Justice Samuel Alito, a George W. Bush appointee, extended the order until 11:59 p.m. Washington time on April 21. The order had been set to expire on April 19.
Alito didn’t provide a reason for the temporary extension, which keeps in place a stay on restrictions ordered by lower courts.
A district court judge ruled earlier this month that the U.S. Food and Drug Administration (FDA) appeared to violate its legal duty to evaluate a drug’s safety when it approved mifepristone, the abortion pill, in 2022. The judge ordered a pause on the FDA’s approval.
An appeals court panel said the ruling was too broad but kept in place the part that rolled back actions the FDA took in 2016 and more recently that loosened restrictions on mifepristone, including the action that enabled dispensation by mail. The panel found the government hadn’t proven the FDA’s actions “were not arbitrary and capricious.”
That prompted the U.S. Department of Justice and Danco Laboratories, which makes the pill, to ask the nation’s top court to step in.
Absent an emergency stay, mifepristone wouldn’t be available for some time, likely months, government lawyers and attorneys representing Danco told the court. The revision to pre-2016 standards would mean widespread changes, including alterations to product labels and promotional materials, they said.
Once the changes were made, fresh changes might be needed if certain updates to the rulings had been handed down.
The Alliance for Hippocratic Medicine, which brought the case, said blocking the earlier rulings would endanger women because mifepristone isn’t safe, and would lead to doctors having to deal with women harmed by the drug.
Alito temporarily stayed the lower court rulings on April 14. He entered the stay and the extension because he oversees the U.S. Court of Appeals for the 5th Circuit. Each justice handles emergency requests from one or more appeals courts.
Alito can ultimately decide whether to reject or approve the applications for an emergency stay or refer them to the full court. If he does the latter, at least five justices would need to approve an application.
Some lawmakers and abortion advocates have proposed ignoring any court orders restricting access to mifepristone, while others have said orders should be followed.
Flurry of Filings
Since Alito’s stay, multiple filings have urged the high court to side with one party or another.The American College of Obstetricians and Gynecologists and other public health groups, for instance, say that mifepristone has been thoroughly studied and is safe, and limiting access would “harm pregnant patients and have severe negative impacts on the broader health care system.”
A group of former FDA officials also supported the government and Danco, arguing that the earlier rulings “set the country on a dangerous path back to the piecemeal regulatory scheme that Congress rejected in 1938, when Congress decided that the best way to protect the public health and promote access to safe and effective medication was to rely on an expert agency to regulate and approve drugs.”
“Courts lack the expertise to step into FDA’s shoes by second-guessing FDA’s experts on the safety and efficacy of drugs,” they said.
“Assuming that role would require inexpert judges to learn how to do what FDA’s expert pharmacologists, toxicologists, chemists, epidemiologists, physicians, and data scientists have spent lifetimes training to do. Getting it wrong can lead to catastrophic consequences—measured not in dollars, but in human lives— and deprive patients of life-saving medication they depend upon.”
Mississippi and some other states, on the other hand, noted that the FDA has acknowledged there are adverse events associated with mifepristone, including severe bleeding requiring surgery, when the agency required that the drug be provided “by or under the supervision of a physician.”
The more recent allowance of dispensation by mail “disregards the protections for life, health, and safety adopted by numerous States’ elected representatives,” and is an overreach of the agency’s authority, the states said.
The pro-life Charlotte Lozier Institute also urged the court to keep the other rulings intact, arguing that allowing women to get the drug without visiting a doctor in person is dangerous.
Senate Majority Leader Chuck Schumer (D-N.Y.) and 252 other members of Congress urged the court to block the lower court rulings while Sen. Ted Cruz (R-Texas) and 146 other members said the court shouldn’t block the earlier rulings.
