Access to mifepristone was once again on the local docket, with representatives from the Center for Reproductive Rights and the Food and Drug Administration presenting oral arguments on May 19 in the U.S. District Court for the Western District of Virginia in Charlottesville.
The suit, filed by Whole Woman’s Health Alliance in May 2023, challenges federal restrictions on mifepristone, one of the most common abortion medications in the United States.
“I think it’s really important to make sure there aren’t restrictions on medication abortion that are politically motivated, but that the FDA pays attention to the science and the evidence,” says Amy Hagstrom Miller, president and CEO of Whole Woman’s Health.
The plaintiffs—WWHA, Trust Women in Kansas, and All Families Healthcare and Blue Mountain Clinic in Montana—assert the current regulations are medically unnecessary and restrict patient and prescriber access to the time-sensitive medication.
“What we’re trying to do is get Virginia, Montana, and Kansas to get the same protections that are already in place in what’s often referred to as the Washington Brief,” says Miller.
Similar to the WWHA suit, Washington et al v. U.S. Food and Drug Administration was filed in 2023 in an effort to reduce nonmedical restrictions on mifepristone. The U.S. Ninth Circuit Court of Appeals found in favor of the plaintiffs in July 2024, expanding and protecting access to the medication in 17 states and Washington, D.C.
“We’re asking for the FDA to take a look at what’s called the REMS, which are these special restrictions that are connected to mifepristone that really aren’t based on the health and safety of mifepristone, and asking them to take a look at the evidence that’s come in in the last 25 years since mifepristone was first approved, and be sure it’s not restricted unduly,” says Miller.
In addition to abortion care, mifepristone is commonly used to manage miscarriage. WWHA v. FDA challenges the Patient Agreement Requirement, which mandates patients sign a statement reading “I have decided to take mifepristone and misoprostol to end my pregnancy” prior to receiving the medications. The form is required for both abortion and miscarriage management, and is added to patients’ medical records.
On the provider side, the suit argues that the current requirement for medical professionals to register with the drug manufacturer before prescribing mifepristone “deters qualified providers from prescribing the medication out of fear that registration could expose them to anti-abortion violence or harassment.” The case also examines current restrictions on pharmacies that dispense the medication, which are regulated similarly to providers.
If an opinion is issued in favor of the plaintiffs, Virginia, Kansas, and Montana would be protected from potential restrictions on mifepristone at the federal level.
“It just feels incredibly poignant at this point in time,” says Miller, “especially in light of what [Health and Human Services Sec. Robert F. Kennedy, Jr.] talked about … taking a look at the FDA approval of mifepristone.”
At press time, an opinion has not been issued in the case. Access to medication abortion remains unrestricted in Virginia.—Catie Ratliff
Amy Hagstrom Miller founded Whole Woman’s Health, now headquartered in Charlottesville, in Austin, Texas, in 2003. Photo: Amy and Jackson Smith.
