Washington, D.C. – The Supreme Court tackled a case involving mifepristone, a widely used abortion pill, and the recent efforts by the Food and Drug Administration to ease access to the medication. The legal battle centered around mifepristone, which, when used in conjunction with another drug, terminates early pregnancies. Since its approval by the FDA in 2000, over 5 million patients have utilized mifepristone, with studies cited in court filings demonstrating its safety and effectiveness.
In recent years, the FDA has implemented measures to increase accessibility to mifepristone, such as allowing it to be taken up to 10 weeks into pregnancy and permitting delivery by mail without an in-person doctor’s visit. These changes, made in 2016 and 2021, faced legal challenges from a group of anti-abortion rights doctors and medical associations, alleging that the FDA violated the law by relaxing regulations.
A federal appeals court decision, which the Supreme Court is reviewing, deemed the FDA’s actions unlawful. If upheld, this ruling could restrict mifepristone access nationwide, affecting states with laws safeguarding abortion rights. Solicitor General Elizabeth Prelogar argued that undoing the FDA’s changes would significantly harm women across the country.
While legal proceedings continue, access to mifepristone remains unaffected, following a Supreme Court order in April maintaining its availability until a final decision is reached by the end of June. This case arrives amid a broader legal landscape following the Supreme Court’s 2022 decision to devolve abortion rights back to the states, indicating a shift in the court’s approach to reproductive rights.
The Supreme Court’s deliberations on mifepristone coincide with rising rates of medication abortions in the U.S. post the overturning of Roe v. Wade. Recent studies underscore a growing trend in self-managed abortions through pills since this pivotal legal decision, with the Guttmacher Institute reporting an increase in medication abortions within the U.S. healthcare system.
The FDA’s actions on mifepristone have been met with challenges from medical associations opposing abortion rights, culminating in a legal battle questioning the agency’s authority in approving and regulating the drug. The arguments put forth by both the Biden administration and the medical groups hinge on issues of legal standing, safety, and the FDA’s regulatory decision-making process.
As the Supreme Court deliberates, the potential implications of its ruling extend beyond mifepristone, with implications for the broader drug-approval process and legal challenges to FDA decisions. A decision in favor of the doctors could set a precedent for judicial review of FDA regulations, while a ruling upholding the FDA’s actions may signal deference to the agency’s expertise and judgment in drug approval processes.