Supreme Court takes up abortion pill dispute 

The Supreme Court said Wednesday it will take up a case that could limit the availability of the common abortion pill mifepristone, bringing the issue of abortion back to the court more than a year after the justices ended the constitutional right to one.

The court granted a request from the Justice Department and one from Danco, the manufacturer of Mifeprex, the branded version of mifepristone.

The brief orders consolidate the two cases and set them up to be heard this term, with a decision expected by the end of June. 

While the Supreme Court’s 6-3 conservative majority overturned Roe v. Wade and has appeared hostile to abortion, an emergency ruling by the Court in April has kept access to mifepristone unchanged.

Mifepristone is widely used across the U.S. to end a pregnancy in the first 10 weeks of gestation. It was first approved in 2000, and about half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen, according to the Guttmacher Institute, a reproductive rights research and advocacy group. It is also used to help manage miscarriages.

The lawsuit is not focused on abortion access, but rather the Food and Drug Administration’s (FDA) drug approval process. The decision could have major implications for the biopharma industry and FDA’s approval authority.

The U.S. Court of Appeals for the 5th Circuit ruled in August that mifepristone — both Mifeprex and its generic counterpart — can stay on the market in states where abortion is legal, but changes the FDA made since 2016 to ease access to the drug were not allowed because the agency did not follow proper procedure in enacting them.

The Biden administration and the manufacturer both appealed that latter portion to the Supreme Court, urging the justices to preserve the recent changes as lawful. Medical associations, drug companies and the FDA have all said mifepristone is safe and has much lower risks of complications than other common drugs like Tylenol or Viagra.

The group of anti-abortion providers that brought the suit, represented by Alliance Defending Freedom (ADF), a conservative Christian legal powerhouse, urged the high court to stay out the case.

But the ADF told the justices that if they did hear the appeals from the Justice Department and Danco, they should review the entirety of the earlier ruling — including whether mifepristone should remain on the market at all.

The Supreme Court’s orders reject that request, agreeing only to weigh in on the changes made after 2016 that eased access. Those changes included allowing the drugs to be sent by mail, and extending the window in which mifepristone can be used to terminate pregnancies from seven weeks’ gestation to 10 weeks.

“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions. We urge the Supreme Court to do the same,” Erin Hawley, senior counsel at ADF said in a statement. “The FDA has harmed the health of women and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen.”

The Biden administration warned that upending mifepristone’s original approval would disrupt the “long-established status quo” and call into question the FDA’s broader authority.

“The agency has maintained that scientific judgment across five presidential administrations, while updating the drug’s approved conditions of use based on additional evidence and experience,” the Department of Justice wrote in a court filing. “More than five million Americans have relied on mifepristone to terminate their pregnancies, and public health authorities around the world have likewise approved the drug.” 

In a statement, White House press secretary Karine Jean Pierre said in a statement the administration stands by FDA’s approval of mifepristone as safe and effective.

“As the Department of Justice continues defending the FDA’s actions before the Supreme Court, President Biden and Vice President Harris remain firmly committed to defending women’s ability to access reproductive care. We continue to urge Congress to pass a law restoring the protections of Roe v. Wade—the only way to ensure the right to choose for women in every state,” Jean Pierre said.

Updated at 12:30 p.m.