A call to end the excessive regulation of mifepristone
Approximately one in four abortions taking place in the U.S. are now medication abortions. One of the most commonly used abortion drugs, mifepristone, is subject to a special set of burdensome FDA restrictions known as a Risk Evaluation and Mitigation Strategy (REMS). In a recent New England Journal of Medicine commentary, a group of experts including the Bixby Center’s Dan Grossman called on the FDA to eliminate the mifepristone REMS.
REMS restrictions not only make mifepristone harder to find—for example, by prohibiting its sale by retail or mail-order pharmacies—but also make it unappealing to prescribe. Eligible prescribers must jump through extra hoops that dissuade many from offering the drug. As a result, mifepristone is being underutilized, especially as a way to better serve women in areas with severe abortion provider shortages.
The evidence shows that mifepristone is just as safe as many other drugs and procedures that the FDA does not regulate as heavily. More than 3 million women have used mifepristone in the 16 years since the FDA approved it, and it has proven far safer than childbirth. Its most common side effects are also similar to those caused by other less regulated drugs and procedures.
The excessively burdensome REMS regulations placed on mifepristone are not only unhelpful, but they are harmful to women who already face many barriers to safe, easy abortion access.