The US Supreme Court will hear arguments on March 26 in Alliance for Hippocratic Medicine v. FDA, a case in which lower court judges ruled to reinstate burdensome restrictions on the abortion drug mifepristone.
Medication abortion is the most commonly used method of abortion in the United States, accounting for more than half of all abortions. Mifepristone is part of a two-drug regimen for medication abortion and was first approved by the U.S. Food and Drug Administration in 2000.
The case filed by anti-abortion advocates is challenging the FDA’s approval of the drug places medication abortion at risk across the U.S.
Since its approval, the mifepristone has established a well-documented safety record, as demonstrated by its real-world use by more than five million people as well as hundreds of additional high-quality studies.
This lawsuit—filed by anti-abortion advocates against the FDA and the U.S. Health and Human Services (HHS) in November 2022—challenges the FDA’s initial approval of mifepristone as well as its more recent actions to increase access to the drug.
If the lawsuit succeeds, access to the most common medication abortion regimen used in the U.S. would end across the country—even in those states where abortion rights are protected.
New Jersey Democrat Lisa McCormick, an advocate for women’s rights, has called on the Biden administration to make Misoprostol and Mifepristone available over the counter in all states.
“In a nutshell, this case is an attempt to have a nationwide ban on medication abortion,” says Jenny Ma, senior counsel at the Center for Reproductive Rights.
The FDA, in response to the lawsuit, claimed, “The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years.” In the U.S., medication abortion accounts for more than half of all abortions.
“Overturning Roe v. Wade was just the beginning for the anti-abortion movement in the United States,” said Ma. “For years, anti-abortion advocates claimed that abortion should be left to each state—but it’s clear that their real goal was always to ban abortion nationwide.”
Leading medical organizations—including the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG)—have repeatedly expressed concern over the lack of access to abortion on patients’ health.
ACOG and the AMA predict that the country’s maternal mortality crisis will worsen without access to abortion care, including medication abortion. In a statement, pharmacist organizations raised concerns about the risks to patients’ health without access to mifepristone, which is also used to treat ectopic pregnancies, miscarriages, and other medical conditions.
In addition to endangering access to medication abortion, the lawsuit also threatens the FDA’s authority over the drug approval process, which could severely limit the development of new drugs overall and have far-reaching repercussions on patients’ access to FDA-approved medications.
The Center for Reproductive Rights and its movement partners have submitted amicus briefs in this case supporting the FDA’s approval of the medication. Leading pharmaceutical companies, medical and health organizations, members of Congress, government officials, rights and justice groups, and other experts have also submitted amicus briefs in support of the FDA.
The Center for Reproductive Rights and its partners warned the U.S. Supreme Court about “junk science” and unreliable witnesses in the case that threatens abortion medication.
In an amicus (“friend of the court”) brief, submitted January 30 in support of the FDA’s actions on mifepristone, the Center for Reproductive Rights, the American Civil Liberties Union, and The Lawyering Project outline how the lower courts in their rulings relied on “patently unreliable witnesses” and “ideologically tainted junk science” that have been “routinely discredited” by other courts.
A federal district court in Texas issued a decision on April 7 attempting to block the long-standing FDA approval of mifepristone. If allowed to take effect, it would be a devastating blow to abortion access across the country.
The U.S. Department of Justice appealed the decision on April 10 to the Fifth Circuit Court of Appeals.
On April 12, the Fifth Circuit issued a ruling largely refusing to block the federal district court’s order and attempting to reinstate burdensome restrictions from pre-2016.
The Department of Justice announced on April 13 that it would seek emergency relief from the U.S. Supreme Court and filed an emergency application with the Court the following day.
On April 14, the U.S. Supreme Court issued a temporary stay through April 19, preventing the district court’s order from taking effect. On April 19, the Court extended its stay until Friday, April 21, at 11:59 p.m.
On April 21, the Supreme Court granted a stay of the lower court decision, leaving mifepristone on the market while the case proceeds at the Fifth Circuit Court.
Oral arguments at the Fifth Circuit were held May 17.
On August 16, the Fifth Circuit Court of Appeals ruled to reinstate burdensome pre-2016 restrictions on mifepristone, but not to remove the drug from the market. Due to the U.S. Supreme Court’s April 21 order, mifepristone will remain available under current regulations while the case continues.
On September 8, the U.S. Department of Justice filed a writ of certiorari to the U.S. Supreme Court asking it to review the August 16 ruling by the Fifth Circuit.
On December 13, the U.S. Supreme Court agreed to review the case and announced on January 29 that it would hear oral arguments on March 26, 2024.