Supreme Court Lets Abortion Pill Remain on Market, for Now

Justice Department had asked high court to preserve access to widely used abortion pill

The Supreme Court temporarily blocked lower court orders that would have limited access to the abortion drug mifepristone beginning Saturday, preserving the pill’s availability while the justices weigh the Biden administration’s emergency request to leave current Food and Drug Administration approvals in place during a continuing legal battle with antiabortion groups.

In a pair of orders Friday, Justice Samuel Alito, who oversees emergency matters for the lower courts that limited or suspended approval of the widely used abortion pill, gave the antiabortion groups until noon Tuesday to file briefs in response to appeals by the FDA and Danco Laboratories LLC, which makes the branded version Mifeprex.

The temporary orders expire at 11:59 p.m. Wednesday, suggesting a high court decision on whether and to what extent mifepristone will remain available during litigation may come by then.

Antiabortion plaintiffs are challenging both the FDA’s 2000 approval of mifepristone and subsequent regulations starting in 2016 that relaxed the stringent conditions for the drug’s administration, such as a requirement for three in-person doctor visits.

A late Wednesday order from the Fifth U.S. Circuit Court of Appeals in New Orleans rolled back mifepristone access to the pre-2016 regulations, which limited its use to women pregnant for seven or fewer weeks, required three in-person doctor visits to receive and barred sending to patients through the mail.

That decision partially blocked an opinion the previous Friday by a federal district judge in Amarillo, Texas, Matthew Kacsmaryk, that would take the drug off the market by suspending its 2000 FDA approval.

Under current regulations, including some adopted during the coronavirus pandemic, mifepristone has been available to women up to 10 weeks pregnant, and they have been able to obtain prescriptions through telehealth appointments and have the medication sent by mail. By 2020, more than half of U.S. abortions were done with medication, according to the Guttmacher Institute, a research organization that supports abortion rights. Mifepristone also has other uses, including for miscarriage management.

In the Biden administration’s emergency appeal, U.S. Solicitor General Elizabeth Prelogar said the lower-court orders “would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.”

Danco Laboratories in its petition said the lower-court rulings created “debilitating uncertainty for Danco that threatens its very existence.”

Both filings pointed to a risk that sales of the pill could cease altogether in the coming days if the high court didn’t at least put a pause on the lower-court orders.

An antiabortion lawsuit challenging mifepristone’s approval should have been thrown out at the outset, the government said, because the plaintiffs’ objection to the drug is based on opposition to abortion, not any harm they personally have suffered from its approval decades ago. The challengers, although they include doctors, “neither take nor prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything,” the government said.

The mifepristone case is the latest aftershock of the Supreme Court’s 2022 decision rescinding abortion rights the justices had recognized in 1973. In overturning Roe v. Wade, which set out women’s constitutional right to end pregnancy before fetal viability, the court said it was ending a 49-year effort to impose a nationwide settlement on a divisive question of public policy and personal morality.

“We do not pretend to know how our political system or society will respond to today’s decision,” Justice Alito wrote for the majority in Dobbs v. Jackson Women’s Health Organization, but whatever that may be, “the authority to regulate abortion must be returned to the people and their elected representatives.”

Dobbs’s political impact was immediate, energizing both sides of the abortion debate. With a majority of Americans supporting access to the procedure, the Democratic Party’s commitment to abortion rights has been boosting its performance at the ballot box, retaining a majority in the U.S. Senate last November and seeing liberals take a 4-3 majority on the Wisconsin Supreme Court after this month’s state election.

In the South and other areas where antiabortion views are more widespread, opponents of the procedure have redoubled efforts to restrict access. On Thursday, Florida’s Republican-controlled legislature sent GOP Gov. Ron DeSantis a bill prohibiting women from obtaining abortions after six weeks of pregnancy, which he signed hours later.

But if the Supreme Court thought it had washed its hands of the issue, the mifepristone case demonstrates that litigation will remain a central arena where abortion rights are contested.

The lawsuit, Alliance for Hippocratic Medicine v. FDA, was filed in November by a group of antiabortion doctors and healthcare organizations who allege the government’s 2000 approval of mifepristone was so flawed that it must be voided now. Although they don’t prescribe mifepristone themselves, they argued that the drug’s approval in 2000 put them at risk of having to treat a patient who might suffer complications from its use.

By filing in Amarillo, the plaintiffs guaranteed that Judge Kacsmaryk, a Trump appointee who once worked for conservative Christian litigation group First Liberty Institute, would hear the case; he is the only district judge in the city’s federal courthouse.

Judge Kacsmaryk’s 67-page decision, which said that mifepristone cannot have therapeutic benefit because pregnancy isn’t an illness, was to take effect Friday absent appellate court intervention.

Almost immediately afterward, a federal judge in Spokane, Wash., Obama appointee Thomas Rice, issued an opinion at odds with the Amarillo order, preventing the FDA from changing access to mifepristone in the 17 states and the District of Columbia that had filed a suit arguing that current regulations on the drug’s dispersal were more restrictive than federal law allows.

Judge Rice clarified and reaffirmed his order Thursday, saying the agency had to abide by his ruling irrespective of the rulings in Texas and the Fifth Circuit.

Wednesday’s decision from a divided three-judge panel of the Fifth Circuit found it was likely too late to contest the 2000 approval but left intact Judge Kacsmaryk’s injunction of subsequent changes in regulations while litigation proceeded.

“We look forward to explaining why the FDA has not met its heavy burden to pause the parts of the district court’s decision that restore the critical safeguards for women and girls that were unlawfully removed by the FDA,” said Erin Hawley, a lawyer with Alliance Defending Freedom, an advocacy group which represents the plaintiffs.