The Supreme Court will hear the challenge to access to the abortion pill

The Supreme Court announced on Wednesday that would rule on the availability of a commonly used abortion pill, the first major abortion-related case on its docket since it struck down the constitutional right to the procedure more than a year ago.

The Biden administration had asked the justices to intervene after a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit favored curbing distribution of the drug mifepristone, appearing skeptical of the U.S. regulation of the pill. Food and Drug Administration in recent years. . In its ruling, the panel said the pill would remain legal, but with significant restrictions on patient access, including a ban on mailing the drug or prescribing it via telemedicine.

The move begins a high-stakes fight over the drug that could dramatically reduce access to the drug, even in states where abortion remains legal. It could also have implications for the regulatory authority of the Food and Drug Administration, which approved the pill more than two decades ago.

The Supreme Court is now in the unusual position of ruling on abortion access even after its conservative majority declared it would leave that issue to elected officials. Until the court issues a decision, the FDA’s approval of the drug remains in effect, delaying the possibility of abrupt limits on a drug used in more than half of all pregnancy terminations in the United States.

The Supreme Court has not set a date for the debate, but is expected to issue a decision at the end of its term in late June. That means a ruling could come in the heart of the campaign season, during which abortion is expected to be a centerpiece of Democratic platforms.

Abortion rights groups welcomed the court’s decision to hear the case.

“The stakes are high in post-Roe America,” Nancy Northup, president and CEO of the Center for Reproductive Rights, a legal advocacy organization, said in a statement.

Alliance Defending Freedom, the group representing those challenging the FDA’s authority, said in a statement that the court would help resolve whether “the FDA has harmed women’s health and undermined the rule of law by illegally eliminating all significant safeguards of the chemical. abortive drug regimen.”

Since the Supreme Court overturned Roe v. Wade in June 2022, the battle over abortion has largely played out in the states, where it remains a potent political and legal issue.

More than a dozen states have enacted bans or restrictions, and Democrats have used the ruling’s fallout to galvanize voters at the polls, even in conservative-leaning states. In Texas, a woman sought an emergency court order to undergo an abortion, but was ultimately denied by the state Supreme Court and left the state to undergo the procedure. And in Ohio, voters resoundingly approved a ballot measure enshrining abortion rights in its constitution in November. The success of similar campaigns has inspired efforts in Arizona, Florida, Nevada and Pennsylvania.

The justices had discussed the case at their Friday conference, the private meeting among the nine. They will hear two consolidated cases challenging the most recent changes the FDA made starting in 2016 to expand distribution of the drug, FDA v. Alliance for Hippocratic Medicine, No. 23-235, and Danco Laboratories v. Alliance for Hippocratic Medicine, No. 23 -236.

When asking the Supreme Court to hear the caseJustice Department lawyers described the appeals court ruling as unprecedented in questioning the FDA’s expert judgment. Such a decision, they added, “would threaten to seriously disrupt the pharmaceutical industry and prevent the FDA from fulfilling its legal responsibilities in accordance with its scientific judgment.”

Alliance Defending Freedom, a conservative Christian legal defense organization that has brought cases for clients who oppose abortion and gay and transgender rights, represents the opponents. in a shortThe group’s attorneys argued that the Supreme Court did not need to intervene and called the appeals court’s decision a “modest decision” that “simply restores the common-sense safeguards under which millions of women have taken chemical abortion medications.”

The tangled standoff over the future of the pill reflects how medical abortion has become the next big battlefront for conservative groups.

The case began in November of last year, when a group of anti-abortion medical organizations and some doctors filed a lawsuit describing the FDA approval as flawed and questioning the safety of the drug.

Many studies on mifepristone have shown that it is very safe and effective, and years of research have shown that serious complications are rare. Less than 1 percent of patients need hospitalization, medical experts have said.

The drug, the first of a two-part regimen, has been used by more than five million people in the United States and is approved for use in dozens of countries. Under the current FDA regulatory framework for mifepristone, it has been more strictly regulated and more intensively studied than most other medications.

The group filed its challenge in the Panhandle city of Amarillo, Texas, where only one federal judge is hearing civil lawsuits filed there: Judge Matthew J. Kacsmaryk, a Trump appointee who has long opposed abortion.

In April, Judge Kacsmaryk issued a preliminary ruling invalidating the FDA’s approval of the drug. Days later, a three-judge panel of the Fifth Circuit, based in New Orleans, overturned part of its ruling, allowing the drug to remain on the market but with restrictions.

The Justice Department was among those to ask the Supreme Court for emergency relief, which temporarily halted any changes to the drug’s availability while an appeal moved through lower courts.

A different panel of three Fifth Circuit judges ruled in August that the FDA’s original approval of mifepristone should stand, as should the approval of a generic version in 2019.

But it rolled back regulations governing the pill to before 2016. In the years since, the agency made changes that expanded access to the drug. Under those pre-2016 rules, mifepristone must only be prescribed by a doctor and picked up in person. The patients also had to visit the doctor three times during the abortion process.