Supreme Court delays decision in abortion drug case
Two-day punt keeps mifepristone at least temporarily available
The Supreme Court gave itself more time on a decision expected Wednesday about a commonly used abortion drug, extending until Friday a temporary pause on a lower court ruling that would restrict availability of mifepristone.
Justice Samuel A. Alito Jr. issued the brief order in the challenge to the Food and Drug Administration’s two-decade old approval of mifepristone, which is used in medication abortions, keeping the drug at least temporarily available for now.
The Supreme Court has paused a district court order that would suspend the FDA approval of the drug and an appeals court ruling restricting its availability. The Supreme Court decision in the case will come less than a year after the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned the constitutional right to an abortion.
Earlier this month, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a ruling that suspended the FDA’s original approval of mifepristone. That ruling was followed last week by a decision from the U.S. Court of Appeals for the 5th Circuit that would allow the drug to remain on the market but reinstate conditions the FDA changed in 2016 and 2021.
Both the Department and Justice and Danco, which manufactures mifepristone, asked the Supreme Court to intervene and Alito, who handles emergency applications from the 5th Circuit, issued a temporary stay through Wednesday. Alito extended that stay until Friday.
The FDA originally approved the drug as part of a two-drug regimen with misoprostol for medication abortion and miscarriage management. In 2016 and 2021 the agency revised rules for mifepristone, broadening when in pregnancy it could be used and removing in-person examination requirements.
The agency also decided in 2021 that the drug could be distributed through the mail and the Justice Department in 2022 said mail distribution did not violate federal criminal law, an assertion the challengers to the drug’s approval have disputed, citing an 1873 law.
Separately, a district court in Washington issued an order earlier this month mandating the FDA not alter availability of the drug in 17 states and the District of Columbia. The Justice Department has said it cannot comply with both orders.
In a reply brief filed Tuesday night, the Justice Department argued the lower courts’ rulings would have a “profoundly destabilizing” effect on abortion access and drug approvals more broadly.
Josh Sharfstein, former principal deputy commissioner of the FDA, said Tuesday that a decision that challenges the agency’s drug oversight “throws open the fundamental foundation of drug regulation.”
“I do think that we're going to see health departments, attorney generals' offices, governors' offices rolling up their sleeves, and trying to figure out in a number of states, what's the way to actually help patients so that people can be healthier in their state,” Sharfstein said.
The high-stakes case has attracted congressional attention as well as further litigation.
White House Press Secretary Karine Jean-Pierre, speaking during a Wednesday briefing, said that the president’s senior advisers will continue briefing him on the case as a “high priority” but would not elaborate on what actions the administration would take next.
FDA Commissioner Robert Califf faced questions about mifepristone during a Senate Agriculture Appropriations Subcommittee hearing on the agency’s budget Wednesday afternoon. It's unclear whether the FDA can use enforcement discretion to put the order on the back burner.
“I consider the FDA to be the gold standard globally in approving drugs, and I find this court ruling to be more reflective of the judge’s personal views rather than the fair and impartial analysis of the facts of the case,” said Sen. Susan Collins, R-Maine, one of two Senate Republicans who supports abortion rights.
Sen. Cindy Hyde-Smith, R-Miss., told Califf she agreed with the 5th Circuit’s decision.
“That’s what the lawsuit is about, not judging if the drug is safe or unsafe but that it failed, the FDA failed to meet its legal obligation to protect the safety of women and girls,” Hyde-Smith said.
Hyde-Smith also asked Califf if the FDA would allow the lower court to go into effect if instructed to be the Supreme Court.
“We are confident that the law is on our side,” Califf said. “FDA does intend to comply with any court orders.”
GenBioPro, the pharmaceutical company that manufactures generic mifepristone, filed a lawsuit Wednesday against the FDA, asking the U.S. District Court of Maryland to prevent the FDA from making changes to mifepristone’s availability. GenBioPro’s generic was approved in 2019, meaning the drug’s availability would be in jeopardy if the Supreme Court agrees with the 5th Circuit.
GenBioPro makes two-thirds of the mifepristone sold in the U.S., compared to Danco’s name brand version, which is known as Mifeprex.
The GenBioPro case is the third post-Dobbs that has challenged the FDA’s regulation of mifepristone.
A group of 253 congressional Democrats filed a brief in the mifepristone case Friday, arguing the court decisions destabilized the drug approval process and threatened abortion access nationwide.
On the Republican side, a group of 147 GOP lawmakers submitted a brief Tuesday in support of the lower court rulings, calling efforts to deregulate mifepristone "a dangerous game with the health and safety of women and girls."
The Senate Judiciary Committee scheduled a hearing for next Wednesday on the “fallout” nationwide since the Dobbs decision. In a statement announcing the hearing Wednesday, Sen. Richard J. Durbin, D-Ill., referred to the case as part of a broader effort to restrict abortion access.
“Republican-led legislatures have passed abortion bans in more than a dozen states, and now, a single federal judge in Texas has sought to upend our federal drug approval process,” Durbin’s statement said.
Lauren Clason contributed to this report.