The Outsourcing Facilities Association has taken the next step in its lawsuit against the FDA over the agency’s declaring the tirzepatide injection shortage is resolved.
In early January, federal judge Mark Pittman outlined a series of next steps in the case. First, the FDA submitted under seal the data it relied on when it determined the tirzepatide injection shortage was resolved. With those data in hand, the next step was for OFA (and its co-plaintiff, APC member FarmaKeio Custom Compounding) to review it all and then file a motion for a preliminary injunction, elaborating on its claims in the suit.
On Tuesday OFA did just that.
In the motion, OFA argued that, because FDA was making a decision that applied to the entire compounding industry, it was in fact creating a rule rather than making an adjudication. That’s a critical difference when it comes to the law: Rulemaking has much stricter requirements than simply adjudicating.
OFA took FDA to task for not meeting one of the most important of those requirements: engaging the public with a notice-and-comment period. That, it pointed out, was required by the Administrative Procedure Act. In other words, by making such a broad decision — “declar[ing] the law going forward” — FDA was rulemaking, and, ironically, it didn’t follow the rules when doing so.
OFA also argued that FDA’s originally taking tirzepatide off the shortage list (with “scant explanation”) was based entirely on Lilly’s representation of the situation, rather than on reality. Then, even after being presented “information showing surging demand for tirzepatide, inability of its manufacturer to keep up, scarcity in various regions and at the national level, and delays in filling prescriptions,” the agency instead doubled down on its declaration that the tirzepatide shortage was over.
“FDA would prefer to engage only the manufacturers of name-brand drugs in deciding whether shortages exist,” which, it wrote, was “arbitrary in the extreme.”
And that, OFA argued, made clear that declaring the shortage over was an arbitrary and capricious decision. Thus OFA is confident that it has “a substantial likelihood of success on the merits” in the suit, which is required for its motion for an injunction — an injunction that “is required to protect patients and prevent irreparable injury to Plaintiffs.”
The next step in the case will be FDA (and now Lilly, which was approved as an intervening party) filing a response to OFA’s request for an injunction. And both parties, per Judge Pittman, can also request summary judgment in the case.