought a temporary restraining order for 14 days that would prevent the FDA from taking action against any compounder that continues making copies of the drug.
