The court's decision, which was unanimous, stated that the anti-abortion activists lacked the standing to sue and that conservative judges in Texas were unjustified in their attempts to overturn the Food and Drug Administration's (FDA) regulations permitting the delivery of these pills by mail.
However, the court's dismissal of the case on the grounds of standing does not preclude other anti-abortion advocates from launching a similar lawsuit against the FDA. Justice Brett M. Kavanaugh, writing for the unanimous court, stated, “The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
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In 2000, the FDA approved the use of mifepristone for terminating early pregnancies, deeming it safe and effective. The medication is typically used in conjunction with a second drug, misoprostol. Over the years, the FDA has eased its regulations for dispensing these pills, based on studies indicating that serious complications are "exceedingly rare." Under the revised rules, pregnant women can obtain a prescription via telemedicine and receive the pills from a pharmacy or through the mail. The medication can be used up to 10 weeks into a pregnancy, an increase from the previous limit of seven weeks.
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The Guttmacher Institute reported that abortion medication was used in 63% of U.S. abortions last year. The recent Supreme Court decision does not alter the law in states where abortions are illegal.
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Following the Supreme Court's repeal of the right to abortion in the Dobbs case, the Alliance Defending Freedom, a conservative Christian group, filed a lawsuit in Amarillo, Texas, seeking to overturn the FDA's approval of mifepristone. The plaintiffs, a group of doctors and healthcare activists from across the nation who oppose abortion, argue that the drugs are unsafe.
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Typically, plaintiffs must demonstrate personal harm from a federal law to have standing to sue. While these doctors do not perform abortions or dispense the drugs, they argued that some members of the group could potentially be on duty in an emergency room in the future, treating a patient suffering complications after taking the abortion pills.
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The lawsuit was filed in Amarillo with the expectation that it would come before U.S. District Judge Matthew Kacmaryk, a Trump appointee and Christian legal activist prior to his appointment. As anticipated, Kacsmaryk issued a broad ruling last year, granting the anti-abortion activists standing to sue and ordering the FDA to suspend its approval of the drugs.
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However, the U.S. Court of Appeals for the 5th Circuit later agreed to limit Kacsmaryk’s ruling. By a 2-1 vote, the appeals court stated it was too late to undo the drug's approval in 2000, but not too late to overturn the FDA’s regulations that have made it easier for women to obtain the pills since 2016.
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Solicitor Gen. Elizabeth B. Prelogar of the Biden administration appealed to the Supreme Court, calling the case a first. She stated that it “marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.”
