High Court Issues Temporary Stay on Mifepristone Restrictions
On April 10, 2023, the U.S. Supreme Court intervened in a major reproductive rights case by issuing a temporary stay that prevents new restrictions on the abortion medication mifepristone from taking effect. This emergency action effectively maintains the status quo for access to the drug while a legal battle continues to unfold in the lower courts, underscoring the pivotal role the judiciary now plays in shaping the future of abortion access in the United States.
The dispute stems from an earlier decision by the Fifth Circuit Court of Appeals, which allowed the Food and Drug Administration’s (FDA) original 2000 approval of mifepristone to remain in place but imposed significant new limitations. These included prohibiting mail delivery of the drug, reducing the permissible gestational age for its use from 10 weeks to 7 weeks, and requiring in-person physician visits for dispensing the medication.
Legal Background: FDA v. Alliance for Hippocratic Medicine
The case, known as FDA v. Alliance for Hippocratic Medicine, originated in Texas where a coalition of anti-abortion medical organizations sued the FDA, challenging its approval process and subsequent regulatory decisions that expanded access to mifepristone. The plaintiffs argued that the FDA’s actions were unlawful and unsafe, while the government and reproductive rights advocates maintained that the medication had a strong safety record and was backed by more than two decades of clinical use and data.
In response to the Fifth Circuit’s ruling, the Department of Justice and Danco Laboratories (the manufacturer of mifepristone) filed emergency appeals with the Supreme Court. The high court’s stay temporarily halts the lower court’s restrictions, ensuring that mifepristone remains accessible by mail and up to 10 weeks into pregnancy—at least while the case proceeds.
National Impact on Reproductive Healthcare
The Supreme Court’s decision has national implications. Mifepristone is part of a two-drug regimen, alongside misoprostol, used in more than half of all abortions in the United States. The drug’s accessibility—particularly through telehealth and mail-order pharmacies—has become increasingly vital in the wake of Dobbs v. Jackson Women’s Health Organization, the 2022 ruling that overturned Roe v. Wade and returned abortion policy to individual states.
In the months following the Dobbs decision, abortion bans and restrictions proliferated in several states, making medication abortion one of the few remaining options for individuals in restrictive jurisdictions. The legal attack on mifepristone is seen by many reproductive rights advocates as the next phase in a broader strategy to limit abortion nationwide, even in states where it remains legal.
The FDA and numerous health organizations, including the American College of Obstetricians and Gynecologists, have maintained that mifepristone is safe and effective, with a safety profile comparable to or better than many commonly used drugs, including penicillin and Viagra.
Judicial Oversight of FDA Authority
Beyond the immediate reproductive health implications, the case also raises critical questions about the scope of judicial review over federal regulatory agencies. Legal scholars warn that if courts begin overriding FDA decisions based on ideological or political grounds, it could undermine scientific integrity and destabilize regulatory oversight across the healthcare system.
The Biden administration has echoed this concern, arguing that allowing courts to second-guess drug approvals would create a dangerous precedent that could discourage innovation and weaken public trust in medical regulation.
Next Steps
With the Supreme Court’s temporary stay in place, mifepristone remains available under current FDA guidelines while the case continues through the appeals process. The Court has instructed the parties to submit additional briefs as it weighs whether to allow the Fifth Circuit’s restrictions to take effect or to take up the case for full review.
The outcome could have lasting consequences—not only for reproductive rights but also for how public health policy is governed in the United States. As legal proceedings move forward, the nation remains sharply divided, with reproductive freedom advocates rallying to defend access and anti-abortion groups seeking further judicial intervention.
Source:
Wikipedia – FDA v. Alliance for Hippocratic Medicine
