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.”