Texas and Florida have filed the most recent federal lawsuit challenging the U.S. Food and Drug Administration’s approval of the abortion pill mifepristone, reigniting a contentious legal battle over medication abortion in the United States. The action, brought in the Northern District of Texas, targets both the original 2000 approval of the drug and the agency’s more recent authorisation of a generic version, reflecting a sustained effort by Republican-led states to contest the regulatory process and oversight of reproductive health products.
In their complaint, attorneys general from both states argue the FDA failed to adequately assess the safety and effectiveness of mifepristone, claiming the agency’s decisions were arbitrary, politically driven and in violation of the Administrative Procedure Act. The states also challenged expanded access measures adopted under previous administrations, such as remote prescriptions and mail delivery, while contending that these regulatory changes have exceeded the agency’s statutory authority.
Mifepristone, which is used with misoprostol for medication abortions within the first ten weeks of pregnancy, is central to more than 60 per cent of U.S. abortions, making it a focal point in broader national debates over reproductive rights and regulatory reach. The new lawsuit mirrors claims raised in earlier litigation brought by Missouri, Kansas and Idaho, although in 2024 the U.S. Supreme Court ruled that those plaintiffs lacked the necessary legal standing to challenge FDA regulations, avoiding a direct national ruling on the merits of the approval process itself.
Unlike the prior case, which was transferred out of Texas due to questions about direct ties, the latest filing may proceed through the conservative-leaning Fifth Circuit Court of Appeals if it survives initial procedural challenges. The FDA has not formally responded as of the filing, leaving open how the agency will defend its longstanding regulatory framework for mifepristone and whether broader restrictions could ultimately affect access.
The renewed litigation highlights unresolved tensions between state efforts to restrict abortion-related products and federal authority over drug approvals, and it raises questions about how courts will balance procedural challenges with established regulatory precedents in future decisions.
