USP statement on mifepristone approval oral argument before the Supreme Court

Rockville, MD, March 28, 2024 -The U.S. Supreme Court heard arguments this week related to the approval of mifepristone in Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine. We are concerned that upholding the Fifth Circuit’s decision would create new challenges in the regulatory framework for drug approvals and access to medicines in the United States. These cases remind us of the importance of the Food and Drug Administration’s (FDA) rigorous, well-established scientific process to assess the safety, effectiveness, and quality of medicines and trust in the broader regulatory framework that helps ensure their quality.

USP is concerned about any threats that could upend the FDA’s scientific decision-making. The U.S. Pharmacopeia’s (USP’s) expert committees work closely with FDA’s government liaisons—leveraging collective scientific expertise—to establish the USP public quality standards that are relied upon by industry, regulators at the federal and state level, and trusted by patients. Undermining FDA undercuts this and many other downstream aspects of the regulatory framework that have fostered the availability of high-quality medicines that are a hallmark of U.S. healthcare. USP continues to stand behind the FDA’s independent, scientific approval process for safe and effective medicines.

The FDA plays an essential role in protecting public health by evaluating the safety and efficacy of medicines. Since 1906, USP has collaborated with the FDA to ensure appropriate quality standards of FDA-approved products. Medicines sold in the United States generally must adhere to USP’s public quality standards to help ensure the quality of medicines and the safety of patients.

USP standards and solutions are rooted in science and developed in an open, transparent process by world-class scientists in collaboration with global health advocates, academia, government, and industry leaders. This process offers the ability to adjust standards to confront public health emergencies, adapt to new industry practices, and keep up with evolving science and technology. Their purpose is to foster development, manufacture, and delivery of medicines; facilitate regulatory approval; support post-market quality surveillance; and enhance public trust in the quality of medicines.

USP’s mission is to protect the quality, availability and safety of medicines for people around the globe. This decision threatens the potential safety and availability of medicines for people seeking medical treatment for abortion and could have concerning ripple effects throughout the industry. As an organization, we believe that scientific evidence, validated and assessed by qualified agencies like the FDA, should be the basis of decisions on patient access to medicines.