Déjà Vu: Revived Mifepristone Case Puts FDA And Pharma At Risk Again

The outcome of the November presidential election may impact whether the government is willing to defend FDA's relaxation of the mifepristone REMS. The case poses risks for the broader drug approval process.

Three pill bottles of mifepristone.
Litigation over abortion pill mifepristone once again puts the entire FDA approval process at risk. (Shutterstock)

Three US states are attempting to intervene in a lawsuit that seeks to roll back changes the Food and Drug Administration made to the abortion pill mifepristone’s Risk Evaluation and Mitigation Strategy, a move that puts the entire agency’s drug approval process – and the pharmaceutical industry that relies upon the certainty of the status quo – in jeopardy, again.

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