The Supreme Court granted a stay pending appeal on lower court orders restricting the use of the abortion pill on Friday, effectively preserving access to the drug.
Thanks to the ruling, the Food and Drug Administration’s (FDA) approval of mifepristone, a common abortion drug, will remain in place during the appeals process. Justices Clarence Thomas and Samuel Alito dissented from the 7-2 ruling.
The ruling means the Fifth Circuit’s decision to restrict FDA rules that allowed the abortion pill to be sent via mail and used later in pregnancy will not take effect.
The Department of Justice (DOJ) filed its emergency appeal April 14 asking the Supreme Court for both an administrative stay and a stay pending its appeal in the Fifth Circuit. The Supreme Court granted a five-day administrative stay last Friday to allow more time to decide, which it extended an additional two days on Wednesday.
Northern District of Texas Judge Matthew Kacsmaryk first issued a preliminary injunction on April 7 against the FDA’s approval of mifepristone, which was set to take effect seven days later. On the same day, a federal judge in Washington issued a conflicting ruling in a lawsuit by twelve Democratic state attorneys general ordering the FDA not to roll back approval.
Following the FDA’s swift appeal, the Fifth Circuit ruled 2-1 on April 12 to grant in part the FDA’s request for a stay on Kacsmaryk’s decision, lifting the total block on the abortion pill’s approval but leaving restrictions on rules issued by the agency after 2016 in place.
After 2016, the FDA eliminated key safeguards, allowing the pill to be sent through the mail and extending the latest date it could be used in pregnancy to 10 weeks. (RELATED: Federal Appeals Court Allows Abortion Pill Approval To Stand, With Restrictions)
In his dissent, Alito dispelled notions that denying a stay would indicate any view on “whether the FDA acted lawfully in any of its actions regarding mifepristone.”
“Rather, it would simply refuse to take a step that has not been shown as necessary to avoid the threat of any real harm during the presumably short period at issue,” he said. Alito also noted that the narrow stay put in place by the Fifth Circuit would not “remove mifepristone from the market” but would simply “restore the circumstances” that existed between 2000 and 2016.
“At present, the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim,” he said, going on to slam the FDA’s argument that lower court decisions would create regulatory “chaos.”
The FDA warned in its brief filed with the Supreme Court Tuesday night that allowing the lower court orders to stand would “scramble the regulatory regime governing a drug that FDA determined was safe and effective under the approved conditions and that has been used by more than five million American women over the last two decades.”
Abortion pill manufacturer GenBioPro also filed a lawsuit against the FDA on Wednesday to prevent it complying with court decisions requiring the agency to order mifepristone off the market.
WASHINGTON, DC – DECEMBER 01: (L-R) Lila Bonow, Alana Edmondson and Aiyana Knauer prepare to take abortion pill while demonstrating in front of the U.S. Supreme Court as the justices hear hear arguments in Dobbs v. Jackson Women’s Health, a case about a Mississippi law that bans most abortions after 15 weeks, on December 01, 2021 in Washington, DC. (Photo by Chip Somodevilla/Getty Images)
The lawsuit, brought by the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations and several doctors, has been closely watched since the beginning, with nearly every state weighing in.
Plaintiffs argued that the FDA lacks authority to approve mifepristone. When it approved the pill in 2000, it did so under accelerated approval regulations that forced it to categorize pregnancy as an “illness” and the pill as providing “meaningful therapeutic benefit,” according to the lawsuit.
The pill poses real health risks to women and girls, the plaintiffs argued, citing a study showing women who receive chemical abortions are 50% more likely than those who receive surgical abortions to visit the emergency room within thirty days.
“As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” President Biden said in a statement. “I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”
“The stakes could not be higher for women across America. I will continue to fight politically-driven attacks on women’s health,” he continued.
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