Alliance Hippocratic Medicine v. FDA
UNPUBLISHED ORDER (2023)
Rule of Law:
An appellate court may grant a stay pending appeal if the applicant demonstrates a strong likelihood of success on the merits, irreparable injury absent a stay, that other parties will not be substantially injured by the stay, and that the public interest favors a stay, with challenges to agency actions exceeding a six-year limitations period generally time-barred unless an exception applies.
Facts:
- In 2000, the Food and Drug Administration (FDA) approved mifepristone (brand name Mifeprex) under 'Subpart H' regulations, imposing several Risk Evaluation and Mitigation Strategies (REMS) that limited use to 49 days gestation, required three in-person office visits, qualified physician supervision, and reporting of all adverse events.
- In March 2016, the FDA denied a 2002 citizen petition challenging the 2000 approval and, on the same day, approved '2016 Major REMS Changes' that increased the gestational age limit to 70 days, reduced required in-person visits to one, allowed non-doctors to prescribe, and eliminated the requirement to report non-fatal adverse events.
- In April 2019, the FDA approved GenBioPro, Inc.'s abbreviated new drug application (ANDA) for a generic version of mifepristone, which adopted the same labeling and REMS requirements as Danco’s Mifeprex.
- In April 2021, the FDA announced it would 'exercise enforcement discretion' to allow mifepristone to be dispensed through the mail during the COVID-19 pandemic.
- In December 2021, the FDA denied almost all of a 2019 citizen petition (filed in 2019 by plaintiff associations) that challenged the 2016 Major REMS Changes, specifically rejecting the request to keep in-person dispensing and concluding it was 'no longer necessary.'
- In January 2023, the FDA approved a modified REMS for mifepristone, permanently lifting the in-person dispensing requirement.
- The FDA-approved 'Patient Agreement Form' for mifepristone indicates that between 2% and 7% of mifepristone users will experience unsuccessful chemical abortions and require a surgical procedure or emergency care.
- Plaintiff emergency room doctors have treated numerous women for mifepristone complications, including hemorrhage, sepsis, and retained pregnancy tissue, and some have had to perform surgical abortions or remove fetal remains despite moral objections.
Procedural Posture:
- November 2022: Alliance for Hippocratic Medicine and other plaintiffs (physicians and physician organizations) sued the Food & Drug Administration (FDA), Department of Health and Human Services (HHS), and several agency heads in their official capacities, in the U.S. District Court for the Northern District of Texas.
- Plaintiffs immediately moved for a preliminary injunction ordering FDA to withdraw or suspend its 2000 Approval and 2019 Generic Approval of mifepristone, its 2016 Major REMS Changes, and its 2021 Mail-Order Decision and 2021 Petition Denial.
- Danco Laboratories, L.L.C., the exclusive manufacturer of Mifeprex, intervened as a defendant.
- April 7, 2023: The district court entered an order staying the effective date of the FDA's 2000 Approval and each of the subsequent challenged actions, effectively removing mifepristone from the market.
- The district court stayed its own order for seven days to allow the defendants to appeal.
- Defendants FDA, HHS, and Danco Laboratories, L.L.C. (appellants) appealed the district court's order to the United States Court of Appeals for the Fifth Circuit and moved for a stay pending appeal. Plaintiffs (appellees) moved to dismiss the appeal.
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Issue:
Should the Fifth Circuit Court of Appeals grant a stay pending appeal of a district court order that effectively removed mifepristone from the market, considering the likelihood of success on the merits of challenges to FDA's actions (including standing, timeliness, and arbitrary-and-capricious review), irreparable injury to applicants, injury to other parties, and the public interest?
Opinions:
Majority - Per Curiam
Yes, in part, as to the challenges to the 2000 Approval and 2016 Petition Denial, but No, in part, as to the challenges to the 2016 Major REMS Changes and subsequent FDA actions. The Court granted the defendants' motion for a stay pending appeal in part, stopping the district court's order from reinstating the 2000 Approval's original restrictions but not from reversing the FDA's regulatory changes from 2016 onward. First, on standing, the Court found that individual plaintiff doctors and plaintiff associations likely have standing. Doctors demonstrated concrete, particularized, and imminent injury because they have provided and, with statistical certainty from FDA's own 'Patient Agreement Form,' will continue to provide emergency care for complications arising from mifepristone use. This includes performing surgical procedures or removing fetal remains due to chemical abortion failures, which poses an 'irreconcilable choice' and 'enormous stress and pressure' for doctors with moral objections to abortion. Plaintiff associations have associational standing on behalf of their thousands of members and also suffered independent organizational injury by expending resources to compensate for FDA's elimination of non-fatal adverse event reporting. Second, regarding timeliness, challenges to the 2000 Approval and the 2016 Petition Denial (of the 2002 Citizen Petition) are likely time-barred by the six-year statute of limitations (28 U.S.C. § 2401(a)) because the right of action accrued in March 2016, and suit was filed in November 2022. The Court found applicants did not strongly show that FDA 'reopened' these decisions or that equitable tolling applied. However, challenges to the 2016 Major REMS Changes, 2019 Generic Approval, 2021 Mail-Order Decision, and 2021 Petition Denial (of the 2019 Citizen Petition) are timely because the right of action accrued in December 2021 when FDA denied the 2019 Citizen Petition challenging these changes. Third, on exhaustion, the Court found plaintiffs properly exhausted claims related to the post-2016 actions through the 2019 Citizen Petition. For claims not explicitly exhausted, the Court noted the futility exception, as FDA had already rejected similar challenges, and administrative abuse of process, due to FDA’s 'plainly and repeatedly' failing to follow its own 180-day deadline for responding to citizen petitions (taking 14 years for the first petition and over two years for the second). Fourth, concerning the arbitrary-and-capricious standard, the Court found applicants failed to show that FDA's post-2016 actions were not arbitrary and capricious. FDA eliminated REMS safeguards (like in-person dispensing) based on studies that included those very safeguards, demonstrating a failure to 'examine the relevant data' for the altered conditions. Furthermore, FDA's elimination of non-fatal adverse event reporting, followed by using the resulting absence of data to support the drug's safety, was deemed an 'ostrich’s-head-in-the-sand approach' and 'outside the zone of reasonableness.' Finally, for the remaining Nken factors, FDA failed to articulate its own irreparable harm absent a stay. While Danco claimed catastrophic financial loss, the Court noted that the nation operated under the 2000 Approval's original REMS for 16 years without such issues, undermining the claim that all of the district court’s order was necessary to prevent irreparable harm. The Court found substantial injury to the plaintiff doctors and associations from the ongoing complications and emotional strain if the stay were granted, particularly regarding the post-2016 changes. Public interest concerns regarding drug withdrawal were primarily tied to the district court’s order halting the entire approval, not specifically the post-2016 changes which were not in effect for 16 years. The Court also noted that a literal interpretation of the Comstock Act (prohibiting interstate carriage of abortion-inducing drugs) would undermine applicants' claims for irreparable harm and public interest, rejecting arguments for implied repeal.
Analysis:
This case highlights the intricate balance between agency discretion, statutory interpretation, and judicial review, particularly concerning drug safety regulations and standing in a highly politicized context. The Fifth Circuit's partial stay underscores the high bar for litigants seeking to challenge agency actions that have been in place for extended periods, especially the initial approval. However, it also signals strong judicial oversight on subsequent agency decisions that alter established safety protocols without sufficient new data or rational explanation, reinforcing the 'arbitrary and capricious' standard under the Administrative Procedure Act. The Court's discussion of the Comstock Act, though not definitively resolved, introduces a significant historical legal dimension that could impact future federal drug regulation, especially if interpreted literally.
