Late last week, the U.S. Supreme Court granted an extended stay pending the appeal of a case currently in the 5th Circuit Court seeking to repeal the Food and Drug Administration’s (FDA) now 20-year-old approval for the drug mifepristone. As this case makes its way through the appeals process, the American College of Preventive Medicine implores the justices to uphold the regulatory authority and the longstanding, nonpartisan, scientific integrity of the FDA.
Accepting the lower court ruling would have disastrous consequences for the FDA and millions of patients who rely on this essential, potentially life-saving medication approved by the agency for women’s reproductive health. The FDA ensures all products under its regulatory purview undergo extensive and thorough testing by teams of dedicated scientific and medical professionals with expertise in medicine, clinical development, regulatory affairs, pharmacology and other relevant fields. Allowing the courts to usurp their decisions and placing the power to regulate medical products in the hands of a judiciary untrained in science and medicine would set a dangerous precedent.
Beyond mifepristone, future challenges of this nature could see the courts revoking FDA approval of vaccines, anti-depressants, oncology medications and more. Millions of patients who rely on these products would be left without the lifesaving treatments and prevention they need. The public health impact would be extremely negative.
Thus, the College urges 5th Circuit Court and the Supreme Court to support the Food and Drug Administration’s well-established expertise and regulatory authority in the coming rulings.