If a 5th U.S. Circuit Court of Appeals ruling is ultimately allowed to stand, physicians would no longer be allowed to prescribe or dispense mifepristone via telemedicine or through the mail, and non-physicians would no longer be allowed to prescribe the drug.
The AMA says it’s a decision that would reinstate barriers that impede access to mifepristone without scientific evidence to support restrictions on a medication that gained approval from the Food and Drug Administration (FDA) in 2000 and has been proved to be unquestionably safe and effective to terminate pregnancies and to medically manage miscarriages for more than two decades. The drug also is increasingly used to treat conditions that are not pregnancy related.
The appeals court decision “continues to signal a move in the wrong direction on access to mifepristone,” said Jack Resneck Jr., MD, the AMA’s immediate past president. “While this decision preserves the original approval of Mifeprex and generic mifepristone, this action will undoubtedly negatively impact patients across the country if left in place.”
For now, physicians won’t have to change the way they are practicing medicine and patients in states where abortion is legal will continue to have access to mifepristone. That is thanks to an earlier April order in the case, Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., in which the U.S. Supreme Court said the current rules will stay in place while appeals in the case make their way through the court system. The U.S. Justice Department said it will appeal the most recent 5th Circuit decision to the Supreme Court.
The AMA has filed several briefs with other medical organizations telling the courts that mifepristone is safe and that taking away access to the medication would harm patients.
“Research shows an association between restricted access to safe and legal abortion and higher rates of maternal morbidity and mortality, with already vulnerable populations experiencing the greatest burden,” Dr. Resneck said.
The 5th Circuit’s opinion
In the wake of the Supreme Court’s Dobbs decision, the Alliance for Hippocratic Medicine filed the lawsuit on behalf of itself and member groups, including the Catholic Medical Association, Christian Medical Association, Dental Association and others that oppose abortion.
These groups claim the FDA’s initial approval process for mifepristone was inappropriate and that rules that allowed expanded access to the medication in later years didn’t protect the health and safety of women and girls. For example, 2016 rule changes, among other things, allowed non-physicians to prescribe mifepristone and changes in 2021 allowed the medication to be prescribed remotely.
The 5th Circuit Court of Appeals ruled that mifepristone can remain available under the safety restrictions that were in effect before 2016. However, the court was persuaded by testimony from doctors who said they treated patients who had complications after taking mifepristone and upheld a lower court ruling that said the medication can’t be prescribed by a non-physician or without a patient meeting with a physician in person.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the appellate court said in its ruling.
AMA’s evidence-based medicine fight
The AMA disagrees with the court’s assessment. Dr. Resneck said the FDA approval process is “based on extensive, evidence-based scientific review of efficacy and safety.”
An AMA Leadership Viewpoints column and Dr. Resneck's op-ed in The New York Times explains more about what is at stake in this case.
Meanwhile, a case that attorneys general in 17 states and the District of Columbia filed in February seeking to make mifepristone easier to access by challenging some FDA restrictions continues to work its way toward a decision in the U.S. District Court for the Eastern District of Washington.
