If you missed our email earlier this week, here\u2019s an update for you on the Outsourcing Facilities Association\/Farmakeio lawsuit against FDA related to the resolution of the tirzepatide injection shortage.<\/p>\n
In a hearing Tuesday, Judge Mark Pittman declined to issue a summary judgment in the case, meaning it will continue.<\/p>\n
Instead, Pittman instructed the FDA to submit \u2014 to both the court and the plaintiffs (OFA and Farmakeio) \u2014 the data it relied on when it determined the tirzepatide injection shortage was resolved (the \u201cDecision Memorandum\u201d), and issued a protective order to keep those data confidential.<\/p>\n
In layman\u2019s 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.<\/p>\n
Once all this paperwork has been filed \u2014 within about a month \u2014 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 \u201con an expedited basis.\u201d<\/p>\n
In short, none of this is surprising. (What would<\/em> have been surprising is if the judge had granted summary judgment.) Tuesday\u2019s hearing was about process, not the validity of any claims.<\/p>\n 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\u2019ll share FDA\u2019s reply if it provides one. In the meantime, here\u2019s our statement from last week<\/a> about Eli Lilly\u2019s intervention in the case.<\/p>\n","protected":false},"excerpt":{"rendered":"