The Supreme Court recently made a significant ruling regarding the FDA's regulatory approval process for the abortion drug mifepristone. This decision comes in the wake of the landmark ruling in 2022 that overturned Roe v. Wade, a pivotal case in abortion rights.
In a unanimous decision, the high court determined that the challengers to the FDA lacked standing to sue the government. Justice Brett Kavanaugh, who authored the opinion, emphasized that a plaintiff's objections to a drug's availability do not automatically grant them the right to sue under Article III of the Constitution.
The court highlighted that the plaintiffs' concerns about elective abortion and the FDA's regulation of mifepristone, while sincere, do not establish a justiciable case or controversy in federal court. The ruling emphasized that the federal courts are not the appropriate forum for addressing such concerns.
The decision underscores the importance of engaging in the regulatory and legislative processes to address objections to FDA actions. The court suggested that the plaintiffs could voice their concerns to the President, FDA, Congress, and fellow citizens through political and electoral processes.
Earlier this year, the Supreme Court heard arguments about federal regulations that eased access to mifepristone since 2016, including mail access. The ruling in Dobbs v. Jackson Women’s Health Organization in June 2022, which overturned Roe v. Wade, shifted the abortion landscape to state-level decisions.
Following the Dobbs ruling, several states have enacted strict abortion bans, with some prohibiting abortion at all stages of pregnancy and others banning it once a fetal heartbeat is detected at around six weeks of gestation.
The Biden administration and the manufacturer of mifepristone sought to reverse an appellate ruling that would have restricted access to the drug, including by mail, and imposed additional limitations even in states where abortion is legal. The proposed restrictions included shortening the window for using mifepristone from 10 weeks to seven weeks in pregnancy.
