The abortion drug mifepristone will remain widely available after the U.S. Supreme Court blocked lower court decisions from going into effect on Friday.
In a 7-2 vote, the court stayed the decision by a three-judge panel of the U.S. Court of Appeals for the 5th Circuit that limited access to mifepristone while the entire appeals court considered the case. Justices Samuel Alito and Clarence Thomas dissented from Friday’s decision.
The Supreme Court’s decision came after U.S. District Judge Matthew Kaczmaryk’s April 7 decision in Texas voided the Food and Drug Administration’s approval of mifepristone to be used as an abortion treatment in 2000, effectively withdrawing it from the market. Prior to being nominated by President Donald Trump to the federal bench, Kaczmaryk served as counsel for an anti-abortion organization.
A panel of three judges on the 5th Circuit ― two Trump nominees and a George W. Bush pick ― scaled back Kaczmaryk’s sweeping decision while still threatening the distribution of mifepristone. The two Trump-nominated judges who wrote the majority opinion for the court let the 2000 FDA approval of the drug stand but overrode all FDA approvals for the drug after 2016, including for the generic version of the drug, and the FDA’s approval of telemedicine visits for prescribing the drug and for shipment of the drug by mail on Jan. 3.
Danco Laboratories, the company that manufactures mifepristone, and the U.S. government appealed to the Supreme Court to rule on the appeals court decision. Alito put a hold on the decision on April 14 so that the justices could consider the case.
Both the Department of Justice and Danco argued in briefs to the court that the 5th Circuit’s decision would lead to all mifepristone drugs, which go by the brand name Mifeprex, being pulled from the market as their FDA authorization code would no longer be valid.
“Absent a stay, the lower courts’ unprecedented nationwide orders would scramble the regulatory regime governing a drug that FDA determined was safe and effective under the approved conditions and that has been used by more than five million American women over the last two decades,” the DOJ brief said. “Every extant package of Mifeprex would instantly become misbranded and could not be lawfully introduced into interstate commerce.”
Similarly, GenBioPro, the maker of generic mifepristone, and the DOJ argued that the 5th Circuit’s decision would pull all generic mifepristone from the market.
The Biden administration and abortion rights groups praised the decision by the court to allow the drugs to remain on the market.
“The stakes could not be higher for women across America,” President Joe Biden said in a statement. “I will continue to fight politically-driven attacks on women’s health. But let’s be clear ― the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade.”
Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement: “The Supreme Court’s decision is a huge relief, but we’re not out of the woods yet. For now, providers and patients have the assurance that mifepristone is available and remains an FDA approved drug. But we shouldn’t even be here. This case should have been thrown out way before it got to the Supreme Court.”
The makers of mifepristone also issued statements praising the decision.
“As we noted in our friend of the court brief filed last week, the Texas order has no basis in law or fact,” GenBioPro CEO Evan Masingill said in a statement. “We urge the Fifth Circuit to overturn the order as this case goes to an appeal.”
In a snide solo dissent, Alito criticized his fellow justices for previously criticizing the use of the “shadow docket” to judge cases while also using it in this case. He added that he would not block the 5th Circuit’s decision because Danco and the Justice Department had not proved that anyone would suffer harm.
“At present, the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim,” Alito wrote.
He also argued that the decision should not be blocked because the Biden administration “has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections.”
The mifepristone case was the first major decision from the court since its conservative supermajority ended the right to an abortion by overturning the 1973 decision in Roe v. Wade in its 2022 ruling in Dobbs v. Jackson Women’s Health Organization.