January 17, 2025
OFA v. Califf: The latest
If you missed our email earlier this week, here’s an update for you on the Outsourcing Facilities Association/Farmakeio lawsuit against FDA related to the resolution of the tirzepatide injection shortage.
In a hearing Tuesday, Judge Mark Pittman declined to issue a summary judgment in the case, meaning it will continue.
Instead, Pittman instructed the FDA to submit — to both the court and the plaintiffs (OFA and Farmakeio) — the data it relied on when it determined the tirzepatide injection shortage was resolved (the “Decision Memorandum”), and issued a protective order to keep those data confidential.
In layman’s terms, all this means that litigation will proceed. After the FDA provides that Decision Memorandum, OFA et al. will again file a motion for a preliminary injunction, elaborating on their claims in the suit. Then the FDA (and now Lilly, which was approved as an intervening party last week) will have three weeks to file their responses to the OFA claims.
Once all this paperwork has been filed — within about a month — the court will decide whether to grant OFA that preliminary injunction. After that, the judge said, if either party wants to file for a summary judgment, he wants that done “on an expedited basis.”
In short, none of this is surprising. (What would have been surprising is if the judge had granted summary judgment.) Tuesday’s hearing was about process, not the validity of any claims.
APC has written to the FDA to urge that the agency continue to exercise enforcement discretion with pharmacies and outsourcing facilities for continuing to dispense copies of tirzepatide injection while this litigation plays out. We’ll share FDA’s reply if it provides one. In the meantime, here’s our statement from last week about Eli Lilly’s intervention in the case.
