On Friday, the Biden administration requested the Supreme Court to protect easy access to a routinely prescribed abortion drug.
The government approval of the medicine mifepristone has been the subject of a bitter legal battle between proponents of abortion rights and opponents, and the Justice Department’s court submission paves the way for a potential ultimate settlement. The case comes before the Supreme Court just in time for the justices to decide whether or not to take it up, hear oral arguments, and deliver a ruling by next summer.
Elizabeth Prelogar, the solicitor general, urged the Supreme Court to get involved, stating that this was the first instance in history where a court has questioned the “expert judgment” of the Food and Medicine Administration in approving a medicine.
Prelogar noted that the continuation of lower court decisions “would impose grave damages on the government, mifepristone’s sponsors, women wanting medication abortions, and the public.” The FDA officially approved the pill in 2021, and access to it via mail would be restricted among other things.
The manufacturer of Mifeprex, the brand name for mifepristone, Danco, submitted a similar appeal on Friday.
The justices will wait for a response from the challengers as part of a procedure that might take months before deciding whether to hear the case.
The Supreme Court has already taken action once, blocking in its entirety a ruling by Texas U.S. District Judge Matthew Kacsmaryk in April that had overturned the FDA’s initial clearance of the medicine more than 20 years prior. At the time, conservative justices Samuel Alito and Clarence Thomas declared they would have permitted a portion of Kacsmaryk’s decision to take effect.
The Supreme Court’s ruling ensured that the pill will continue to be supplied as usual while the legal dispute is ongoing, despite Kacsmaryk’s decision posing a threat to access, including mail-order availability.
A group of doctors and other medical experts who are being defended by the conservative Christian legal organization Alliance Defending Freedom have filed the lawsuit. They contend that the FDA’s approval of the medicine in 2000 was wrong, as were later choices that made it more accessible, in part because they neglected to consider safety risks to women. The FDA and Danco claim that severe side effects are “exceedingly rare.”
Following the Supreme Court’s ruling in April, the case has proceeded normally through the appellate process, with the 5th U.S. Circuit Court of Appeals in New Orleans last month upholding a portion of Kacsmaryk’s ruling regarding the actions the FDA took to relax restrictions on the pill, which includes making it available by mail. That led to Danco and the Biden administration turning once more to the Supreme Court.
The 5th Circuit ruling will be enforceable nationally if the justices decline to take the case. According to Prelogar, this “would upend the regulatory regime on mifepristone, with harmful consequences for women seeking legal abortions and a health care system that depends on the availability of the drug under current usage.”
In that case, there would be considerable restrictions on how people may acquire the pill. Women will have to make multiple journeys in person to a doctor’s office rather than being able to obtain it via mail anymore. Considering that the previous dosing schedule was altered in 2016, a greater dose of the drug will also be necessary.
According to a White House spokesman, if the 5th Circuit’s ruling were to become law, “it would have devastating implications for women and undermine the FDA’s process for overseeing medications that are secure and effective that patients rely on.”
The spokesman said, “This case poses an unprecedented threat to the FDA’s jurisdiction to examine and approve an extensive number of safe and effective pharmaceuticals. This concern has been made plain by the biopharma sector, physicians including medical organizations, former FDA as well as former DOJ officials, and patient advocates.
The Roe v. Wade decision, which established a constitutional right to abortion, was overturned by the Supreme Court in 2022, and the court now has a 6-3 conservative majority. However, the mifepristone litigation presents very different legal questions, and because of the court’s earlier intervention, the challengers may have an uphill battle to succeed.
The FDA-approved medication abortion protocol uses a combination of the progesterone-blocking medicine mifepristone and the contraction-inducing drug misoprostol. According to a study done by the Guttmacher Institute, a research organization that promotes abortion rights, these tablets are used for the majority of abortions in the U.S. Misoprostol accessibility was not at issue in the complaint