The fate of mifepristone in Texas has broader implications for life sciences companies
A federal district court in Texas will soon issue a ruling of enormous implication for life sciences companies: whether to vacate Food and Drug Administration (FDA) approval of a product over FDA objection. In Alliance for Hippocratic Medicine v. FDA, 2:22-cv-223 (N.D. Tex. Mar. 15, 2023), several medical organizations and doctors ask a court to vacate FDA’s approval of mifepristone. Although the court has not yet issued a decision – and that decision will likely be appealed – the court’s upcoming opinion could impact broader pharmaceutical product liability litigation.
There are three notable shifts in the plaintiffs’ approach to attacking mifepristone which might embolden other plaintiffs to bring more suits challenging FDA’s authority and decisionmaking with respect to other medications: increased used of citizen petitions, enhanced scrutiny of clinical trial protocols, and drastic requests to withdraw medications.
Citizen petitions and standing. Central to the plaintiffs’ current federal court challenge are prior attempts to challenge mifepristone by bringing citizen petitions. Exhausting FDA’s administrative review process via citizen petitions is a necessary but not sufficient prerequisite to bringing suit in federal court; generally, courts have still required some other demonstration of injury-in-fact for organizational plaintiffs to satisfy standing. What the mifepristone hearings suggest, however, are that association plaintiffs might have standing to litigate FDA’s actions by virtue of the time and effort they spent challenging FDA’s approval of mifepristone through prior citizen petitions. If the court accepts plaintiffs’ standing arguments on the basis of plaintiffs’ having filed a citizen petition, that may allow more organization plaintiffs to bring suit in federal courts. That will lead to more associations filing citizen petitions because even if they are unlikely to succeed in front of FDA, those citizen petitions may be more of a gateway to federal court than previously recognized.
There are other standing issues raised by the mifepristone litigation – including when plaintiffs have to bring suit following a citizen petition denial, and what precise FDA actions have to be challenged – and the upcoming opinion will no doubt include takeaways in confronting the standing of future plaintiff organizations emboldened by the mifepristone litigation.
Clinical trial protocols and one-to-one harmony with labels. The plaintiffs advance an argument in the mifepristone litigation about clinical trials that is of particular interest for life sciences companies.
Specifically, the plaintiffs complain that the FDA-approved label for mifepristone did not include the exact conditions and requirements for use as were included in the underlying clinical trials, and that this discrepancy warrants negating FDA’s drug approval. They contend that the study protocols contained “crucial safeguards” that were omitted from the final approved label.
FDA responded that clinical trials often take place before approval, warranting greater protections at that early stage for the medication users/trial participants. Furthermore, as life sciences companies know, clinical trial protocols are not just about testing the safety of the medication but also are designed to protect against bias and confounding in the results. There may be protocol safeguards in place during a trial to ensure the efficacy findings aren’t the result of some other non-drug element. Following this sort of trial protocol to avoid muddled effectiveness indications has no bearing on the safety of the medication; therefore, these protocols are often wholly unnecessary in real world use, which is exactly where the medication and corresponding label is used. Regardless of whether the court ends up ruling that clinical trial conditions must match the label one-to-one, this level of inquiry by a court into clinical trials and FDA’s decision-making about labels may well be a harbinger of future plaintiff litigation strategy.
Court-ordered withdrawal of FDA-approved medication. The plaintiffs seek an extraordinary remedy: an order from the court requiring the withdrawal of a medication from the market over FDA’s objection. As FDA scholars pointed out, such a court action would be unprecedented.
Further, FDA and amicus noted that the statutory framework that gives FDA authority to approve medications it determines to be safe and effective, does not provide for anyone but the HHS Commissioner (who has delegated this authority to the FDA Commissioner and by extension, FDA) to force a withdrawal.
The court has not yet indicated that it would go so far as to force a withdrawal of the medication even if it rules in favor of plaintiffs on other challenges, and there is reason to believe the court will hesitate to take such an unprecedented action. But life sciences companies will face significant litigation risks if the court determines it has the authority to second-guess, and override, FDA’s determination about a medication.
For further information or to ask questions regarding the mifepristone litigation, please contact the authors or your DLA Piper lawyer contact.