risk and evaluation mitigation strategy (REMS)

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The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA) approval of mifepristone. Throughout the questioning, the Justices focused on both the standing of the plaintiffs to bring the cases and on the suitability of the remedy sought.

The Court is expected to rule on the case in late June or early July. Although the Court has a 6-3 majority of justices appointed by Republican presidents, the questioning by the justices and the areas that they focused on seemed to indicate that any judicially-imposed limitations on both the FDA’s approval of the drug and the FDA’s current restrictions on the dispensing of mifepristone may be narrow.

At different times during the argument, both liberal and conservative Justices mixed together in the thrust of their questions in a way that could result in this case being a close decision with many different opinions or even resulting in a majority decision that would allow continued dispensation of the drug due to standing considerations.Continue Reading SCOTUS Arguments on Mifepristone Cases Focus on Standing and Remedy

UPDATE: Late in the evening of September 28, the House defeated H.R. 4368 by a vote of 191-237, with 27 Republicans voting against the bill. It was the only one of the four appropriations bills to fail.

Editor’s Note: This post was originally published at 11:15 PM EST on September 27, 2023 while the House of Representatives was still voting on amendments to other appropriations bills.

A group of conservative Republicans in the House of Representatives’ proposed Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 (H.R. 4368) would rescind the Food and Drug Administration (FDA)’s January 2023 change to the Risk Evaluation and Mitigation Strategy (REMS) program to allow certified retail pharmacies to dispense mifepristone as part of a medication abortion regimen. The proposal would effectively limit retail pharmacy dispensing of the only medication that is labeled for medication abortion.Continue Reading GOP House Bill Proposes Repeal of Retail Pharmacy Dispensing of Mifepristone