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US FDA’s Califf Responds To, And Deflects, Senators’ Mifepristone Questions

Executive Summary

The Senate Appropriations Subcommittee hearing was called to discuss the agency’s FY 2024 budget request, but several committee members wanted to talk about the pending Supreme Court decision on the medication abortion drug.

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Supreme Court’s Stay Of Mifepristone Ruling Gives FDA Respite For Next Round

Medication abortion pill can remain on the market under current conditions until appeal on the merits of the preliminary injunction is decided. Justice Alito dissents, noting that FDA could exercise its enforcement discretion to prevent harm to mifepristone manufacturer Danco.

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After sitting out the initial rounds, trade group backs FDA’s decisions on the medication abortion pill and asks Supreme Court to stay Texas district court ruling suspending the drug’s approval.

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Supreme Court stays Texas district court’s order until 19 April. FDA’s deputy principal commissioner says if it goes into effect, sponsors will have to submit additional applications, prescribers may need to be recertified, and FDA will have to reinstate higher dosing regimen.

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