Alliance Hippocratic Medicine v. FDA
23-10362, Document 00516860229, Filed 08/16/2023 (2023)
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Rule of Law:
An agency's actions are arbitrary and capricious under the Administrative Procedure Act if it fails to consider important aspects of a problem, relies on unreliable data, or provides an inadequate explanation for its decisions, particularly when modifying drug safety regulations.
Facts:
- In March 1996, the Population Council applied for FDA approval of mifepristone as part of a two-drug regimen to cause abortion, based on clinical studies showing adverse events for some women, including required surgical intervention.
- In September 2000, the FDA approved mifepristone (brand name Mifeprex) under its accelerated approval (Subpart H) regulations, imposing several safeguards including limiting use to 49 days gestation, physician-only prescription, in-person visits, and reporting of serious adverse events.
- In March 2016, the FDA denied a 2002 citizen petition to revoke mifepristone's approval and approved a supplemental new drug application, making "major" amendments to the Mifeprex REMS (Risk Evaluation and Mitigation Strategy) that loosened restrictions, such as increasing gestational age limit to 70 days, allowing non-physician prescribing, and eliminating reporting of non-fatal adverse events.
- In April 2019, the FDA approved an abbreviated new drug application for a generic version of mifepristone, relying on the same data as the 2000 approval and 2016 amendments.
- In April 2021, the FDA announced it would not enforce the in-person dispensing requirement for mifepristone due to the COVID-19 pandemic, effectively allowing remote prescription and mail delivery.
- In December 2021, the FDA denied a 2019 citizen petition challenging the 2016 amendments and stated its intent to permanently remove the in-person dispensing requirement, formalizing this change in January 2023.
- Medical organizations and individual doctors allege that treating women experiencing mifepristone complications (e.g., heavy bleeding, infection, incomplete abortion) injures them by forcing them to violate their moral beliefs, causing mental/emotional distress, diverting resources, and increasing malpractice risk and insurance costs.
Procedural Posture:
- The Alliance for Hippocratic Medicine and other medical organizations and individual doctors filed a complaint in the United States District Court for the Northern District of Texas, alleging that the FDA's 2000 Approval, 2016 Amendments, 2019 Generic Approval, and 2021 Non-Enforcement Decision violated the Administrative Procedure Act.
- Danco Laboratories, LLC, the manufacturer and distributor of Mifeprex, intervened in the district court proceedings.
- The Medical Organizations and Doctors filed a motion for preliminary injunctive relief, seeking to prevent their alleged injuries.
- The district court granted the motion in part, staying the effective date of each of the challenged FDA actions under 5 U.S.C. § 705.
- The FDA and Intervenor Danco Laboratories, LLC, appealed the district court's order to the United States Court of Appeals for the Fifth Circuit and moved to stay the district court’s order pending appeal.
- A Fifth Circuit motions panel stayed the district court’s order in part, specifically staying the portion relating to the 2000 Approval but not disturbing the parts concerning the 2016 Amendments, 2019 Generic Approval, and 2021 Non-Enforcement Decision.
- The FDA and Danco then applied to the Supreme Court for a full stay of the district court’s order, which was granted, staying the district court’s order pending the Fifth Circuit's appeal resolution and any petition for a writ of certiorari.
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Issue:
Does the FDA's 2016 amendments to mifepristone's conditions for use and its 2021 decision to no longer enforce in-person dispensing requirements violate the Administrative Procedure Act by being arbitrary and capricious, and do the plaintiff medical organizations and doctors have standing to challenge these actions and the 2000 approval or 2019 generic approval?
Opinions:
Majority - Jennifer Walker Elrod
Yes, the Medical Organizations and Doctors have standing to challenge the 2016 Amendments and the 2021 Non-Enforcement Decision, and these actions were likely arbitrary and capricious under the Administrative Procedure Act; however, the claim against the 2000 Approval is untimely, and there is no standing to challenge the 2019 Generic Approval. The court found that the Medical Organizations and Doctors demonstrated associational standing to challenge the 2016 Amendments and 2021 Non-Enforcement Decision. Their members (OB/Gyns and emergency-room doctors) face a "fairly likely" and "substantial risk" of imminent injury due to increased complications from mifepristone. These injuries are cognizable, including economic harms (diversion of time/resources, increased liability/insurance) and conscience injuries from being forced to participate in or complete abortions against their moral beliefs, especially given the government's conflicting positions on federal conscience protections. The court rejected standing for the 2019 Generic Approval, finding no evidence that it contributed to an increased risk of harm. The court also declined to rule on third-party standing but noted its likely applicability given the close relationship between doctors and patients. Regarding the 2000 Approval, the court determined the claim was untimely, as neither the "reopening doctrine" nor "equitable tolling" applied. The 2016 Amendments and 2021 Petition Denial did not constitute a "serious, substantive reconsideration" of the 2000 approval nor did they "significantly alter the stakes of judicial review" in a way that would constructively reopen the original approval. Furthermore, the plaintiffs offered no extraordinary circumstance preventing timely filing. The 2016 Amendments were likely arbitrary and capricious because the FDA failed to consider the cumulative effect of all the significant changes (e.g., increased gestational age, non-physician prescribing, remote follow-up) together, only examining them individually. The FDA also failed to explain why it eliminated the requirement for prescribers to report non-fatal adverse events, especially after significantly loosening other restrictions, thereby ignoring an important aspect of patient safety data collection. The 2021 Non-Enforcement Decision (allowing remote dispensing) was not moot, as the policy's effects remained the same even after formalization. It was likely arbitrary and capricious because the FDA gave "dispositive weight" to adverse-event data from FAERS, a voluntary reporting system it acknowledged has "uncontested limitations" and cannot be used to calculate incidence rates. This reliance was especially problematic after the FDA had eliminated prescriber reporting of non-fatal events. Additionally, the FDA relied on published literature that it admitted was only "not inconsistent" with its conclusion, rather than affirmatively supporting it, and noted significant limitations in those studies. The court found that the threatened injuries were irreparable, as no legal remedy could adequately address the conscience and mental-distress injuries, and monetary harm was unrecoverable due to sovereign immunity. The balance of equities and public interest favored the Medical Organizations and Doctors, as there is no public interest in unlawful agency action. The Supreme Court's stay pending appeal and certiorari provided sufficient time for Danco to adapt, mitigating potential harm to the drug manufacturer. The form of relief, a stay of the effective dates, was appropriate as a temporary form of vacatur, which is the default remedy for unlawful agency action under the APA.
Concurring in part and dissenting in part - James C. Ho
I concur that the FDA's 2016 and 2021 revisions to mifepristone regulations are arbitrary and capricious under the APA, and that the plaintiffs have standing to challenge these actions. However, I dissent from the majority's conclusion that the claim challenging the 2000 Approval is untimely and that the 2021 revisions do not violate the Comstock Act. I agree that plaintiffs have standing, emphasizing the historical pedigree of conscience injury and introducing the concept of "aesthetic injury" for doctors who experience profound joy in unborn life and suffer when that life is destroyed. I believe the challenge to the 2000 Approval is timely under the "constructive reopening" doctrine. The 2016 and 2021 revisions significantly altered the regulatory scheme by removing key safeguards (e.g., increased gestational age, non-physician prescribing, elimination of in-person follow-up, mail-order dispensing), making the original approval much more "worth challenging." The FDA itself described these changes as "upend[ing] the regulatory regime." On the merits, the 2000 Approval was unlawful because the FDA approved mifepristone under Subpart H (21 C.F.R. § 314.500), which only applies to drugs treating "serious or life-threatening illnesses." Pregnancy is plainly not an illness, a point conceded by the drug's sponsor, the Population Council. The FDA's attempts to broaden "illness" or deny reliance on Subpart H are contradicted by the clear regulatory text and its own historical statements. The 2007 FDA Amendments Act and the 2011 REMS did not cure this initial defect. Furthermore, the 2021 Non-Enforcement Decision (allowing mail-order dispensing) violates the Comstock Act (18 U.S.C. §§ 1461, 1462), which makes it a federal crime to use the mails or common carriers for "any drug, medicine, or thing designed, adapted, or intended for producing abortion." The FDA's arguments against this plain reading are atextual and inconsistent with legislative history and judicial precedent. Congressional attempts to amend the Comstock Act to apply only to "illegal abortions" or remove "abortion" entirely have been rejected. I would therefore also set aside the 2021 Mail-Order Decision for violating the Comstock Act. Finally, I emphasize that courts should not offer "blind deference" to the FDA, as Congress mandates judicial review of agency actions under the APA. The FDA has a history of mistakes, approving ineffective or harmful drugs (e.g., Makena, DES) and contributing to crises (e.g., opioid crisis), demonstrating that its scientific judgments are not immune from error and require judicial oversight.
Analysis:
This case significantly reinforces the scope of judicial review under the Administrative Procedure Act, particularly concerning federal agency decisions on drug safety. It highlights the FDA's obligation to rigorously support its decisions, especially when loosening safety protocols for drugs. The ruling establishes that the FDA cannot ignore the cumulative effects of multiple regulatory changes, nor can it rely on incomplete or unreliable data (like voluntary reporting systems) to justify significant alterations to a drug's risk management strategy, particularly when the agency itself contributed to the data deficiencies. The opinion's detailed examination of standing, including a robust discussion of conscience-based and economic injuries, may also influence future challenges to regulatory actions that indirectly impact medical professionals. Judge Ho's concurring/dissenting opinion, with its expansive view on constructive reopening and the application of the Comstock Act, suggests potential avenues for future legal challenges to drug approvals, particularly in politically charged areas like abortion, that could reach the Supreme Court.
