by Jennifer Shutt, Georgia Recorder [This article first appeared in the Georgia Recorder, republished with permission]

December 13, 2023

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 across the United States.

The justices’ decision to hear the case this term will put abortion access and the politics that comes with it back in front of the nation’s highest court just before voters head to the polls for the 2024 presidential election.

The drug at the center of the case, mifepristone, is used in more than half of pregnancy terminations within the United States as part of a two-pharmaceutical regimen that includes misoprostol as the second medication. Both are also used in miscarriage treatment.

Patients’ ability to access mifepristone cannot change until the Supreme Court issues its ruling, under an order the court put out earlier this year.

The nine members of the court will be answering three questions in their ruling, including whether changes the U.S. Food and Drug Administration made to prescribing and dosage in 2016 and 2021 were “arbitrary and capricious.” Those changes that expanded access included shipping the abortion pill to patients through the mail.

The Supreme Court will also decide if the federal district court judge who ruled earlier this year to overturn the FDA’s original 2000 approval of the pharmaceutical “properly granted preliminary relief.”

Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a written statement the Supreme Court “has never invalidated a long-standing FDA approval like they are being asked to do here.”

“The stakes are enormous in post-Roe America,” Northup said. “Even those living in states with strong protections for abortion rights could have their ability to access mifepristone severely restricted if the Court rules against the FDA.”

Northup said the ability for health care providers to prescribe the medication through telehealth and for patients to get it delivered to their homes became “critical” after the court ended the constitutional right to an abortion last year.

“Abortion pills have been used safely in the U.S. for more than 20 years, and they are more important than ever in this post-Roe landscape,” Northup said. “That is precisely why the anti-abortion movement is attacking them.”

Alliance Defending Freedom Senior Counsel Erin Hawley said in a written statement the anti-abortion organization urged the Supreme Court to determine “that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions.”

“Like any federal agency, the FDA must rationally explain its decisions,” Hawley said. “Yet its removal of common-sense safeguards — like a doctor’s visit before women are prescribed chemical abortion drugs — does not reflect scientific judgment but rather a politically driven decision to push a dangerous drug regimen.”

Constitutional right to abortion overturned

The nine Supreme Court justices who will hear the case and ultimately render a ruling are the same justices who overturned the constitutional right to abortion in a June 2022 ruling.

In the majority opinion in that case, Dobbs v. Jackson Women’s Health Organization, the conservative justices wrote that “the authority to regulate abortion is returned to the people and their elected representatives.”

Following that decision, states throughout the country began to implement laws of their choosing, with some setting significant restrictions on when abortion is legal and other states moving to expand access.

Several states have prohibited legal access to the abortion pill mifepristone, despite it being an FDA-approved pharmaceutical.

In mid-November 2022, Alliance Defending Freedom filed a lawsuit challenging the original approval of the abortion pill in 2000 as well as the changes to when and how the drug could be used that were 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 doctors from California, Indiana, Michigan and Texas.

U.S. District Court for the Northern District of Texas Judge Matthew Joseph Kacsmaryk ruled in April 2023 that mifepristone should be removed from the market entirely, though he wrote that he did “not second-guess FDA’s decision-making lightly.”

“But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions,” Kacsmaryk wrote.

The Biden administration requested the ruling be placed on hold until it could appeal the case, which was ultimately granted by the Supreme Court. That stay from the justices ensured mifepristone remains legal until they issue a ruling.

5th Circuit ruling

The case went before the 5th Circuit Court of Appeals in New Orleans, Louisiana, which heard arguments in May 2023.

The three-judge panel ruled in August 2023 that it believed the abortion pill should stay available nationwide, but that dosage and use should revert to what was in place before the FDA began implementing changes in 2016.

That ruling was immediately placed on hold pending an appeal to the Supreme Court. Had the justices decided not to hear the appeal, that ruling would have taken effect.

Going back to what was in place before 2016 would prevent mifepristone from being prescribed during a telehealth appointment or sent through the mail.

Only doctors would be able to prescribe mifepristone, removing the option for other healthcare providers with the ability to prescribe medication from being able to do so with that particular drug.

Prescriptions could only be written for up to seven weeks gestation, less than the 10-week threshold currently used by prescribers.

Patients would need to attend three in-person doctor’s office appointments in order to receive a medication abortion. The dosage and timing of mifepristone as well as the second drug, misoprostol, would both revert to what was used more than seven years ago.

DOJ appeal

Following the 5th Circuit’s ruling, the U.S. Justice Department appealed its ruling to the Supreme Court, arguing the two lower courts made “serious legal errors.”

“The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation,” the DOJ wrote in the 42-page document. “For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma.”

“Surgical abortion is an invasive medical procedure that can have greater health risks for some patients, such as those who are allergic to anesthesia,” DOJ added.

Numerous medical organizations have filed briefs to either the district court or the appeals court or both, arguing that science supports the use of mifepristone for medication abortion up to 10 weeks.

More than a dozen medical groups — including American College of Obstetricians and Gynecologists, American Medical Association and Society for Maternal-Fetal Medicine — wrote in a 48-page brief filed in the appeals case that the “overwhelming weight of the scientific evidence supports the FDA’s finding that mifepristone is safe and effective.”

“Mifepristone is one of the most studied medications prescribed in the U.S. and has a safety profile comparable to ibuprofen,” they wrote.

The medical organizations wrote that “denying or limiting access to mifepristone will not make patients safer — it will actively jeopardize their health.”

“Pregnancy can be dangerous,” they wrote. “The risks of maternal mortality in the U.S. are alarmingly high and drastically higher for Black women, poor women, and all those whose access to reproductive care has been historically and geographically limited.”

White House, congressional reaction

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 stand by FDA’s independent approval and regulation of mifepristone as safe and effective.”

“Across the country, we’ve seen unprecedented attacks on women’s freedom to make their own health decisions,” Jean Pierre said. “States have imposed extreme and dangerous abortion bans that put the health of women in jeopardy and that threaten to criminalize doctors for providing the health care that their patients need and that they are trained to provide.”

Washington state Democratic Sen. Patty Murray said in a written statement Wednesday the “case has nothing to do with the safety or efficacy of FDA-approved mifepristone — which is not up for debate — but about Republicans’ anti-women, anti-science, and anti-abortion agenda which they continue to force on the American people despite repeated and overwhelming rejection at the ballot box 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 where medication abortion accounts for more than half of abortions in the U.S. — the implications for other FDA-approved medications that Americans rely on are enormous,” Murray said. “It is essential that the Supreme Court overturn the Fifth Circuit’s ruling and definitively reject the plaintiffs’ outrageous, politically motivated efforts to drastically restrict access to necessary and lifesaving abortion care throughout the entire country.”

Georgia Recorder is part of States Newsroom, a network of news bureaus supported by grants and a coalition of donors as a 501c(3) public charity. Georgia Recorder maintains editorial independence. Contact Editor John McCosh for questions: info@georgiarecorder.com. Follow Georgia Recorder on Facebook and Twitter.