Potential Supreme Court Mifepristone Case Sees PhRMA File Amicus Brief

PhRMA has asked the U.S. Supreme Court to grant petitions from the Department of Justice (DOJ) and Danco Laboratories and reverse the U.S. Court of Appeals for the Fifth Circuit judgment on Mileprex (mifepristone) because it “sets a precedent that — if left undisturbed — could significantly disrupt industry and stifle innovation in drug development.”

In its brief filed Thursday, PhRMA explained that “FDA’s safety determinations will risk becoming mere precursors to litigation, rather than durable decisions that protect a company’s massive investment in the product’s lengthy research and development process,” adding that the Fifth Circuit’s “ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations.”

Last month, DOJ and Danco Laboratories, manufacturer of Mifeprex, asked the Supreme Court to review the Fifth Circuit court’s decision to limit access to the abortion drug.

Read PhRMA’s amicus brief here.

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