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  • Press Release

    AAMC Statement on Court Opinion Undermining FDA Regulatory Authority

    Media Contacts

    John Buarotti, Sr. Public Relations Specialist

    AAMC (Association of American Medical Colleges) President and CEO David J. Skorton, MD, and Chief Scientific Officer, Ross McKinney Jr., MD, issued the following statement on the U.S. District Court for the Northern District of Texas’s decision to invalidate the approval of the drug mifepristone by the U.S. Food and Drug Administration (FDA) and its impact on access to comprehensive reproductive health care:

    “The AAMC is profoundly concerned by the court opinion that seeks to undermine the FDA’s robust and decades-old process for determining whether drugs are safe and effective. The scientific review and regulatory decision-making process is now and must remain the purview of the federal agency that has been given specific authority for the oversight of drugs – not the judicial branch.

    The Texas court’s actions suggest that any court might seek to second-guess the FDA’s scientific expertise and regulatory process to unilaterally revoke approval of any drug, even those that had been successfully and safely used for decades such as mifepristone.

    The level of uncertainty this type of judicial overreach will create is untenable and could damage the ability of health care providers to prescribe medications with the confidence that they would continue to be available in the future. This would jeopardize the health and well-being of all patients and interfere with the practice of evidence-based medicine.

    This opinion specifically limits access to medication that is part of the full range of reproductive health care services. If allowed to remain in place, the court’s decision will increase the burden on historically and economically marginalized and disadvantaged populations, increase health inequities across the country, and ultimately put lives at risk.”  

    The AAMC (Association of American Medical Colleges) is a nonprofit association dedicated to improving the health of people everywhere through medical education, health care, medical research, and community collaborations. Its members are all 158 U.S. medical schools accredited by the Liaison Committee on Medical Education; 13 accredited Canadian medical schools; approximately 400 academic health systems and teaching hospitals, including Department of Veterans Affairs medical centers; and more than 70 academic societies. Through these institutions and organizations, the AAMC leads and serves America’s medical schools, academic health systems and teaching hospitals, and the millions of individuals across academic medicine, including more than 193,000 full-time faculty members, 96,000 medical students, 153,000 resident physicians, and 60,000 graduate students and postdoctoral researchers in the biomedical sciences. Following a 2022 merger, the Alliance of Academic Health Centers and the Alliance of Academic Health Centers International broadened participation in the AAMC by U.S. and international academic health centers.