A trade group for large compounding pharmacies sued the FDA over its move to take Eli Lilly’s blockbuster GLP-1 drug off its shortage list, hamstringing compounders’ ability to create their own, cheaper versions.
In a complaint filed Monday in federal court, the Outsourcing Facilities Association, which represents a type of compounding pharmacy known as a 503B, said the FDA’s “reckless and arbitrary decision” to remove tirzepatide from the shortage list last week ignores evidence that the drugs remain in short supply, deprives patients of their treatments and raises drug prices.
The decision violates the law because it occurred without notice or allowing for public comment, and failed to consider all relevant data, the group argued.
“FDA skipped past every single requirement of reasoned rulemaking when it threw up a notice on its website removing Tirzepatide from the shortage list — thereby depriving patients of access to the compounded drug,” the complaint states.
An FDA spokesperson said the agency doesn’t comment on ongoing litigation.
While FDA-approved, brand-name versions of tirzepatide, including Lilly’s diabetes drug Mounjaro and weight loss drug Zepbound, were in shortage for much of the last two years, compounding pharmacies were allowed to make alternatives of the drugs, which aren’t tested or approved by regulators and are sold at sharply lower prices.
But the end of the official shortage means that compounding pharmacies will have to stop making copies of tirzepatide, either immediately or within a couple of months, depending on the type of pharmacy. Pharmacies, telehealth companies prescribing the drugs, and patients have been scrambling to understand how they’ll be affected by the FDA’s move.
In the complaint, the Outsourcing Facilities Association said the removal of tirzepatide from the shortage list prevents 503B outsourcing facilities from capitalizing on significant investments they made to support making the drug.
The group said that the FDA’s failure to follow the Administrative Procedure Act’s requirement for public notice-and-comment rulemaking prevented stakeholders from providing information about tirzepatide’s availability, and deprived them of a reasonable explanation for the drug’s delisting. Removing the drug from the shortages list qualifies as an agency rule, subject to the APA requirement, because it “has the force and effect of the law,” the group argued in the complaint.
The complaint asks the court to vacate the FDA’s decision.
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