Revoking regulations that relaxed restrictions on a commonly used abortion pill would have “disruptive consequences” for women and the U.S. Food and Drug Administration (FDA), the U.S. Department of Justice (DOJ) told the Supreme Court.
The FDA loosened restrictions in 2016 and 2021 on the abortion pill mifepristone.
A medication abortion generally involves the use of mifepristone, which blocks progesterone, a hormone, and misoprostol, which induces contractions. Misoprostol isn’t at issue in the current litigation.
Advocates for mifepristone say the current system by which the drug is provided is safe, while opponents say it puts women at risk by ignoring the safety measures that used to be in place.
At issue in the case is the FDA’s decision in 2016 to loosen prescription rules around mifepristone and then in 2021 to allow prescriptions to be sent by mail without the patient first visiting a physician in person.
The case is actually two lawsuits: FDA v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM. The Alliance for Defending Freedom is representing the AHM, various medical associations, and several medical doctors in the case.
Danco Laboratories makes the abortion pill mifepristone, which is also known as mifeprex and RU-486.
The case is the Supreme Court’s most important abortion-related case since its June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which found that there was no right to abortion in the U.S. Constitution. That ruling overturned Roe v. Wade (1973) and returned the regulation of abortion to the states.
In a virtual repeat of 2022 with Dobbs, the decision is expected by June, at which point it could become a political issue in the November elections. Political commentators say if the court reimposes the old abortion pill restrictions, voters will blame Republicans and Democrats will benefit politically.
The case goes back to April 2023, when Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, an appointee of President Donald Trump, ruled that the FDA was wrong to approve mifepristone for public use in 2000 and that the agency had deliberately dragged out judicial review of the drug for years. The judge also found that the FDA had improperly lifted restrictions related to accessing the drug.
The judge issued a preliminary nationwide injunction retroactively, staying the FDA’s approval.
Judge Kacsmaryk wrote that the FDA had violated the law by not properly assessing the risks posed by the drug before approving it, buckling under political pressure to get it on the market.
The DOJ appealed Judge Kacsmaryk’s decision, but the conservative-leaning U.S. Court of Appeals for the Fifth Circuit refused to block most of the order. The Fifth Circuit held that the FDA’s actions in 2016 and 2021 were probably unlawful—a finding that the FDA and Danco asked the Supreme Court to review.
In August 2023, the Fifth Circuit upheld the district judge’s restrictions on the abortion pill, holding that the FDA failed to give proper consideration to public safety concerns when approving it.
Much of the circuit court opinion focused on the issue of standing, the absence of which typically dooms a lawsuit.
The Fifth Circuit noted that the Alliance for Hippocratic Medicine and the other plaintiffs argued that they had “associational standing” because the various organizations involved in the lawsuit have members who “are likely to sustain injuries as a result of FDA’s actions.”
Biden Administration’s New Filing
In a new filing on Jan. 23, the Biden administration argued that the district court’s injunction constituted “disruptive nationwide relief that threatens profound harms to the government, the healthcare system, patients, and the public.”The AHM lacks standing to bring its lawsuit, U.S. Solicitor General Elizabeth Prelogar wrote.
An association asserting standing to sue on behalf of its members must show that at least one identified member has suffered or would suffer injury, she wrote, citing Summers v. Earth Island Institute (2009).
The AHM’s claim of associational standing “fails because they have not shown that any identified member faces any imminent, judicially cognizable injury—much less an injury fairly traceable to FDA’s 2016 and 2021 actions.”
“And respondents’ alternative assertion of organizational standing is likewise meritless,” Ms. Prelogar said.
Besides, the FDA’s action in 2016 was supported by “an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world.”
“The loss of access to mifepristone would be damaging for women and healthcare providers around the nation,” she wrote.
“For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma.”
The Supreme Court hasn’t yet scheduled an oral argument in the case but is expected to do so in the coming weeks.
