The Supreme Court put a halt Friday to lower court rulings that would have limited a commonly used abortion medication drug, maintaining access to mifepristone while the challenge to FDA approval moves through the court system.
The order means mifepristone will still be approved for abortion up to 10 weeks of pregnancy and be used at home with distribution by mail. A lower court ruling would have limited the Food and Drug Administration’s regulation of mifepristone, a drug used in the majority of abortions in the United States.
Only Justices Samuel A. Alito Jr. and Clarence Thomas noted that they would have allowed the lower court decision to take effect.
“Contrary to the impression that may be held by many, that disposition would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone,” Alito wrote in a dissent. “Rather, it would simply refuse to take a step that has not been shown as necessary to avoid the threat of any real harm during the presumably short period at issue.”
Alito also wrote that the FDA had not appealed a decision in a separate case against the agency in the Eastern District of Washington, where a district judge had paused changes to the regulation of the drug applicable to 17 states and the District of Columbia.
“The FDA did not appeal that appealable order, and when seven States that might take such an appeal asked to intervene, the FDA opposed their request. This series of events laid the foundation for the Government’s regulatory “chaos” argument,” he wrote.
President Joe Biden, in a statement, praised the action.
“As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” Biden said. “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.”
Alliance Defending Freedom, which represents the groups challenging FDA’s approval of mifepristone, called the move a “common practice.”
“Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts,” said ADF Senior Counsel Erik Baptist in a statement. “We look forward to a final outcome in this case that will hold the FDA accountable.”
Alito had originally issued a temporary stay on the case until Wednesday, but extended that until Friday, preventing changes to mifepristone.
FDA first approved mifepristone in 2000, and the drug is used in conjunction with another drug, misoprostol, for medication abortions up to seven weeks gestation and in miscarriage management. Mifepristone is more heavily regulated than most drugs through FDA’s risk safety program.
Since its approval, FDA has modified some of its initial regulations, approving a generic form of the drug in 2019. In 2016, FDA expanded the drug’s use to up to 10 weeks into pregnancy, allowing it to be prescribed by telehealth and by advanced practice practitioners.
In 2021, the agency gave the green light for mifepristone to be dispensed by mail, a decision that DOJ defended in 2022, arguing that it would not violate an 1873 law known as the Comstock Act.
Alito’s extension Wednesday came on the same day that GenBioPro, which manufactures the generic form of mifepristone, also filed suit against the FDA to prevent changes to prevent a court from blocking their drugs. Later Wednesday, Students for Life submitted a citizen petition to FDA requesting mifepristone’s approval be revoked.
Alito’s extension Wednesday came on the same day that GenBioPro, which manufactures the generic form of mifepristone, also filed suit against the FDA with the goal of preventing courts from blocking their drugs. Later Wednesday, meanwhile, Students for Life submitted a citizen petition to FDA requesting mifepristone’s approval be revoked.
Friday’s order comes after Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a ruling April 7 suspending the FDA’s original 2000 approval of mifepristone.
After the Justice Department appealed Kacsmaryk’s ruling, the U.S. Court of Appeals for the 5th Circuit issued a ruling on April 12 that would allow mifepristone made by Danco Laboratories to stay on the market but would temporarily pause FDA’s changes to its regulation since the 2000 approval.
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