Republican-led states are restarting efforts to limit access to mifepristone, the primary drug used in medication abortions, in a bid to address what some experts saw as deficiencies in the case recently decided at the Supreme Court this past spring.

Kansas, Idaho, and Missouri are leading a renewed legal challenge against the efforts of the Food and Drug Administration to deregulate the abortion pill mifepristone and the agency’s 2016 decision to relax regulations that had been in place since 2000.

In March, the Supreme Court dismissed a case filed by anti-abortion physicians against the relaxed restrictions, saying that the doctors lacked standing to bring the suit.

But the burden for a state-based lawsuit against the federal government is generally significantly lower. In this case, the three plaintiff states argue they are bringing a viable case because the wide access to mifepristone violates their authority as states to regulate or prohibit harmful substances or procedures.

“We are moving forward undeterred for the safety of women across the country,” Missouri Attorney General Andrew Bailey told the Washington Examiner.

The latest court filing seeks to roll back federal rules that have made it easier to obtain mifepristone, including the removal of in-person screening requirements before a physician could dispense the medication. 

The three states argue the FDA’s relaxation of these requirements undermines their own abortion laws and frustrates state enforcement efforts. 

Their lawsuit was filed in a federal court in Texas, the same court that previously heard the case, before the Supreme Court ruled in June that the plaintiffs lacked standing to challenge the FDA’s approval of mifepristone. 

Addressing ‘Deficiencies’ in Supreme Court’s Ruling

The Supreme Court unanimously decided last term to maintain the FDA’s deregulation of the abortion pill on the basis that doctors with the Alliance for Hippocratic Medicine did not suffer an “injury in fact” because they did not prescribe mifepristone.

But the three states contend that not only are women in their states harmed by widespread abortion pill complications but also the ability to mail abortion pills across state lines violates their ability to regulate abortion within their jurisdiction.

Under the FDA’s regulation, which allows anyone with a health professional license to prescribe mifepristone, patients in states with abortion bans are able to obtain the medication from prescribers in other states. 

Five states, including Colorado, Massachusetts, New York, Washington, and Vermont, have passed so-called “shield laws” that protect mifepristone prescribers from prosecution and medical liability in states with abortion bans. 

The plaintiff states argue that the FDA’s deregulation of mifepristone does present an avenue for legal standing because it undermines state-level abortion bans, saying that the plaintiff states “have suffered injury to their sovereign interests in enacting and enforcing their laws.”

From July 2023 to March 2024, over 65,000 women in states with total or six-week abortion restriction accessed abortion pills from prescribers in states with shield laws, according to the Society of Family Planning. 

Ilya Shapiro, a senior fellow at the Manhattan Institute, said the new lawsuit may address some of the key issues that the Supreme Court identified in its earlier decision.

“The amended complaint shores up a lot of the deficiencies the Supreme Court identified, but the Court’s standing-based opinion was really more of a cop-out than anything else, so it will depend on whether enough justices have the political will to take this up,” Shapiro told the Washington Examiner.

Shapiro also referenced the case of Amber Nicole Thurman, a mother in Georgia who died in August 2022 as a result of not receiving treatment for sepsis following abortion pill complications, a risk of abortion pills that is often not widely discussed, according to anti-abortion advocates. 

Thurman’s story has been touted by Democrats, including Vice President Kamala Harris, in the 2024 election cycle. They say that her death is an example of how limits or prohibitions on abortion are harmful to women’s health. 

Shapiro said, however, that he hopes Thurman’s death from mifepristone complications will spur higher-level courts to take renewed interest in the states’s concerns that abortion pills themselves are harmful.

The amended complaint focuses on restoring safeguards that the states believe are critical to protecting women’s health. This includes restoring the original gestational age limit to 10 weeks, up from the current seven, as well as requiring ultrasound examinations to rule out pregnancy complications that would render mifepristone ineffective, like ectopic pregnancy.

Julie Marie Blake, senior counsel for Alliance Defending Freedom, expressed support for the states’ ongoing efforts to challenge the FDA’s policies in a statement to the Washington Examiner.

“We support the states’ continued efforts to hold the FDA accountable for its reckless endangerment of women,” said Blake, whose group ADF represented the case at the high court when the plaintiffs were previously only a group of doctors who had conscientious objections to using the abortion pill.

Legal and Medical Debate Continues

The lawsuit has revived a larger debate over the safety of medication abortions and the balance between federal and state regulation. 

Chemical abortions, also known as self-managed abortions, involve the drug combination mifepristone and misoprostol. Mifepristone cuts off the hormone supply necessary to sustain fetal development, while misoprostol induces contractions to expel the pregnancy tissue.

The FDA’s warning label for mifepristone estimates that approximately 4%, or about one in 25, who take mifepristone will encounter significant bleeding or infection requiring emergency medical treatment. This statistic comes from insurance coding following patients who seek emergency medical attention and is widely cited by anti-abortion advocates

In 2023, about 643,000 abortions in the United States used mifepristone. Considering a 4% complication rate, that equates to roughly 26,000 women experiencing potentially life-threatening complications from mifepristone.

Studies cited by abortion rights advocates have shown that serious complications from mifepristone are rare, with OB-GYNs estimating that major adverse events occur in approximately one in every 300 patients. This statistic is based on the number of adverse incidents reported to the FDA, but the agency no longer requires doctors to report adverse outcomes.

Abortion rights advocates and certain medical experts counter that the restrictions are not necessary. Dr. Rebecca Gomperts, founder of Aid Access, argues that mifepristone is safe and that the new legal challenges are politically motivated.

“The document submitted is full of lies,” Gomperts said of the GOP states’ renewed challenge. “There is overwhelming scientific proof that telemedical abortions done at home for pregnancies up to 13 weeks are as safe as in-clinic abortions.”

State Attorneys General Lead the Charge

Missouri’s attorney general, one of the leading figures in the renewed challenge, emphasized the health risks he believes are associated with the drug’s expanded availability.

“The Biden-Harris Administration has removed their long-standing safety requirement for doctors to provide care to women adversely affected by mifepristone. Women deserve adequate medical care rather than hemorrhaging alone at home because Joe Biden and Kamala Harris think they know better than medical professionals do,” Bailey told the Washington Examiner. 

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Similarly, Kansas Attorney General Kris Kobach highlighted what he sees as alarming risks tied to mifepristone.

“Even the FDA’s own label says that roughly 1 in 25 women who take this drug will end up in the emergency room,” Kobach told the Washington Examiner. “Data cited by the FDA also showed that hospitalizations from using mifepristone increased by 300% when taken without in-person doctor’s visits. We’re pursuing this case to protect Kansas women.”