On May 1, 2023, the NAM filed a coalition brief urging the 5th Circuit to reverse a Northern District of Texas decision disregarding the regulatory framework Congress established for FDA drug approval and preliminarily enjoining the FDA’s 23-year-old approval of the drug mifepristone. The plaintiffs in this case are a group of medical organizations and doctors who challenged the FDA’s approval of mifepristone under the Administrative Procedure Act, arguing that the drug is unsafe and that it was approved under an improper regulatory pathway. The district court granted the plaintiffs’ request for a preliminary injunction, concluding that they are likely to prevail on the merits of their claims. In finding that the FDA’s actions were arbitrary and capricious, the district court second-guessed the FDA’s scientific judgments.
We argue in our amicus brief that stakeholders in the biopharmaceutical industry rely upon the stability of FDA’s rigorous drug assessment and approval framework to develop and market medical innovations. The district court’s decision undermines Congress’s carefully calibrated regulatory framework for the FDA and risks billions of dollars in investments by: (1) replacing FDA’s scientific judgements with its own view on what information should be considered and how it should be assessed during the drug approval process; and (2) creating the possibility that any healthcare provider could bring suit to challenge any drug approval at any time without the holder of a drug application being given the notice and a hearing Congress required as part of any suspension or withdrawal of an FDA drug approval.
The 5th Circuit vacated the aspect of the district court's decision staying the FDA's 2000 approval of mifeprestone, concluding that the plaintiffs' claim challenging that approval is likely barred by the statute of limitations. The 5th Circuit also vacated the district court's decision staying the FDA's 2019 approval of the generic version of mifeprestone because the plaintiffs failed to show that they were injured by that agency action. The 5th Circuit, however, affirmed the aspects of the district court's decision staying the FDA's 2016 amendments to mifeprestone's risk evaluation and mitigation strategy and the FDA's 2021 decision not to enforce the in-person dispensing requirement for mifeprestone.