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Biopharma Companies – But Not PhRMA – Argue That Mifepristone Ruling ‘Radically Alters’ NDA Process

 
• By Brenda Sandburg

BIO signs on while PhRMA and AAM stay on the sidelines as 169 companies, executives and investors file amicus brief supporting FDA’s request for stay of Judge Kacsmaryk’s decision to halt approval of the medication abortion drug. Members of Congress file opposing briefs.

Mifepristone
Biopharma companies aska appeals court to stay mifepristone ruling against FDA • Source: Shutterstock

The biopharma industry joined the legal battle over a Texas court ruling staying the US Food and Drug Administration’s approval of mifepristone. A group of 169 companies, senior executives, board members and investors asked the US Court of Appeals for the Fifth Circuit to stay, and ultimately reverse, the district court’s order, arguing that it would result in a “seismic shift” in the clinical development and drug approval process and that thousands of drugs would likely not have been approved under the court’s “groundless approach.”

The group filed an amicus brief on 11 April in support of motions by FDA and Danco Laboratories requesting a stay of District Judge Matthew Kacsmaryk’s order pending appeal....

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