Supreme Court Pauses Abortion Drug Ruling After Fifth Circuit Allows Access But with Additional Restrictions
- April 14, 2023
***Breaking update: U.S. Supreme Court Justice Samuel A. Alito, Jr. administratively stayed an order that would have restricted access to the abortion pill, mifepristone, starting April 15. The stay is in effect until 11:59 p.m. (ET) on April 19. Alito also asked the plaintiffs in the litigation to file any responses with the Court by 12 p.m. (ET) on April 18.
The federal government had asked the Court to intervene after a Fifth Circuit panel only partially stayed a decision that overturned the Food and Drug Administration’s (FDA’s) approval mifepristone.
The appeals court found the challenge to the FDA’s decision to approve mifepristone more than two decades ago likely was untimely under the statute of limitations and stayed a decision blocking access to the drug nationwide while the appeal plays out. Alliance for Hippocratic Med. v. Food and Drug Admin., No. 23-10362 (5th Cir. Apr. 13, 2023).
However, the Fifth Circuit said claims related to more recent FDA action to expand access to the drug, including allowing it to be prescribed through ten weeks gestation and to be delivered by mail, were timely.
The panel found the government failed to show that plaintiff physicians and medical associations were “unlikely to succeed on the merits” of their claims and therefore refused to stay the portions of the lower court's order striking the FDA's loosening of certain regulatory restrictions on the drug since 2016.
“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Attorney General Merrick Garland said in an April 13 statement.
The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy up to seven weeks. In 2016, the FDA extended the drug’s availability through ten weeks gestation among other changes. The agency further loosened restrictions on the drug more recently, including allowing certified retail pharmacies to sell mifepristone directly to patients and for the drug to be delivered by mail. Mifepristone and a second drug misoprostol account for about half of abortions nationwide.
The Fifth Circuit's ruling follows the April 7 decision by U.S. District Court for the Northern District of Texas Judge Matthew J. Kacksmaryk that granted a preliminary injunction to plaintiffs who argued the FDA’s fast-track approval of the drug ignored safety concerns and was politically motivated. Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-223-Z (N.D. Tex. Apr. 7, 2023).
“The Court does not second-guess FDA’s decision-making lightly,” Kacksmaryk wrote in the 67-page opinion. “But here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion,” according to the opinion.
Kacksmaryk stayed the order until April 14 to give the federal government time to seek emergency relief. The Department of Justice filed April 10 an emergency motion for a stay pending appeal of the “extraordinary and unprecedented order,” arguing among other things that plaintiff doctors and medical associations lacked standing to challenge the “approval of a drug they neither take nor prescribe.”
In the decision, Kacksmaryk found standing based on plaintiffs’ allegations, including that “adverse events from chemical abortion drugs can overwhelm the medical system" and "place ‘enormous pressure and stress’ on doctors during emergencies and complications.”
The Fifth Circuit said it appeared plaintiffs sufficiently demonstrated injuries for standing purposes, including “devot[ing] significant time and resources to caring for women experiencing mifepristone’s harmful effects” and the “‘enormous stress and pressure’ physicians face in treating these women.” According to the appeals court, its standing analysis was limited to the “exceedingly unusual regime” the FDA put in place for distribution of mifepristone and would not extend to other challenges by doctors seeing patients experiencing complications from an FDA-approved drug.
While finding only the post-2016 challenge was timely, the Fifth Circuit said the government “failed to carry their burden at this preliminary stage to show that FDA’s actions were not arbitrary and capricious” and thus refused to block that portion of Kacksmaryk's opinion from taking effect.
Meanwhile, short following Kacksmaryk’s ruling, U.S. District Court for the Eastern District of Washington Judge Thomas Rice, in a separate action brought by attorneys general of 17 states and the District of Columbia, preliminarily enjoined the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.” Washington v. U.S. Food and Drug Admin, No. 1:23-CV-3026-TOR (E.D. Wash. April 7, 2023).
While the injunction only applies in the states that brought the action and not nationwide, DOJ asked Rice in a subsequent filing to clarify how to proceed in the face of the conflicting rulings.