WASHINGTON — The Biden administration on Friday asked the Supreme Court to maintain broad access to a commonly used medication abortion pill.
The court filing from the Justice Department sets the stage for a possible final resolution to a contentious legal fight mounted by abortion rights opponents over federal approval of the drug mifepristone. The dispute lands at the Supreme Court in time for the justices to potentially take it up, hear oral arguments and issue a decision by next summer.
In urging the Supreme Court to intervene, Solicitor General Elizabeth Prelogar wrote that the case marked the first time a court has ever second-guessed the “expert judgment” of the Food and Drug Administration in approving a drug.
If lower court rulings were left in place, they “would impose grave harms on the government, mifepristone’s sponsors, women seeking medication abortions, and the public,” Prelogar added. Among other things, access to the pill by mail — which the FDA formally approved in 2021 — would be curtailed.
Danco — the maker of Mifeprex, the brand version of mifepristone — filed a similar appeal Friday.
Before making a decision on whether to hear the case, the justices will receive a response from the challengers as part of a process that can take months.
The justices have already intervened once, back in April, when they blocked in full a decision by Texas U.S. District Judge Matthew Kacsmaryk that had invalidated the FDA’s original approval of the drug from more than 20 years ago. At that time, conservative justices Clarence Thomas and Samuel Alito said they would have allowed part of Kacsmaryk’s ruling to go into effect.
Kacsmaryk’s decision threatened access to the pill, including its availability by mail, but the Supreme Court order resulted in it remaining available as normal while the litigation continues.
The challenge has been brought by a group of doctors and other medical professionals represented by the conservative Christian legal group Alliance Defending Freedom. They claim that the FDA’s 2000 approval was flawed, as were later decisions that made the drug easier to access, in part because they failed to take into account safety risks to women. The FDA and Danco say that serious adverse effects are “exceedingly rare.”
Since the Supreme Court’s action in April, the case has moved as normal through the appeals process, with the New Orleans-based 5th U.S. Circuit Court of Appeals last month upholding part of Kacsmaryk’s decision on the steps the FDA took to loosen restrictions on the pill, including making it available by mail. That prompted the Biden administration and Danco to turn once again to the high court.
If the justices refuse to take the case, then the 5th Circuit decision will take effect nationwide. This “would upend the regulatory regime for mifepristone, with damaging consequences for women seeking lawful abortions and a health care system that relies on the availability of the drug under the current conditions of use,” Prelogar said.
In that scenario, access to the pill would be curtailed in significant ways. Women will no longer be allowed to receive it by mail — and instead will need to make several trips, in person, to a doctor’s office. A higher dose of the medication will be required as well, since the older dosing regimen was changed in 2016.
Although the Supreme Court in 2022 overturned the landmark Roe v. Wade decision that ensured a constitutional right to abortion and has a 6-3 conservative majority, the mifepristone litigation raises very different legal issues, and the court’s earlier intervention means the challengers could face an uphill battle to prevail.
The FDA-approved regimen for a medication abortion involves a combination of two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions. A majority of abortions in the U.S. are carried out using those pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights. Access to misoprostol was not at issue in the lawsuit.
Lawrence Hurley reported from Washington, Laura Jarrett reported from New York.