An Endpoints News story authored by Shelby Livingston titled “Compounders’ motion for preliminary injunction denied in case over tirzepatide shortage” (here; subscription needed) appears to give this round of the fight to declare the tirzepatide drug shortage over to the FDA. The Honorable Mark Pittman, U.S. District Court for the Northern District of Texas, denied a request for a preliminary injunction to keep the FDA from stopping compounders of the weight loss drug tirzepatide from making knockoffs of the innovator product until a final decision on the case is made. Firms must discontinue compounding in accord with the FDA’s previously announced schedule which provides no further compounding by 503B compounders (also known as outsourcing facilities) after March 19, 2025. Compounders governed under section 503A of the Act were to have stopped compounding the drug by February 18, 2025, and thus should have already stopped compounding the drug or they could face immediate enforcement actions. According to the Endpoints story, Judge Pittman wrote “The court finds that plaintiffs have failed to demonstrate a likelihood of success on the merits of their claims.”
The battle between the FDA and compounders of the weight loss drug has been going on for some time as explained in our previous blog posts here, here, here, here, here, and here.
This is round four of the fight and it appears that we may have at least two more rounds until a knockout is in the books. We will keep you updated on whether this compounding story ends in this round or the next, or if the slug fest will continue all the way to the Supreme Court.
