WASHINGTON — The U.S. Supreme Court announced Wednesday it will hear oral arguments and decide whether broad access to the abortion pill can remain legal throughout the United States.
Judges decision to consider the case This term will bring the issue of abortion access and related policy issues back to the nation’s highest court just before the 2024 presidential election.
The drug at the center of the case, mifepristone, is used in more than half of pregnancy terminations in the United States as part of a dual-drug regimen that includes misoprostol as a second drug. Both are also used to treat miscarriages.
Patient access to mifepristone cannot change until the Supreme Court issues a ruling, according to an order issued earlier this year.
The nine-member court will address three questions in its ruling, including whether changes the U.S. Food and Drug Administration made to prescribing and dosing rules in 2016 and 2021 were “arbitrary and capricious.” Those changes, which expanded access, included mailing the abortion pill to patients.
The Supreme Court will also decide whether a federal district court judge who ruled earlier this year to overturn the FDA’s initial 2000 decision to approve the drug “properly granted interim relief.”
Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a written statement that the Supreme Court “has never overturned long-standing FDA approval, as is now required.”
“The stakes are enormous in post-Roe America,” Northup said. “Even those who live in states with strong abortion rights protections could find their ability to access mifepristone severely limited if the Court rules against the FDA.”
Northup said the ability for health care providers to prescribe medications via telemedicine and deliver them to patients in their homes became “critical” after the court last year struck down the constitutional right to abortion.
“Abortion pills have been used safely in the United States for over 20 years, and they are more important than ever in this post-Roe landscape,” Northup said. “That’s why the anti-abortion movement is attacking them.”
Alliance Defending Freedom senior counsel Erin Hawley said in a written statement that the anti-abortion organization is calling on the Supreme Court to find “that the FDA acted unlawfully in removing reasonable protections for women and authorizing unsafe mail-order abortions.”
“Like any federal agency, the FDA must rationally justify its decisions,” Hawley said. “However, its removal of common-sense safeguards — such as seeing a doctor before prescribing chemical abortifacient drugs to women — reflects not scientific judgment but rather a politically motivated decision to push an unsafe regimen.”
The constitutional right to abortion has been repealed
The nine Supreme Court justices who will hear the case and ultimately issue a ruling are the same judges who repealed the constitutional right to abortion in the ruling of June 2022.
In majority opinion In that case, Dobbs v. Jackson Women’s Health Organization, the conservative justices wrote that “the power to regulate abortion returns to the people and their elected representatives.”
Following the decision, states across the country began implementing laws of their own choosing, with some placing significant restrictions on when abortion is legal and other states taking steps to expand access to it.
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Several states have banned legal access to mifepristone, the abortion pill, even though it is an FDA-approved drug.
In mid-November 2022, the Alliance in Defense of Freedom filed a lawsuit questioning the original approval of the abortion pill in 2000, as well as changes to when and how the drug can be used made in 2016 and during the COVID-19 pandemic.
The lawsuit was filed on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations, as well as four physicians from California, Indiana, Michigan and Texas.
United States District Court for the Northern District of Texas Judge Matthew Joseph Kacsmaryk ruled in April 2023. that mifepristone should be pulled from sale altogether, though he wrote that he “does not question the FDA’s decision lightly.”
“However, in this case, the FDA acquiesced to its legitimate safety concerns — in violation of its statutory duty — by relying on patently flawed reasoning and studies that did not support its conclusions,” Kacsmaryk wrote.
The Biden administration asked for a stay of the ruling while the case is appealed, which was granted the Supreme Court finally admitted. The judges’ abstention ensured that mifepristone would remain legal until the ruling was made.
5th Circuit Ruling
The case went to the Fifth Circuit Court of Appeals in New Orleans, Louisiana, which I heard the arguments in May 2023
Panel of three judges he ruled in August 2023, it was stated that the abortion pill should remain available nationwide, but the dosage and method of utilize should return to the state prior to the FDA’s 2016 changes.
The ruling was immediately stayed pending an appeal to the Supreme Court. If the justices had decided not to hear the appeal, the ruling would have gone into effect.
A return to pre-2016 regulations would prevent mifepristone from being prescribed via teleconsultation or sent by post.
Only physicians will be able to prescribe mifepristone, which will prevent other healthcare professionals from prescribing this particular medication.
Prescriptions could only be written for up to seven weeks of pregnancy, which is shorter than the 10 weeks currently used by prescribers.
Patients would need to make three in-person visits to a doctor to receive a medication abortion. The dosage and timing of mifepristone, as well as the second drug, misoprostol, would revert to what they were using more than seven years ago.
Justice Department Appeal
Following a ruling by the 5th Circuit Court of Appeals, the U.S. Department of Justice appealed against this ruling to the Supreme Courtarguing that the two lower courts made “serious legal errors.”
“Losing access to mifepristone would be detrimental to women and health care providers nationwide,” the Justice Department wrote in a 42-page document. “For many patients, mifepristone is the best option for legally terminating an early pregnancy. They may choose mifepristone over surgical abortion based on medical necessity, privacy concerns, or past trauma.”
“Surgical abortion is an invasive medical procedure that may pose greater health risks to some patients, such as those who are allergic to anesthesia,” the Justice Department added.
Multiple medical organizations have filed briefs with the district court, the court of appeals, or both, arguing that scientific research supports the utilize of mifepristone for medical abortion up to 10 weeks of pregnancy.
More than a dozen medical groups, including the American College of Obstetricians and Gynecologists, the American Medical Association and the Society for Maternal-Fetal Medicine, wrote in a 48-page report miniature concluded on appeal that “the overwhelming preponderance of scientific evidence supports the FDA’s determination that mifepristone is safe and effective.”
“Mifepristone is one of the most studied prescription medications in the United States, and its safety profile is comparable to ibuprofen,” they wrote.
Medical organizations have written that “denying or restricting access to mifepristone will not make patients safer — on the contrary, it will actively endanger their health.”
“Pregnancy can be dangerous,” they wrote. “The risk of maternal mortality in the United States is alarmingly high, and dramatically higher for black women, poor women, and all those whose access to reproductive care has been historically and geographically limited.”
White House, Congressional Response
White House press secretary Karine Jean-Pierre said in a written statement released Wednesday after the Supreme Court announced it would take up the case that the Biden administration “will continue to uphold the FDA’s independent approval and regulation of mifepristone as safe and effective.”
“Across the country, we have witnessed unprecedented attacks on women’s freedom to make their own health care decisions,” said Jean Pierre. “States have enacted extreme and dangerous abortion bans that threaten to endanger women’s health and threaten to criminalize doctors for providing the health care their patients need and are trained to provide.”
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Washington state Sen. Patty Murray, a Democrat, said in a written statement Wednesday that “this matter has nothing to do with the safety or effectiveness of FDA-approved mifepristone — which is not up for debate — but with Republicans’ anti-woman, anti-science, anti-abortion agenda that they continue to impose on the American people despite repeated and overwhelming rejections at the polls and in the court of public opinion.”
“Beyond the truly devastating harm this case would do to women’s access to essential health care — at a time when medication abortion accounts for more than half of all abortions in the U.S. — the implications for other FDA-approved medications that Americans rely on are profound,” Murray said. “It is imperative that the Supreme Court reverse the Fifth Circuit’s ruling and once and for all reject plaintiffs’ outrageous, politically motivated efforts to drastically restrict access to essential and life-saving abortion care nationwide.”
Update: This article was updated on December 13, 2023 at 11:54 a.m. with additional details.
