Written by Ashton Snyder on
 June 14, 2024

Supreme Court Upholds FDA Approval of Mifepristone, Denies Standing to Challengers

The U.S. Supreme Court has settled a significant case involving the abortion medication mifepristone in a ruling that preserves access to the drug.

The Supreme Court ruled that challengers to the FDA's regulatory approval process of the abortion drug mifepristone lacked standing to sue, thereby maintaining access to the drug.

As reported by Fox News, the Supreme Court delivered a unanimous decision on Thursday, rejecting the argument that the FDA's approval process for mifepristone should be challenged. This decision is a continuation of the high court's indirect involvement with abortion rights following the reversal of Roe v. Wade in 2022.

Justice Kavanaugh’s Unanimous Opinion

Justice Brett Kavanaugh, authoring the unanimous opinion, clarified the Court's rationale. He emphasized that the challengers failed to show a direct injury due to the FDA's relaxed regulations. According to Kavanaugh, "a plaintiff's desire to make a drug less available for others does not establish standing to sue."

This case has been remanded to the Fifth Circuit Court. The original challenge originated from several healthcare associations, including the Alliance for Hippocratic Medicine, arguing that mifepristone had a high rate of complications.

Impact on FDA Regulations

The ruling has broader implications for the FDA's drug approval process. The Supreme Court's decision prevents the introduction of new restrictions on mifepristone. This maintains the regulatory adjustments the FDA has made since 2016, which include reducing the recommended dosage, extending its use up to ten weeks of pregnancy, approving a generic version, and authorizing mailing the drug.

The Biden administration and Danco, the drug's manufacturer, had pushed to reverse an appellate ruling that aimed to restrict access to mifepristone. Nearly two-thirds of abortions in the U.S. in 2023 involved mifepristone, underscoring its significance since its approval 24 years ago, affecting roughly six million women.

Reactions from Opponents and Supporters

Erin Hawley, counsel for the Alliance Defending Freedom, expressed her disappointment, stating, "We are disappointed that the Supreme Court did not reach the merits of the FDA's lawless removal of common sense safety standards." She criticized the FDA for leaving women to take these drugs without the ongoing care of a doctor.

On the other hand, Abigail Long, spokesperson for Danco, praised the ruling, noting, "We are pleased with the Supreme Court’s decision in this incredibly important case." Long highlighted that the decision reaffirms the basic principles of administrative law, ensuring stability in the FDA drug approval process.

Broader Implications for Reproductive Rights

Attorney General Merrick Garland welcomed the decision. He reiterated the right of women in states restricting comprehensive reproductive care to travel to states where such care is legal. Garland also defended the ability to inform and counsel regarding reproductive care across state lines and stressed the safety and efficacy of mifepristone.

Justice Clarence Thomas, though, raised concerns about "associational standing," pointing out that the Alliance's effort to apply this doctrine showed a deviation from traditional rules, advocating that plaintiffs must assert only their injuries.

Critics of the FDA, including Hawley, argue that safety standards have been compromised. They cite the need for initial office visits to screen for conditions like ectopic pregnancies. Hawley mentioned that states would hold the FDA accountable for any health risks posed to women by these drugs.

Final Thoughts and Ongoing Debate

The Supreme Court's decision underscores a significant victory for the Biden administration and supporters of abortion rights. However, it also highlights ongoing debates about the regulatory framework for abortion drugs and the balance between ensuring safety and maintaining access. The case's return to the Fifth Circuit may continue to influence future regulatory and legal landscapes surrounding reproductive rights, marking a critical moment in an already contentious issue in American public policy.

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About Ashton Snyder

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