U.S. Pharmacopeia Issues Statement on the Decision to Suspend FDA Approval of Mifepristone in the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration Case

Rockville, MD, April 10, 2023 - The U.S. Pharmacopeia (USP) today issued a statement on the US District Court for the Northern District of Texas decision to suspend the U.S. Food and Drug Administration (FDA) approval of Mifepristone in the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration case:

USP stands by the FDA’s assessment of the safety, effectiveness, and quality of mifepristone. Mifepristone was approved by the FDA in 2000 and has been used safely by women for medication abortion for 23 years. USP has collaborated with the FDA since the agency’s establishment in 1906 and concurs with leading stakeholders from the health and science community that FDA remains the world’s leading national regulatory agency for medicines.

“USP stands by the principle that science, not politics, should drive decision-making when it comes to the health of the women of America and people everywhere,” said Ronald T. Piervincenzi, PhD, Chief Executive Officer, United States Pharmacopeia. “USP believes that when decisions on access to medicines are made on political considerations rather than science, public trust in the medicine supply rapidly erodes. Scientific evidence, validated and assessed by qualified agencies like the FDA, should be the basis of decisions on patient access to medicines.”

About USP
USP is an independent, non-profit organization that develops science-based public quality standards that articulate quality requirements for medicines marketed in the United States and dozens of countries that recognize USP standards. USP standards for medicine quality are established by committees of experts from the scientific, healthcare practitioner, and academic communities who volunteer their time and expertise, working alongside over 200 FDA scientists. Through our resources, standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and foods for billions of people worldwide.