Supreme Court orders mifepristone to remain available pending lower court appeals

The Supreme Court voted 7-2 to keep the abortion pill mifepristone broadly available as the legal battle over its Food and Drug Administration approval status plays out in the lower courts, according to a Friday evening decision.

Justice Samuel Alito and Justice Clarence Thomas opposed the decision.

In a dissenting opinion, Alito wrote that allowing an appellate court’s narrowed stay “would not remove mifepristone from the market. It would simply restore the circumstances that existed (and that the government defended) from 2000 to 2016 under three presidential administrations.”

He wrote that the Biden administration and the drug’s manufacturer’s applications for the stay did not show “that they are likely to suffer irreparable harm in the interim” and downplayed arguments that the decision would sow “regulatory ‘chaos.’”

Alito also said that Danco, the drug’s manufacturer, would not be harmed unless the FDA invoked its enforcement discretion, “and the applicants’ papers do not provide any reason to believe the FDA would make that choice,” he wrote.

No other justices commented on the decision to uphold the stay.

The Supreme Court’s decision is a victory for the White House, which has worked to maintain access to abortion drugs and services since the Supreme Court overturned Roe v. Wade last year.

“I continue to stand by FDA’s evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” President Joe Biden said in a statement from the White House.

The top court’s highly anticipated order stems from a U.S. District Court for the Northern District of Texas judge’s order regarding a lawsuit brought by anti-abortion provider group Alliance for Hippocratic Medicine.

U.S. District Judge Matthew Kacsmaryk ruled that the Food and Drug Administration had improperly approved the drug when the agency made changes to its risk evaluation and management strategy (REMS) and later denied citizen petition. The lower court stayed its suspension of the drug approval for a week to give the Biden administration time to appeal.

The Fifth Circuit Court of Appeals subsequently ruled that mifepristone could stay on the market but, due to the FDA’s REMS changes, could no longer be sent by mail. The divided three-judge panel also prohibited non-doctor providers from prescribing the drug and reduced its use from a 70-day gestation window to a 50-day gestation window.

Another appeal from the Biden administration escalated the case to the Supreme Court. On April 14, Justice Samuel Alito issued an emergency ruling that stayed the appellate court’s decision (which was later extended by two days) in order to consider amicus filings from stakeholders including drugmakers, the Department of Justice, providers, states, lawmakers and anti-abortion advocates.

Also complicating matters is a Washington federal court judge’s order that prevents changes to the regulation and approval of mifepristone, though that only applied to 17 states and the District of Columbia.

In filings with the top court, mifepristone maker Danco argued that the lower court’s restrictions and the conflicting order would cause “untenable limbo” for the healthcare industry and leave many providers in legal gray areas.

The DoJ wrote in its application for a stay that the “unprecedented’ decision revoked the FDA’s scientific judgement and would unleash “regulatory chaos.” The department also said that the unintended health consequences of mifepristone, which the district and appellate courts said give plaintiffs standing, are “exceedingly rate” when the drug is taken in accordance with its approval.

"The district court countermanded a scientific judgment FDA has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies," the DOJ wrote to Justice Samuel Alito.

More than half of abortions in the U.S. rely on mifepristone. Prescriptions for it and misoprosotol, another abortion-inducing drug, have increased following the Supreme Court’s decision to overturn Roe v. Wade and recent restrictions in several states.

Friday's decision was quickly applauded by healthcare and pharmaceutical industry groups.

PhRMA, which represents the biopharmaceutical industry, described the Supreme Court's order as "a welcome step" toward maintaining the FDA's regulatory authority.

"As we’ve said previously and explained in our amicus brief, Congress gave the FDA the authority to determine whether a medicine is safe and effective for patients to use," Jim Stansel, PhRMA's regulatory and legal lead, said in a statement. "Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians. We will remain engaged to help ensure the concerns of our members are heard as the legal process unfolds.” 

Labor group National Nurses United said the decision reaffirmed its position that abortion is both healthcare and a human right. 

“The June 2022 overturn of Roe v. Wade represents one of the largest, if not the largest, takeaway of health care services in years," NNU President Jean Ross said in a statement. "So, we believe the Supreme Court’s decision today is a boon to resisting the ongoing, nationwide attacks on health care for vulnerable patients.”