Abortion drug battle will head to Supreme Court after appeals court decision

The Justice Department said Thursday that it will take the battle over abortion pill access to the U.S. Supreme Court after an appeals court allowed it to stay on the market with restrictions.

Under a ruling from the 5th U.S. Circuit Court of Appeals in New Orleans late Wednesday, the drug, mifepristone, will remain available, but the judges said it could no longer be sent to patients through the mail and that it could only be used up to seven weeks into a pregnancy, not 10.

The Justice Department “strongly disagrees” with that decision and “will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Attorney General Merrick Garland said in a statement.

The appeals court panel said its order would remain in place until the court hears the case.

Last week, a federal judge in Texas ruled that the Food and Drug Administration had improperly approved the drug in 2000, threatening access to the medication around the country. The judge, Matthew Kacsmaryk, paused his ruling for one week to allow for appeals.

The suit was brought by anti-abortion advocates who argued that regulators erred in approving mifepristone by not fully considering possible safety risks. It could ultimately wind up before the U.S. Supreme Court.

Both the FDA and the Justice Department appealed Kacsmaryk’s ruling, as did Danco Laboratories, which makes a branded version of mifepristone.

Medical experts have noted that millions of people have used mifepristone in the more than two decades since it became available, and that it’s widely considered to be a very safe medication, with very low rates of side effects.

In its order, the three-judge appellate panel said that too much time had elapsed for the plaintiffs to challenge the original approval of mifepristone. But the judges wrote that the plaintiffs could argue against more recent steps the FDA took starting in 2016 that have eased access to the medication, including extending its use to 10 weeks from the original seven and allowing it to be delivered through the mail. Those measures have been placed on hold.

Since Kacsmaryk’s decision, some states led by Democratic governors have been stockpiling mifepristone. Meanwhile, drug company executives have been warning that the Texas judge’s ruling could undermine the nation’s entire infrastructure for approving and regulating drugs and vaccines.

Mifepristone is taken with a second drug, misoprostol, a combination that is thought to account for more than half of abortions nationwide. If mifepristone is taken off the market, patients could take just misoprostol, but that method is seen as less effective and comes with higher rates of nausea and cramps.

Shortly after the Texas decision was handed down last Friday, a federal judge in Washington state released a decision that orders the FDA to ensure the continued availability of mifepristone. That judge, Thomas Rice, issued a preliminary injunction that would prevent the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”

Update: This story was updated to include the Justice Department’s decision to seek emergency relief from the Supreme Court.