Abortion Opponents Seek Full Supreme Court Review of Fifth Circuit Holding

In response to Danco Laboratories (“Danco”) petition for a Writ of Certiorari to the U.S. Supreme Court seeking review of an appellate panel’s decision upholding Judge Kacsmaryk’s order reinstating the 2011 FDA restrictions on mifepristone, Alliance for Hippocratic Medicine (“Alliance”) filed a Conditional Cross-Petition For A Writ of Certiorari (“Conditional Petition”) on Thursday, October 12, 2023, urging the Supreme Court to review the entire Fifth Circuit decision if the Danco Writ of Certiorari is granted.

As we reported in our September 20, 2023 alert, Danco petitioned, among other things, that by ordering a return to the pre-2016 labeling, the Fifth Circuit has required Danco to abide by an obsolete and less effective dosing regimen, along with dated guidance for the use of mifepristone.

Alliance presented to the Supreme Court primarily two arguments: (1) that the initial approval of mifepristone was politically charged, and (2) that Alliance’s challenge to the FDA’s 2000 approval is not untimely.

Alliance claims that the FDA disregarded law, science, and safety in pursuit of a political end. Specifically, Alliance stated as follows:

• From the beginning, political actors have orchestrated mifepristone’s approval and deregulation;
• The FDA approved mifepristone despite the agency’s reservations about the drug’s safety; and
• FDA’s 2000 approval relied on one U.S. and French clinical trials that all included safeguards, which were not incorporated into the approved labeling.

See Conditional Petition at pages 11-13. Alliance goes on to state that the “FDA’s accelerated approvals are also emblematic of the agency’s penchant to subordinate patient safety to politics.” Id. at page 14. 

Alliance’s petition argues that the Fifth Circuit erred in concluding that its 2000 challenge was untimely. Specifically, Alliance stated as follows:

• The FDA’s 2016 and 2021 actions necessarily reconsidered and revised the 2000 Approval by re-evaluating and changing the safeguards essential to that original approval;
• The FDA’s express re-examinations reopened that initial decision and restarted the clock to challenge it; and
• In these unique circumstances, reopening simply reflects the commonsense proposition that the entirety of a final agency action is reviewable under the APA.

See Conditional Petition at pages 19-20.

Alliance is requesting that the issues presented by Danco and those presented in its cross-petition be considered together. If the Supreme Court does determine that full review is warranted, the FDA’s 2000 approval of mifepristone is at risk. At issue is whether the United States Supreme Court finds that the FDA acted illegally in error of the law in connection with its historical approval of mifepristone.

As new developments arise, we will continue to update our Dobbs Decision Resource Center. In the meantime, please contact one of the lawyers in Shipman’s Health Law practice group if you have questions about this ever-changing legal landscape.

*Ian Leon also contributed to the writing of this article. Ian is not yet admitted to practice.