Supreme Court unanimously maintains access to abortion pill

The Supreme Court delivered a unanimous verdict on Thursday, ruling that an anti-abortion group's challenge against the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone lacks legal standing. This decision concludes a high-profile legal dispute, affirming the FDA's authority and maintaining the current accessibility of mifepristone.

The Justices determined that the plaintiffs, who aimed to restrict the availability of mifepristone, failed to demonstrate any direct harm from the FDA's regulatory decisions. Justice Brett Kavanaugh, writing for the court, noted that the plaintiffs did not suffer any injury in fact from the FDA’s actions, making the federal courts an inappropriate venue for their grievances. The ruling thus overturns a lower court decision that could have restricted mifepristone's availability and keeps the current regulations, including mail-order prescriptions and usage up to 10 weeks of pregnancy, intact.

While this ruling preserves access to mifepristone, abortion remains outlawed in states with legislation following the overturning of Roe v. Wade. The Supreme Court’s focus on the standing issue meant it did not address broader debates on the FDA’s regulation of the drug.

Since its approval by the FDA in 2000, mifepristone has been used together with misoprostol for medication abortions. Research over the past two decades has consistently shown mifepristone to be both safe and effective. Medication abortions have accounted for a growing share of all abortions in the U.S., surpassing 60% after Roe v. Wade was reversed.

The legal challenge originated in 2022, when the Alliance for Hippocratic Medicine sued the FDA, questioning its approval of mifepristone. This case emerged shortly after the Supreme Court dismantled Roe v. Wade, a decision that had previously established the constitutional right to an abortion. Initial rulings from a Texas district court and subsequent appeals jeopardized the drug’s availability and raised concerns about potential judicial overreach into the FDA’s scientific decision-making process.

Biotechnology industry leaders voiced alarm over the implications of the case, fearing it could set a precedent for judicial interventions in drug approvals. However, the Supreme Court’s decision quashed these fears by rejecting the plaintiffs’ claims of harm.

During oral arguments in March, the Supreme Court justices expressed skepticism towards the plaintiffs' arguments. The Alliance had contended that the FDA’s decisions to broaden mifepristone’s approval between 2016 and 2021 led to increased emergency room visits and posed potential harm to doctors opposing abortion who might need to address complications from its use. However, the Justices highlighted existing legal protections for medical professionals, which safeguard doctors from being compelled to perform abortions or treatments contrary to their beliefs. Justice Kavanaugh emphasized that these protections negate any claimed injuries related to conscience.

The legal contest began with the Alliance's lawsuit against the FDA, asserting wrongful approval of mifepristone. Conservative Judge Matthew Kacsmaryk of the U.S. District Court initially ruled to invalidate the FDA’s approval, prompting a series of appeals and counter-rulings. In response, a judge in Washington ordered the FDA to maintain mifepristone’s status in 17 states led by Democrats seeking broader access.

Upon appeals from Danco Laboratories and the Biden administration, the U.S. Court of Appeals for the 5th Circuit partially blocked Judge Kacsmaryk’s decision, stating the Alliance’s challenge was too delayed to overturn the 2000 approval. However, the court did restrict some recent FDA labeling expansions. This led to further appeals, propelling the case to the Supreme Court, which had placed a temporary hold on the lower court's decision during its deliberations.

The Supreme Court's verdict on Thursday overturns the 5th Circuit’s ruling, ensuring mifepristone remains accessible under the current FDA guidelines. Justice Clarence Thomas provided a concurring opinion alongside Kavanaugh’s.