For the past eight years, CAFP has been represented by the American Civil Liberties Union as a plaintiff in litigation challenging the Food and Drug Administration’s medically unjustified restrictions on mifepristone, a safe medication used in most abortions and for miscarriage care. On October 30, a federal court ruled that the FDA violated federal law when imposing its current restrictions on mifepristone.
“As front-line physicians who provide preventive and primary care for the whole family, family physicians fight for patient access to safe and effective treatments,” said Lisa Folberg, MPP, CAFP CEO. “The FDA's needless restrictions on mifepristone restrict access without any safety benefit. For eight years, CAFP has been fighting for an FDA policy on medication abortion grounded in science, not politics or stigma. This decision is a step in the right direction.”
While this ruling does not change patients’ ability to access medication abortion in the near term, it comes at a critical moment — as Health and Human Services Secretary Kennedy has directed a new review of the FDA's mifepristone regulations and signaled that it intends to add even greater restrictions. The court's order means that the FDA will now have to consider the wealth of peer-reviewed evidence proving mifepristone’s safety, including when delivered by telemedicine, and how its restrictions on mifepristone burden both patients and health care providers.
In 2021, this litigation prompted the FDA to reconsider its in-person dispensing requirement for mifepristone in light of the significant evidence that mifepristone is just as safe when dispensed through a pharmacy and that the in-person requirement severely burdened patient access. While the FDA suspended and then formally eliminated its telemedicine restrictions for mifepristone, it continued to single out mifepristone prescribers, pharmacists, and patients with medically unnecessary restrictions that severely limit patients’ ability to access medication abortion. The evidence in this case showed that the FDA already regulates mifepristone more heavily than 99 percent of prescription medications.
For additional resources related to medication abortion, please visit www.familydocs.org/rhi.
