Abortion Pill Mifepristone Will No Longer Require In-Person Pick Up, US FDA Concludes
REMS modification implemented for the duration of the pandemic will become permanent, the agency determines in response to lawsuit. FDA adds a requirement that pharmacies dispensing the drug be certified.
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HHS report on protecting reproductive care shows administration is reluctant to take bold actions to counter Supreme Court’s Dobbs decision. Report does not suggest revising or eliminating mifepristone’s REMS or seeking preemption legal battles as some advocates have urged.
GenBioPro, which markets a generic version of the medical abortion product, may pursue litigation in a more favorable jurisdiction than the Mississippi district court where the case had been proceeding. Senators ask HHS to consider filing its own suit to enforce federal preemption of state laws, lifting REMS restrictions and having FDA issue an EUA for misoprostol.
Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.