Supreme Court Temporarily Halts New Restrictions on Abortion Pill

American women's access to the abortion pill mifepristone was protected, temporarily, in a 7-2 ruling on April 21 by the U.S. Supreme Court.

The Supreme Court order, issued just before restrictions were set to go into effect, means mifepristone, one of two prescription medications used in medication abortions, remains accessible in abortion-legal states.

With Justices Clarence Thomas and Samuel Alito Jr. dissenting, the Supreme Court granted the Department of Justice's request to uphold the Food and Drug Administration's 23-year-old approval of the drug while the issue makes its way through the legal system.

"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," President Joe Biden said in an April 21 news release. "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."

The ongoing legal battle

Mifepristone is the subject of the latest legal reproductive rights challenge in which the future of medical abortion as it is currently practiced hangs in the balance.

A Texas federal court ruling overturned FDA approval of the drug, in effect making the drug illegal to dispense even in states where abortion is allowed.

U.S. District Court Judge Matthew J. Kacsmaryk, of the Northern District of Texas, appointed by former President Donald Trump, issued a preliminary decision April 7 revoking the FDA's two-decade-old approval of mifepristone, one of two prescription medications, along with misoprostol, used in medication abortions.

In the case, Alliance for Hippocratic Medicine v. FDA, Kacsmaryk sided with the plaintiffs' claim that the FDA didn't appropriately vet the drug before its approval in 2000.

Making the mifepristone matter more complicated, U.S. District Judge Thomas O. Rice, an appointee of former President Barack Obama in Washington state, filed a contradictory ruling in a separate case the same day. It's a multistate federal lawsuit filed in February in the Eastern District of Washington by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum. Rice's preliminary injunction declared the FDA should not make any changes that could restrict access to the abortion medication in states that legally allow abortion.

A 5th Circuit Court of Appeals ruling April 12, in response to an appeal by the Department of Justice, stayed the portion of the lower court's ruling that undid the FDA's approval of mifepristone but left the rest of the ruling intact. Modifications to the FDA's original approval made since 2016 were rolled back, meaning telehealth prescriptions cannot be made and getting a prescription requires three in-person doctor's visits, among other requirements.

Following the Supreme Court's decision, the case now goes back to the 5th Circuit federal appeals court.

How did we get here?

America's most common form of abortion is in legal peril less than a year after the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization essentially overturned Roe v. Wade, the precedent that long protected a woman's constitutional right to abortion care.

Erik Baptist, senior counsel at Alliance Defending Freedom, representing the plaintiffs in the Texas case, told NBC News that "the goal of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs."

"We are not seeking a nationwide abortion ban. We're focusing on one means of abortion here because it's dangerous," Baptist said in the March 14 news report.

In a 67-page ruling, Kacsmaryk sided, in part, with the Alliance for Hippocratic Medicine, a Texas nonprofit group with anti-abortion ties, invalidating the FDA's 23-year-old approval of mifepristone. The judge's ruling alleges the FDA "stonewalled judicial review until now," putting women at risk of side effects from mifepristone.

The Biden administration and medical organizations, including the American Medical Association (AMA), were quick to issue statements denouncing Kacsmaryk's decision.

"The court, in this case, has substituted its judgment for FDA, the expert agency that approves drugs," Biden said in an April 7 statement on the Texas ruling. "If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks."

U.S. Attorney General Merrick Garland said the Justice Department would continue to defend the FDA's decision regarding the abortion pill.

"The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court's decision and seeking a stay pending appeal," Garland said in a statement on April 7. 

"Today's decision overturns the FDA's expert judgment, rendered over two decades ago, that mifepristone is safe and effective…The department is committed to protecting Americans' access to legal reproductive care," Garland added.

The Department of Justice, representing the FDA, filed its appeal April 10.

Potential ramifications

"[The ruling in Texas] flies in the face of science and evidence and threatens to upend access to a safe and effective drug that has been used by millions of people for more than 20 years," said AMA President Jack Resneck Jr., M.D., in an April 7 statement.

"The court's disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation. By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians," Resneck added.

Resneck said mifepristone has been "studied extensively" and proved safe for more than two decades. By prohibiting mifepristone, he said patients would be forced to consider "a less effective treatment" using a higher dose of misoprostol on its own.

"There is no evidence that people are harmed by having access to this safe and effective medication," Resneck said in his AMA statement. "To the contrary, there is substantial evidence that the denial of needed abortion care without justification carries a psychological, physical and economic toll. For people who do not have access to procedural abortion or adequate medical facilities, there may be no other options to obtain critically needed care.”

The AMA has vowed to not let this ruling affect how it approaches care.

"We will continue to support access to evidence-based healthcare, including abortion medication, and oppose intrusions that undermine our patients' health," Resneck said.