“Specifically, providers want the FDA and U.S. Department of Health and Human Services to abandon the set of restrictions known as a Risk Evaluation and Mitigation Strategy (“REMS”), which has applied to mifepristone since it was approved 23 years ago,” according to Whittney Evans. “REMS regulates mifepristone in a similar way to chemotherapy drugs, which providers argue is unnecessary and misleading.”
What the providers ultimately want “is for the federal government to remove the REMS designation entirely,” Evans continued. “In the meantime, they’ve asked District Judge Robert S. Ballou for a preliminary injunction to prevent further restrictions and maintain the status quo.”