CSPI joined an amicus brief filed at the U.S. Supreme Court supporting FDA’s decision to increase access to the drug mifepristone.
In January 2024, Public Citizen and CSPI, represented by Public Citizen Litigation Group, filed an amicus brief at the Supreme Court supporting the FDA’s decision to increase access to the approved drug mifepristone, a safe and effective medication used to terminate early pregnancies. In the brief, CSPI and Public Citizen argue that, because of FDA’s rigorous drug approval process, there should be a high bar for overruling its determination that a drug is safe and effective, and the plaintiffs did not come close to meeting that burden.
Mifepristone is an FDA-approved drug that is ordinarily used in a regimen with another drug, misoprostol, to end an early pregnancy. Millions of women have effectively used mifepristone to terminate early pregnancies, and years of evidence and countless studies have demonstrated that the medication is safe and effective.
In 2000, after an exhaustive review of the evidence, the FDA approved the use of mifepristone, concluding the drug was safe and effective when used under certain conditions. Among those original conditions imposed by FDA, mifepristone could only be prescribed for women who have been pregnant for seven weeks or less and could only be dispensed in person by certain physicians. FDA also required patients to make three clinical visits: one to take mifepristone, one to take the misoprostol, and a third follow-up visit.
In 2016, based on a comprehensive review of the evidence, FDA concluded that mifepristone could be safely and effectively used with fewer restrictions. Among other things, FDA increased the gestational age limit to ten weeks, permitted appropriately licensed non-physicians to prescribe the drug, and reduced the number of required clinical visits to one, the visit to take mifepristone.
In 2023, based in part on its experience during the pandemic, during which time FDA temporarily permitted remote prescribing of mifepristone, the agency also removed the in-person prescribing requirement. The combined effect of these changes made mifepristone, a critical and safe medication for terminating an early pregnancy, more accessible to hundreds of thousands of women.
The Lawsuit and Proceedings Below
In 2022, four doctors and four doctors’ associations that are opposed to abortion challenged FDA’s approval of mifepristone and its later decisions to modify the restrictions on mifepristone’s use. The plaintiffs argued, among other things, that FDA’s evaluation of the evidence of mifepristone’s safety and effectiveness was arbitrary and capricious in violation of the Administrative Procedure Act.
In April 2023, District Judge Matthew Kacsmaryk, a Trump appointee who has been the object of forum shopping by conservative groups and states seeking favorable decisions, ruled in favor of the plaintiffs. In an unprecedented decision, Judge Kacsmaryk issued a stay on FDA’s 2000 decision approving mifepristone, which could have effectively barred mifepristone’s use nationwide.
The FDA appealed the District Court decision to the Fifth Circuit. In April 2023, the Fifth Circuit paused the Kacsmaryk Order in part during the pendency of the appeal, allowing continued use of mifepristone, but restored the original, more onerous restrictions of use. In August 2023, the Fifth Circuit issued a decision on the appeal. The Court held that too much time had lapsed for the plaintiffs to challenge mifepristone’s original approval, but it determined that FDA’s later decisions to remove restrictions on mifepristone’s use were arbitrary and capricious.
Specifically, the Fifth Circuit determined that FDA did not have sufficient evidence that mifepristone could be safely prescribed remotely and that the agency failed to consider the impact of modifying mifepristone’s conditions of use collectively, as opposed to analyzing the impact of each modification separately. The Fifth Circuit required FDA to continue to enforce mifepristone’s original conditions of use.
FDA appealed. The Fifth Circuit’s decision is now being considered by the Supreme Court.
The Amicus Brief
In January 2024, Public Citizen and CSPI filed their Supreme Court amicus brief in support of FDA. Although there are myriad errors in the Fifth Circuit’s decision, including its determination that the plaintiffs had suffered a sufficient injury to bring the case and the Fifth Circuit’s choice of remedy, the amicus brief focused on the merits of the case.
Specifically, the brief argued that, given the FDA’s expertise, the data required to be submitted to the agency to support a new drug application, and its rigorous review of that data, there should be an extremely high bar for second-guessing FDA’s determination that a drug is safe and effective. It argued that, only where there is a meaningful procedural breakdown in the FDA’s approval process, departure from accepted scientific principles, or discovery of new, material information that reasonably should alter FDA’s prior analysis, should a court reasonably conclude that FDA’s drug approval decision is arbitrary and capricious. As the amicus brief discusses in detail, the plaintiffs in this matter fell well short of that bar.
As FDA watchdogs, CSPI and Public Citizen are frequent critics of the agency, are under no illusions as to its fallibility, and have filed numerous citizen petitions challenging FDA actions. But, FDA’s drug review process, particularly in the mifepristone case, is comprehensive, carefully performed, and reflects its wide expertise. As such, its decisions should be deferred to by the courts, absent unusual circumstances.