Former FDA Officials Argue Fifth Circuit’s Mifepristone Decision Would Engender Regulatory Chaos

Allowing courts to overturn science-driven drug approval decisions would open the door to a myriad of partisan legal challenges, exert a chilling effect on the business of drug development, and endanger patients, according to an amicus brief on the Fifth Circuit’s mifepristone restriction decision, filed by seven former FDA commissioners and acting commissioners.

“Opening each of these judgments up to fresh review by courts would supplant this rational, evidence-based drug regulatory scheme with a chaotic patchwork susceptible to endless legal challenges and inconsistent outcomes,” the brief says.

The brief relates to the case before the Supreme Court following the decision of the U.S. Court of Appeals for the Fifth Circuit to retroactively “stay” regulatory actions taken by the FDA since 2016 relating to prescribing and dispensing the medication and joins 35 others filed a few days ago.

Read the brief here.

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