January 10, 2025
Lilly intervenes in OFA lawsuit against FDA
This past week the US District Court for the Northern District of Texas approved Eli Lilly’s request to intervene as an additional plaintiff in OFA v. Califf. You remember OFA v. Califf, right? That’s the case where the Outsourcing Facilities Association contended that the FDA was capricious in ending the tirzepatide shortage because it relied on incomplete information to make that decision (i.e., it took Lilly’s word at face value) rather than going through notice and comment rulemaking.
One claim Lilly makes in its intervention is concerning: The drug maker says FDA lacks statutory authority to determine circumstances under which 503A compounding pharmacies can prepare copies of FDA-approved drugs regularly or in inordinate amounts. Yes, you read that right — Lilly says the FDA isn’t allowed to decide when compounders can compound FDA-approved drugs.
Sure, the statute plainly contradicts that claim, but it doesn’t mean the court won’t take it seriously. Of course APC is concerned about such a broad — and, frankly, disturbing contention. We’ve released a statement to that effect, and we’re considering the best legal options. Stay tuned.
