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New ruling out of Texas sets "dangerous precedent for undermining the FDA"

BIO interim President and CEO, Rachel King, responds to the court's decision to suspend the FDA’s approval of mifepristone.

April 8, 2023
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A federal judge in Texas rules this week to suspend the FDA’s approval of mifepristone. BIO interim President and CEO, Rachel King, released the following statement: 

“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations. 

“This decision has ramifications that extend well beyond this case, setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies. 

“As this case works its way through the appeals process, it is our hope that this ruling is overturned, so that patients and drug developers can rely on the rigorous FDA approval process as the scientific and trusted standard for drug approvals. 

“We are seeing amazing breakthroughs in labs across the country. We are on the cusp of groundbreaking new medicines that will transform the standard of care for our loved ones. We need a regulatory, legal and policy environment that reflects the needs of these patients, respects the expertise of our nation’s leading scientists and protects the ecosystem that allows medical breakthroughs to go from the bench to a patient’s bedside.”

 

 

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