The Supreme Court announced Wednesday that he would decide the availability of a commonly used abortion pill, the first major case involving abortion on his docket since he overturned 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 ruled in favor of limiting the distribution of the drug, mifepristone, appearing skeptical of the Food and Drug Administration’s regulation of the pill in recent years. . In its decision, the committee said the pill would remain legal, but with significant restrictions on patient access, including a ban on sending the drug by mail or prescribing it via telemedicine.
The move sets off a high-stakes fight over the drug that could significantly reduce access to the drug, even in states where abortion remains legal. It could also have implications for regulatory authority the Food and Drug Administration, which approved the pill more than two decades ago.
The Supreme Court now finds itself in the unusual position of ruling on abortion access, even after its conservative majority said it would leave the issue to elected officials. Until the court issues a ruling, the FDA’s approval of the drug remains in effect, delaying the risk of abrupt limits on a drug used in more than half of all terminations of pregnancies in the United States .
The Supreme Court has not set a date for the debates but is expected to issue its decision by the end of its term at the end of June. That means a decision could come at the heart of the election campaign in which abortion is expected to be the centerpiece of the Democratic agenda.
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 rights organization, said in a statement.
Alliance Defending Freedom, the group that represents those challenging the FDA’s authority, said in a statement that the court would help determine whether “the FDA has harmed women’s health and undermined the rule of law by suppressing illegally any meaningful warranty of the chemical.” abortifacient 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 an important political and legal issue.
More than a dozen states have passed bans or restrictions, and Democrats have used the fallout from the move to galvanize voters to the polls, even in conservative-leaning states. In Texas, a woman sought an emergency court order to have an abortion, but the state Supreme Court ultimately denied her the order and left the state to undergo the procedure. And in Ohio, voters largely approved a ballot measure in November that enshrines the right to abortion in its constitution. The success of similar campaigns has inspired efforts in Arizona, Florida, Nevada and Pennsylvania.
The justices had discussed the case during their Friday conference, the private meeting among the nine. They will hear two consolidated cases challenging more 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.
While asking the Supreme Court to hear the caseJustice Department lawyers called the appeals court’s decision unprecedented in that it called into question the FDA’s expert judgment. Such a move, they added, “would threaten serious disruption to the pharmaceutical industry and prevent the FDA from discharging its legal responsibilities consistent with its statutory obligations.” scientific judgment. »
Alliance Defending Freedom, a conservative Christian advocacy organization that has filed lawsuits for clients opposed to abortion and gay and transgender rights, represents the challengers. In shortlawyers for the group argued that the Supreme Court did not need to intervene, calling the appeals court’s ruling a “modest decision” that “simply restores the common-sense safeguards under which millions of women took chemical drugs to abort.”
The complex confrontation over the future of the pill shows how medical abortion has become the next major battle front for conservative groups.
The case began in November last year, when an umbrella group of anti-abortion medical organizations and a few doctors filed a lawsuit calling the FDA approval flawed and questioning the drug’s safety .
Many studies of 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 require hospitalization, according to medical experts.
The drug, the first in 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 studied more rigorously than most other drugs.
The group filed its challenge in the Panhandle town of Amarillo, Texas, where only one federal judge is hearing the civil suits filed there, Judge Matthew J. Kacsmaryk, a Trump appointee and longtime opponent of the 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 New Orleans-based Fifth Circuit reversed part of its decision, allowing the drug to remain on the market but with restrictions.
The Justice Department was among those seeking emergency relief from the Supreme Court, which temporarily suspended any changes to the drug’s availability while an appeal was pending in lower courts.
Another three-judge Fifth Circuit panel ruled in August that the FDA’s initial approval of mifepristone should remain in place, as should its approval of a generic version in 2019.
But it repealed regulations governing the pill, down to those before 2016. In the years since, the agency has made changes that have expanded access to the drug. Under these pre-2016 rules, mifepristone must only be prescribed by a doctor and collected in person. Patients were also required to see a doctor three times during the abortion process.
