In an order filed Tuesday afternoon, Judge Mark Pittman denied the Outsourcing Facilities Association’s request for an injunction pending appeal. The decision keeps compounded tirzepatide off the market and confirms that the case will continue in the Northern District of Texas, even as OFA seeks relief from the Fifth Circuit.
The ruling was direct and, at times, sharp. The judge accused OFA of trying to alter the court’s roadmap after receiving an unfavorable preliminary injunction ruling earlier this month. He reminded both sides that the structure of the case had been clearly established and would proceed to summary judgment as scheduled.
In a subtle but telling flourish, the judge opened his order with a quote from General George S. Patton: “If everyone is thinking alike, then somebody isn't thinking.” While not a legal argument, the reference may offer a glimpse into how the court views OFA’s request. Although OFA, the FDA, and Eli Lilly had all agreed to convert the earlier ruling into a final judgment in order to expedite an appeal, Pittman rejected the idea that consensus should dictate how the court operates. The quote suggests a preference for judicial independence and a reluctance to rubber-stamp a path laid out by the parties themselves.
Earlier in the day, before the court issued its order, On The Pen spoke exclusively with OFA Chairman Lee Rosebush. In the interview, he maintained that the goal of converting the earlier ruling into a final judgment was to streamline the appeals process. “It’s ironic,” Rosebush said. “We did not even get an oral hearing on the preliminary injunction, but now we are getting one for summary judgment.”
He also pointed to what OFA views as broader consequences. According to the group’s filings, nearly 80 million doses of compounded semaglutide were administered over the past year, contributing to substantial savings in the healthcare system. Rosebush warned that the case is no longer just about GLP-1 medications. He argued that pressure from Lilly and Novo has led to an FDA enforcement posture that eliminates some of the most carefully regulated non-branded options available to patients. “It is being sold as a safety issue,” he said, “but by removing 503B access, they are leaving patients with fewer safe and federally regulated alternatives.”
The court’s decision means 503B compounded tirzepatide will remain off the market for the foreseeable future. The case is now unfolding on two fronts, one in Pittman’s courtroom and one in the appellate court. Meanwhile, OFA continues to encourage patients and providers to submit evidence of ongoing access issues through its website at 503bs.org
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