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SCOTUS should preserve FDA's "mandated authority" and "scientific and medical expertise" in new case

December 13, 2023
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Today, the Supreme Court announced it will soon weigh in on a case that challenges how the Food and Drug Administration (FDA) regulates mifepristone, a drug it approved almost 25 years ago. BIO interim president and CEO, Rachel King, made the following remarks:

“The unprecedented suspension of mifepristone -- a drug that had been approved by the FDA and on the market for nearly 25 years -- earlier this year was a significant overreach of the courts and a major disservice to patients relying on biomedical innovation. 

"Preserving and protecting the FDA's authority to make determinations about the approval of lifesaving and life-enhancing therapies has been -- and will continue to be -- critically important to both ensuring it is able to meet its mission to protect and promote the public's health and to ensuring there are clear paths forward for new waves of innovation for patients suffering from a wide range of illnesses. The FDA has not only the mandated authority, but also the scientific and medical expertise that has established the agency as the best in the world. Undermining this authority and expertise would create within the biomedical industry massive uncertainty and significant barriers to advancing the next wave of innovation. 

"We are pleased the Supreme Court will soon hear this important case. As we have warned repeatedly, this decision has long-term ramifications that extend well beyond a single drug. We will continue fighting on behalf of patients and our member companies to ensure groundbreaking scientific ideas in labs have the opportunity to benefit our neighbors and loved ones for years to come."

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