In states without additional restrictions “the significance could be quite enormous,” one expert says
Mifepristone was first approved by the FDA more than 20 years ago, but it has been subject to a number of arbitrary restrictions, known as a risk evaluation and mitigation strategy, or REMS, since 2007. Under those rules, doctors were not allowed to write a prescription unless they obtained an additional certification specifically for prescribing mifepristone, and patients were forced to pick-up the mifepristone from that provider in person.
The fatality rate for the erectile dysfunction drug Viagra, for example — which is not subject to REMS — is six times higher than mifepristone’s. According to the ACLU, which represented the plaintiffs in the case, mifepristone was the single medication — out of 20,000 FDA-approved drugs — that required patients pick it up at a medical facility, regardless of where they ultimately took the drug.
“With states banning abortion at earlier and earlier points in pregnancy, it is all the more essential that the FDA remove medically unnecessary restrictions that reduce where and how patients can safely fill their mifepristone prescription — and today’s decision is critical progress, though far from complete,” added Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project and counsel for plaintiffs.
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