The Fifth Circuit’s partial stay to the mifepristone order grants partial relief, but leaves many questions

On April 13, 2023, the Department of Justice announced that it plans to seek emergency relief from the Supreme Court after the Fifth Circuit partially allowed a Texas court’s order staying FDA authorization of mifepristone to go into effect.

On April 7, the Northern District of Texas blocked the FDA’s approval of the abortion pill mifepristone, along with all subsequent FDA actions that had expanded access to the drug, in Alliance for Hippocratic Medicine v. United States Food and Drug Administration, No. 2:22-CV-223-Z, -- F. Supp. 3d -- (N.D. Tex. Apr. 7, 2023).  The court’s ruling was scheduled to take effect nationwide on April 13.

The Department of Justice and Danco Laboratories (the manufacturer of the brand drug) both appealed to the US Court of Appeals for the Fifth Circuit and filed request for an emergency stay of the district court’s decision. The Fifth Circuit granted a partial stay of the order’s effect pending resolution of the appeal.  See Alliance for Hippocratic Medicine v. FDA, No. 23-10362, ECF No. [183-2] (5th Cir. Apr. 12, 2023) (the Order).

On April 12, the Fifth Circuit stayed the portion of the lower court’s decision that effectively unwound the FDA’s original approval of mifepristone in September 2000. The Fifth Circuit did so because, on abbreviated review, they determined that the plaintiff’s challenge to the FDA’s approval nearly 23 years earlier was untimely.

When FDA approved mifepristone in 2000, FDA incorporated post-market restrictions to “assure safe use,” which included (1) limiting drug use through 49 days gestation; (2) requiring three in-person office visits; (3) requiring the supervision of a qualified physician; and (4) requiring the reporting of all adverse events from the drugs.  See Order at 4.

In 2016, FDA approved changes to the 2000 restrictions to: (1) increase the maximum gestational age to 70 days; (2) reduce the number of in-person office visits to one; (3) expand the prescribing and administration of mifepristone to additional healthcare providers who were not physicians; and (4) limit the adverse reporting requirement to fatal adverse events. In 2019, FDA approved a generic version of mifepristone and imposed the same 2016 post-market restrictions.  In January 2023, FDA modified the restrictions, eliminating the in-person dispensing requirement.

The Fifth Circuit left intact the lower court’s stay of everything but the 2000 approval and found unconvincing FDA’s arguments about harm caused by allowing the district court’s unwinding of the post-2000 REMS changes.

Meanwhile, also on April 7, 2023, a federal district court in the Eastern District of Washington ordered FDA to maintain the same approval and distribution standards in place for mifepristone in 18 states that sought increased access to mifepristone.  See Washington v. FDA, No. 1:23-CV-3026-TOR, -- F. Supp. 3d – (E.D. Wash. Apr. 7, 2023).  In response to the Department of Justice’s request for clarification, the district court confirmed that it intended its ruling to preserve the post-market restrictions FDA had approved as of January 2023.

Unless the Supreme Court alters the Fifth Circuit’s stay – to either reinstate the district court’s ruling pending appeal or to grant further relief – the following guidelines will apply pending appeal in at least 32 states:

• FDA’s 2000 approval of mifepristone remains intact.  Mifepristone is still an FDA-approved drug, but the drug’s use:
  • is limited through 49 days gestation
  • requires three in-person office visits
  • requires the supervision of a qualified physician
  • all adverse events must be reported and
  • must be dispensed in-person.
• The 2000 REMS requirements remain intact, while the 2016 REMS modifications are stayed.
• The 2019 generic approval is stayed.
• The January 2023 REMS modification is stayed.

Regardless of what the Supreme Court decides with respect to the emergency application to alter the parameters of the Fifth Circuit’s stay, the case will almost certainly end up back before the Supreme Court given the irreconcilable conflict between two federal district court decisions, following the Fifth Circuit’s resolution on an expedited appellate briefing schedule.

As highlighted in our earlier alert, the case raises several novel issues for life sciences companies broader than the debate regarding the mifepristone medication.

The first is whether to implement contingency plans for the potential partial or complete unraveling of FDA authorizations through judicial intervention.  Given the success of the operative citizen petitions in this case, we may see similar strategies employed to target other pharmaceuticals by other medical organizations, individual and class action plaintiffs, and competitors.  The determining factors behind potential contingency approaches are certainly context- and case-specific.

Another is anticipating similar challenges during premarket clinical development and throughout the FDA approval process.  For example, because the Fifth Circuit’s ultimate decision is not limited to the issues discussed in the stay order, one area of potential focus in the ultimate decision may be the mismatch between the FDA clinical trials and the ultimate approval, as discussed by the Northern District of Texas opinion.

Further, although the Fifth Circuit’s stay ruling did not definitively address the lower court’s conclusion that the Comstock Act prohibits the mailing of abortion drugs, interesting questions remain regarding the intersection of the Federal Food, Drug, and Cosmetic Act, Supreme Court rulings, and the Comstock Act. The Supreme Court may eventually reach these issues, if the case is not decided on threshold grounds, such as standing, timeliness, or exhaustion.

DLA Piper’s team of product liability, FDA regulatory, and appellate attorneys is ready to help you evaluate the risks posed by this decision to future challenges and to suggest concrete measures to mitigate those risks. Contact the authors or your DLA Piper attorney contact for further discussion.