


The legal battle over the Food and Drug Administration’s approval of the abortion pill is not dead, even after the Supreme Court bucked the issue in June and refused to decide whether federal regulations authorizing mifepristone should be scaled back.
In the coming weeks, Kansas, Idaho and Missouri will resume their challenge of the FDA’s approval of the abortion drug. The challenge has been on hold in anticipation of the Supreme Court ruling.
“We are confident, as the case begins moving again, we will prevail,” said Kansas Attorney General Kris Kobach. “It is likely that this case may end up back at the Supreme Court. It is a question of major national importance.”
Last year, the states filed a complaint in the Northern District Court in Texas challenging the pill’s use further into pregnancy, its generic form and its dispense through the mail.
The states claim economic harm from the increase in chemical abortions because Medicaid recipients experiencing complications must visit emergency rooms.
They say more women develop health issues that require emergency treatment or hospital stays after taking the pill than women who have surgical abortions.
“These higher complication rates, ER rates, and hospitalization rates for chemical abortions cause direct economic harms on Plaintiff States in several ways,” said their complaint, noting costs related to public insurance and hospitals.
The federal government has not yet responded to the states’ complaint.
The states’ litigation was put on hold for months while the Supreme Court weighed an issue brought by pro-life doctors contesting the FDA’s decisions.
The pro-life doctors argued that mifepristone should never have been approved more than two decades ago during the Clinton administration. They also challenged recent FDA changes allowing the pill to be mailed to patients without in-person doctor visits and to be used up to 10 weeks into pregnancy instead of the original seven weeks.
The pro-life doctors won at the lower court level, but the Supreme Court said they did not have legal standing or sufficient injury to sue. In a unanimous ruling, the justices said the doctors’ moral objections to mifepristone may be valid but aren’t enough to show legal injury.
“For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions,” Justice Brett M. Kavanaugh wrote for the court.
The Food and Drug Administration approved mifepristone in 2000, and the restrictions have been steadily easing. The drug is used for nearly two-thirds of abortions in America.
Mifepristone was initially approved for use up to seven weeks into gestation but is now used as late as 10 weeks. Requirements that the drug be picked up in person have been eliminated, and the number of in-person doctor’s visits that were originally required has been cut.
The Biden administration said in court that the rules were relaxed after careful study to ensure they would not harm women’s health.
The American Medical Association said mifepristone also is used in cases of miscarriage, and the restrictions made care for those women more difficult.
A federal judge, in considering the pro-life doctors’ challenge, found flaws in the FDA’s process and ruled that the initial approval was illegal.
The 5th U.S. Circuit Court of Appeals narrowed that ruling. It said too much time had passed to challenge the initial approval, but more recent changes, such as distribution by mail and use later in pregnancy, could be challenged.
The Supreme Court’s decision voided those lower court findings.
The pill remained available under a Supreme Court order while the case awaited the justices’ ruling.
Just last week, the Society of Family Planning, which supports access to abortion, reported a slight increase in the procedure during the first three months of this year than before the high court overturned Roe v. Wade in 2022.
The court’s ruling in Dobbs v. Jackson Women’s Health Organization returned jurisdiction over abortions to the states, prompting bans on the procedure and challenges to pro-choice policies.
Pro-life advocates see the states’ pending complaint as the new avenue to curtail the use of the abortion pill that they say is putting women’s lives at risk.
“Two federal courts found the FDA likely violated the law and the Supreme Court did not rule on the merits of this case, but rather said the doctors who brought the litigation lacked standing. Those who care about women’s health and safety will continue to fight to stop the Biden-Harris FDA from putting their ideological commitment to abortion ahead of women’s safety,” said Katie Glenn Daniel, state policy director for Susan B. Anthony Pro-Life America.
Penny Nance, president of Concerned Women for America, said the Supreme Court never actually weighed in on the federal removal of safety regulations that were intended to protect women.
“It merely ruled the doctors challenging the FDA’s actions lacked standing. Well, the intervening states here clearly have standing to challenge the agency’s actions, and we are hopeful that the justices will finally take a look at the troubling facts underlying this case,” Ms. Nance said.
“The FDA label itself says that around one in 25 women who take chemical abortion drugs will end up in the emergency room. States have more than a legitimate interest to protect mothers and preborn children. Concerned Women for America members are praying that justice will be done in this case, and the FDA will be held accountable for its reckless disregard of women’s safety in its hasty and unnecessary approval of this dangerous drug regimen,” she added.
The Justice Department did not immediately respond to a request for comment about the states’ action.
After the Supreme Court issued its June 13 decision eliminating the pro-life doctors’ challenge, Attorney General Merrick Garland praised the justices’ decision.
He vowed to continue fighting to keep the drug available.
“The Department will continue to work tirelessly to protect and advance reproductive freedoms under federal law,” Mr. Garland said. “The Department of Justice is committed to protecting reproductive freedom. We will continue to use every tool at our disposal to protect women’s access to mifepristone and other lawful reproductive care.”
• Stephen Dinan contributed to this report.
• Alex Swoyer can be reached at aswoyer@washingtontimes.com.