The U.S. Department of Justice responded Thursday to a ruling that limits access to the abortion pill mifepristone and said it would ask the Supreme Court for an emergency order to put any restrictions on hold.
After conflicting rulings by various courts on mifepristone, a pill that induces abortion and is the most commonly used method in the United States, a federal appeals court ruled Wednesday that it could be used for now but with some restrictions. They include reducing the period of time when the drug can be taken and prohibiting it from being mailed.
Mifepristone has been approved by the Food and Drug Administration for 23 years. Last week, Matthew Kacsmaryk, a U.S. district judge in Texas, reversed approval of the pill’s use following a lawsuit by opponents of abortion.
Less than an hour later, a judge in Washington state ordered the FDA to preserve access to the drug in 17 states and the District of Columbia.
In response, the New Orleans-based U.S. Court of Appeals for the Fifth Circuit voted late Wednesday to temporarily narrow the ruling by Kacsmaryk.
In a 2-1 vote, the judges on the appeals court put on hold changes made by the FDA in 2016 and 2021 that relaxed the rules for prescribing and dispensing mifepristone. The relaxed rules included allowing the pill to be sent through the mail, lifting a requirement for three in-person doctor visits, and approving the drug’s use for up to 10 weeks into a pregnancy, rather than seven weeks.
Preventing the pill from being sent by mail reduces abortion access. The reversal of Roe vs. Wade less than a year ago has resulted in more than a dozen states banning abortion outright. Roe vs. Wade was the case that recognized a constitutional right to abortion.
Reactions to rulings
Attorney General Merrick Garland said in a statement, “We 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.” Without the granting of an emergency order, the Court of Appeals’ ruling will go into effect on Saturday.
Vice President Kamala Harris issued a statement as well.
“There is a reproductive health care crisis in America. Our administration will continue fighting to protect women's health and the right to make decisions about one's own body,” she wrote.
Erin Hawley, a lead lawyer for the plaintiffs in the case, expressed satisfaction with the latest ruling.
“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” said Hawley, senior counsel for the conservative legal advocacy group Alliance Defending Freedom.
Abortion rights supporters or opponents could take the case to the Supreme Court. Opponents of the drug could try to keep the full Court of Appeals ruling in effect. Or, the Biden administration could ask the Supreme Court to allow all the FDA changes to remain in place while the case makes its way through the legal system.
Ruling alleges inadequate review
At the core of the Texas ruling is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.
Common side effects include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires a surgical intervention.
More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications, which represented less than one-tenth of 1% of women who took the drug.
In loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”
More than 250 pharmaceutical executives criticized the Texas judge’s decision in a public letter. They said it ignored decades of scientific evidence and legal precedent.
In the letter, they wrote, “We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place.”
Some information for this report came from The Associated Press, Agence France Presse and Reuters.
