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FDA Regulatory Authority Under Attack

April 10, 2023


In an unprecedented ruling, last week a federal judge in Texas suspended FDA’s approval of mifepristone (Mifeprex), declaring that the agency had not sufficiently assessed the safety and efficacy of this widely used abortifacient. Judge Matthew Kacsmaryk stated that FDA ignored demonstrated safety concerns and relied on “unsound reasoning and studies” in the face of “significant political pressure” to increase access to chemical abortions. FDA approved the drug 20 years ago.

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