The Supreme Court seems likely to support the FDA in a case involving the accessibility of the abortion pill mifepristone, which was approved in 2000 and has been used by over 5 million patients. The FDA made changes in 2016 and 2021 to make the medication more accessible, including allowing it to be taken later in pregnancy and delivered through mail without requiring an in-person doctor’s visit. A group of doctors and medical associations challenged these changes, claiming the FDA violated the law.
The legal battle centers around whether the doctors challenging the FDA’s actions have the legal standing to sue, as well as whether the FDA’s actions were within the bounds of the law. If the Supreme Court decides the doctors lack standing, the case could be dismissed without a decision on the FDA’s actions. The dispute raises questions about the impact of legal challenges on drug approval processes and patient access to critical medications.
Pharmaceutical companies and former FDA heads have warned the Court that upholding the lower court’s decision could jeopardize the agency’s drug approval process. On the other hand, opponents of the FDA’s changes argue that the agency failed to provide a satisfactory explanation for lifting certain requirements, risking the safety and well-being of women. The Supreme Court’s decision is awaited by the end of June, and it will have significant implications for women’s access to mifepristone and the FDA’s regulatory authority.
