Washington — Supreme Court Justice Samuel Alito on Friday put on hold a lower court decision in a dispute involving the Food and Drug Administration’s approval of the abortion pill mifepristone, preserving access to the drug for now.
Alito, who handles applications for emergency relief from the U.S. Court of Appeals for the 5th Circuit, granted a request from the Justice Department for an administrative stay, which preserves the status quo as the court considers its request to intervene in the court battle over mifepristone. Limits on how late into a pregnancy the drug can be taken, who can prescribe it and how it can be dispensed were set to take effect Saturday at 1 a.m.
Alito’s hold will stay in place until 11:59 p.m. Wednesday, and he gave anti-abortion medical associations and physicians who brought the challenge to the FDA’s approval of the drug until noon Tuesday to respond.
The Biden administration and the drug’s maker, Danco Laboratories, officially asked the Supreme Court on Friday to intervene and block an April 7 order from a federal district judge that halted the FDA’s 2000 approval of mifepristone and subsequent actions taken by the agency that made it easier to access.
Before arriving at the Supreme Court, the Justice Department swiftly appealed the lower court’s decision to the 5th Circuit and asked it to halt Kacsmaryk’s decision. Late Wednesday, the appeals court paused the part of the decision that halted the FDA’s approval of the mifepristone, but it left in place remaining portions of the order that blocked changes made by the FDA beginning in 2016, tightening rules surrounding the most common method of terminating an early pregnancy.
The changes made by the FDA regarding mifepristone included extending the gestational limit for the drug’s use from seven weeks to 10 weeks of pregnancy, reducing the number of required in-person clinic visits and broadening the set of health care providers allowed to prescribe the drug.
The FDA also approved a generic version of mifepristone in 2019 and lifted a requirement that the pills be dispensed in-person in 2021, which allowed the drug to be prescribed by a provider during telemedicine appointments and sent by mail.
The decision by the Biden administration to seek emergency relief from the Supreme Court was not unexpected — it said in filings to the 5th Circuit that it would turn to the high court if necessary — and is the latest move in its swift legal response to the decision from Kacsmaryk. President Biden has vowed to protect abortion access, and White House press secretary Karine Jean-Pierre told reporters the administration “will prevail because we believe that the law is on our side.”
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement Thursday, before the Justice Department formally made its request. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
The case, known as Alliance for Hippocratic Medicine v. FDA, is the most significant involving abortion rights to land before the Supreme Court since it ended the constitutional right to abortion by overturning Roe v. Wade last year. That decision paved the way for a dozen states to enact near-total bans on the procedure, while more have imposed new laws restricting the ability to obtain abortion care.
But the district court’s order and subsequent decision from the 5th Circuit conflict with a different ruling from a federal judge in Washington state. That decision ordered the FDA to maintain the status quo with regards to mifepristone’s availability in 16 states and the District of Columbia. Those states and D.C. sued the Biden administration in February over a set of restrictions imposed on the drug and sought to preserve access to it.
The competing orders only inject further chaos and confusion into a legal landscape upended by the Supreme Court’s reversal of Roe.
Referencing the turmoil that has followed the conflicting court orders regarding mifepristone, Danco said the “result is an untenable limbo, for Danco, for providers, for women, and for health care systems all trying to navigate these uncharted waters-and all after plaintiffs waited years and years before claiming irreparable injury and a need for an emergency injunction voiding the decades-long status quo.”
The challenge to mifepristone’s FDA approval is the latest effort from anti-abortion rights advocates to curtail abortion access. The lawsuit was brought by a conservative legal organization on behalf of the physicians and medical associations in federal court in Amarillo, Texas, where only Kacsmaryk hears cases.
Lawyers for the challengers argued the FDA erred in determining mifepristone’s safety and effectiveness, and claimed the agency exceeded its regulatory authority in approving the drug more than 20 years ago.
But the FDA has stressed that serious adverse events are exceedingly rare when mifepristone is used as the agency directs and noted that more than 5 million women have taken the medication since 2000. Only 28 deaths were reported through June 2022, some of which were associated with “obvious alternative causes” unrelated to use of the abortion pill, the agency said.
Medication abortions accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention. Mifepristone is taken together with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation.
With access to mifepristone at risk, Democratic-led states have moved to beef up their supplies of the drug and misoprostol, which can be taken on its own to terminate an early pregnancy. But a misoprostol-only medication abortion is slightly less effective — between 80% and 99% — than the two-drug regimen of mifepristone and misoprostol, which is between 95% and 99% effective.
California Gov. Gavin Newsom announced Monday that the state secured an emergency stockpile of up to 2 million misoprostol pills. Massachusetts Gov. Maura Healey directed health care providers in the state to bank more doses of mifepristone. The University of Massachusetts Amherst purchased roughly 15,000 doses, enough to last the state more than a year, and the doses are set to arrive this week. New York Gov. Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol.