Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says

If ruling against US FDA by 5th Circuit is enacted, access to the medication abortion would revert to pre-2016 restrictions, meaning the product would be indicated for a maximum gestational age of forty-nine days and would need to be administered in person.

Mifeprex
• Source: Shutterstock

The mifepristone ruling by the United States Court of Appeals for the Fifth Circuit on 16 August is by no means the last word on access to medication abortion, but it could end up being a definitive one nonetheless.

The appeals court ruling concluded that the REMS modifications that FDA enacted in 2016 – which raised the gestational...

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