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.
Key Takeaways
- FDA and pharma will likely once again be forced to defend the sanctity of the FDA's approval process in court due to the revival of an abortion pill case in Texas.
- Given prior rulings from the Texas court and the Fifth Circuit, the case is likely to wind back up at the Supreme Court. A pending circuit split, with ongoing litigation in the Ninth Circuit is also likely
In June, the US Supreme Court ruled the Alliance for Hippocratic Medicine (AHM) did not have standing to challenge FDA’s 2016 and 2021 actions that loosened mifepristone’s REMS, sending the case back to district court. The REMS changes made the drug more easily accessible and available later in pregnancy, and the
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