The abortion drug mifepristone will remain available after the US Supreme Court blocked a lower court ruling from taking effect on Friday.
In a 7-2 vote, the court upheld a 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 in Friday’s decision.
The Supreme Court’s decision follows US District Judge Matthew Kaczmaryk’s decision on April 7 in Texas to revoke the Food and Drug Administration’s approval of mifepristone for use as an abortion treatment in 2000, effectively pulling it from the market. Before being nominated by President Donald Trump to the federal bench, Kaczmaryk served as counsel to anti-abortion organizations.
A panel of three judges in the 5th Circuit – two Trump nominees and a George W. Bush pick – scaled back the decision to sweep Kaczmaryk while still threatening the distribution of mifepristone. The two Trump-appointed judges who wrote the majority opinion for the court upheld the 2000 FDA approval for the drug, but revoked all FDA approval for the drug after 2016, including for the generic drug version, and FDA approval of telemedicine visits. for the prescription of the drug and for the delivery of the drug by mail on January 3.
Danco Laboratories, the company that makes mifepristone, and the US government appealed to the Supreme Court to overturn the appeals court’s decision. Alito put the ruling on hold until April 14 so the justices could consider the case.
Both the Justice Department and Danco argued in briefs to the court that the 5th Circuit’s decision would result in the entire drug mifepristone, which goes by the brand name Mifeprex, being pulled from the market because the FDA’s authorization code is no longer valid.
“Without a stay, the state’s order that has not yet come before the court will undermine the regulatory regime that governs drugs that the FDA has determined are safe and effective under approved conditions and have been used by more than five million American women over the past two decades,” the DOJ brief said. “Any remaining Mifeprex packages will be immediately invalidated and cannot be legally entered into interstate commerce.”
In addition, GenBioPro, the maker of generic mifepristone, and the DOJ said the 5th Circuit’s decision would pull all generic mifepristone from the market.
The Biden administration and abortion rights groups praised the court’s decision to keep the drug on the market.
“The stakes couldn’t be higher for women across America,” President Joe Biden said in a statement. “I will continue to fight the political attacks on women’s health. But let’s be clear – the American people must continue to use their voice as a voice, and vote for a Congress that will pass legislation that restores the protections of Roe v Wade.
Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement: “The Supreme Court decision is a big relief, but we’re not out of the woods yet. Now, providers and patients have the assurance that mifepristone is available and remains an FDA-approved drug. But we it should not be here.This case should be thrown out before it reaches the Supreme Court.
The manufacturer of mifepristone also issued a statement praising the decision.
“As we noted in our friend of the court filing last week, the Texas order has no basis in law or fact,” GenBioPro CEO Evan Masingill said in a statement. “We are asking the Fifth Circuit to vacate the order because this case is on appeal.”
In a snide solo dissent, Alito criticized fellow justices for previously criticizing the use of “shadow dockets” to judge cases when they were also used in this case. He added that he would not block the 5th Circuit’s decision because Danco and the Justice Department had not proven that anyone would be harmed.
“Currently, the applicants are not entitled to a stay because they have not shown that they will suffer irreparable harm during the interim,” Alito wrote.
He also asserted that the decision should not be blocked because the Biden administration “has not removed a legitimate doubt that it will follow an inappropriate order in this case, much less that it will choose an enforcement action that has strong objections.”
The mifepristone case is the first major ruling from the court since a conservative majority ended abortion rights by overturning the 1973 decision in Roe v. Wade in his 2022 ruling in Dobbs v. Jackson Women’s Health Organization.