By The Epoch Times | Created at 2026-07-27 18:01:40 | Updated at 2026-07-27 20:09:50
2 hours ago
A federal judge has ruled that the Food and Drug Administration’s 2023 restrictions on the abortion drug mifepristone are “arbitrary and capricious,” ordering the agency to better justify rules requiring special certification for prescribers and pharmacies.
The two drugs mifepristone and misoprostol together make up the most common abortion regimen in the United States.
On July 23, U.S. District Judge Robert Ballou in Charlottesville, Virginia, said the FDA had failed to explain why the requirements adopted in 2023 were necessary, after the agency had repeatedly affirmed mifepristone’s safety and effectiveness.
The suit, filed in 2023 by abortion advocates Whole Woman’s Health Alliance and other abortion providers in Virginia, Kansas, and Montana, challenged the FDA’s 2023 mifepristone restrictions as unwarranted under federal law, as they require prescribers and dispensing pharmacies to be specially certified and require patients to sign a written acknowledgment of the drug’s risks.
“Nor does the FDA explain how, without these restrictions, prescribing the drug becomes an intolerable risk which would require withdrawal of the drug from the market,” wrote Ballou.
In a 48-page opinion, Ballou wrote that “the FDA has steadfastly found, over the past quarter century, that mifepristone is a safe and effective medication,” yet its 2023 rationale “does not identify the risk alleviated by the restrictions.”
The restrictions remain in effect for now, and Ballou remanded the case to the FDA rather than vacating the rule.
The FDA approved mifepristone in 2000 and has gradually expanded access, including under a Biden-era policy allowing the drug to be prescribed and dispensed by mail. In May, the U.S. Supreme Court allowed that policy to remain in effect while a legal challenge is paused pending the FDA’s review.
As part of a broader review, some pro-life groups have urged President Donald Trump to reinstate the in-person rule for safety reasons and to prevent men from accessing the pills without their partners’ knowledge.
The FDA said in an April 8 update that it has been moving ahead with a safety study of mifepristone.
It said that once the FDA finishes its analysis of the data, the agency will “decide whether to make substantive changes” to the Risk Evaluation and Mitigation Strategy (REMS).
A drug is placed on a REMS program to ensure that the benefits of the drug outweigh the risks of the drug.
It said that if the FDA determines “that changes to the REMS are warranted, then the agency will take appropriate action.”
Nancy Northup, president and CEO at the Center for Reproductive Rights, a pro-abortion organization that represents the providers who sued over the 2023 rule, said in a July 24 statement that mifepristone is an “essential drug” which it claims “is in grave danger of being severely restricted or even taken off the market nationwide.”
Linda Goldstein, senior counsel at the Center for Reproductive Rights, said these restrictions “prohibit providers and pharmacies from prescribing or dispensing mifepristone without special registration and certification.”
“They also require patients to sign duplicative, inaccurate, and confusing paperwork. It’s time to get rid of these senseless requirements,” she added.
National Right to Life, the country’s largest national anti-abortion organization, said in a July 27 statement that the court had simply told the FDA to “explain itself more fully.”
“That is far different from proving that the restrictions lack a medical purpose,” it said.
“The claim that mifepristone is ‘exceedingly safe’ also deserves scrutiny. A 2023 population-based study of women in Ontario, published in the Annals of Internal Medicine, found that 10.3 percent of women who underwent chemical abortions visited an emergency department afterward,” it said.
It said that mifepristone works by blocking progesterone, the hormone that sustains pregnancy.
“Misoprostol then causes contractions to expel the developing child.”
“The regimen does not merely carry a risk of ending a human life. Ending that life is its intended purpose. No discussion of ‘safety’ can honestly ignore the unborn child. A successful chemical abortion always ends in death for that child,” it added.
Reuters, Stacy Robinson, Zachary Stieber, and Mimi Nguyen Ly contributed to this report.
