A U.S. District Judge out of Virginia has ruled that safety regulations placed on the abortion pill mifepristone are "unlawful" and ordered that the Trump administration reconsider them.

In the ruling, Judge Robert S. Ballou said the Food and Drug Administration (FDA) failed to explain why its 2023 REMS safety requirements for the abortion pill mifepristone (200mg)/Mifeprex were necessary, calling the rules "arbitrary and capricious." The 2023 change eroded in-person dispensing for the drug to allow for mail-order and pharmacy dispensing despite the risks associated with it.

Key Takeaways:

• A U.S. District Judge ruled that REMS safety regulations on the abortion pill mifepristone are "unlawful."

• He ordered the Trump administration to reconsider them.

• The safety requirements, however, are necessary because the abortion pill carries significant risks to women, and underreporting of complications has only made it appear safe.

The Backstory:

The abortion pill, mifepristone (200mg)/Mifeprex, was approved by the FDA in 2000 and placed under a safety system known as REMS in 2011.

2016: Big Abortion conspired to erode the REMS on the drug, and the Obama FDA weakened the REMS, even removing the requirement to report the drug's adverse events other than deaths. The decision to halt the reporting of non-fatal adverse events (complications) of the abortion pill in 2016 may have led to the faulty conclusion that the drug is safe.

2023: Despite a prohibition under the federal Comstock Act, Biden's FDA weakened the REMS again to remove the in-person dispensing requirement and to allow for mail order and pharmacy dispensing of the drug.

June 2026: A senior FDA official confirmed that the promised safety review of mifepristone was moving forward, and could be completed within months, with some speculating it could happen by September of this year.

The Details:

Pro-life states like Louisiana contend that the 2023 REMS change that allows mail-order dispensing of the abortion pill trampled their laws protecting preborn children. They have filed multiple lawsuits, some of which are on hold pending the FDA's review of mifepristone.

Virginia Case

Whole Woman's Health v. U.S. Food and Drug Administration (FDA) is a case currently before the United States District Court of the State of Virginia. Whole Woman's Health is "a collection of health care providers and clinicians that prescribe mifepristone."

"At stake were a set of rules called Risk Evaluation and Mitigation Strategy (REMS), long criticized by abortion advocates as unduly burdensome," wrote MedicalExpress.com. "[The judge] ordered the Trump administration to reconsider the rules but did not void them or find that the FDA...had acted illegally in principle by trying to impose safety restrictions."

From Judge Ballou's opinion:

The 2023 REMS imposed by the FDA on mifepristone require that (1) prescribing pharmacies be specially certified, (2) prescribing clinicians be specially certified, and (3) prescribers and patients sign a form acknowledging the treatment and its risks.

Abortion providers in Virginia, Kansas, and Montana brought this case to challenge the 2023 REMS as excessively restrictive, unwarranted, and inconsistent with the requirements of the Federal Food, Drug, and Cosmetic Act of 1938.

...The FDA failed to consider relevant data, analyze restrictions with reference to the mandated statutory factors, or provide a reasonable justification for its 2023 REMS modification.

It stated that the goal of the REMS is “to mitigate the risk of serious complications associated with mifepristone," and that "[t]he FDA is directed to determine if a REMS is necessary to ensure that a drug’s benefits outweigh its risks."

It included several factors:

Prescriber certification requires providers to certify they

1. can accurately assess pregnancy duration,

2. can diagnose ectopic pregnancies,

3. can provide surgical intervention in instances of severe bleeding or incomplete abortions, or have established plans to provide such care through others and be able to assure access to medical facilities equipped to provide resuscitation and blood transfusions, and

4. have reviewed and understood the mifepristone prescribing information.

Important note: abortion pill prescribers are certified and policed by abortion pill manufacturers Danco Laboratories and generic manufacturers GenBioPro (GBP) and Evita Solutions, but as Live Action News previously documented, prescribers who flout FDA's REMS are not being decertified.

For example, Plaintiff Whole Woman’s Health offers the abortion pill up to 12 weeks, which is beyond the FDA’s 10-week gestational limit; however, nothing is being done to stop it from prescribing the drug two weeks beyond the FDA-approved limit.

Pharmacy certification requires pharmacies to attest, among other things:

1. that the prescriber is certified in the mifepristone REMS program,

2. that the pharmacy will dispense mifepristone so that it's delivered within 4 days of receipt of the prescription, or if delivery is later, confirm with the prescriber that it is still appropriate to dispense the drug,

3. that the pharmacy will track, verify, and maintain records of each mifepristone shipment, and

4. that the pharmacy will comply with mifepristone manufacturer audit requests

The plaintiffs in the case alleged the FDA said the new pharmacy certification requirement is necessary because the in-person dispensing requirement was removed, but failed to state how the two requirements were "interrelated." The plaintiffs claimed that the "FDA acknowledged that it had not considered any data addressing pharmacy certification specifically."

The arguments

According to the opinion, the plaintiffs argued that the "2023 REMS unduly burden patient access to mifepristone and are not supported by scientific evidence. Plaintiffs also bring an equal protection claim under the Due Process Clause of the Fifth Amendment contending that the 'FDA treats providers, pharmacists, and patients who prescribe, dispense, or use mifepristone worse than providers, pharmacists, and patients who prescribe, dispense, or use nearly every other medication.'” They also claimed that the “FDA reevaluated the provisions of the mifepristone REMS in 2016, and again in 2019, 2021, and 2023, but it has continually decided to reimpose the REMS despite longstanding objections from the medical community and its own review of the data showing mifepristone’s safety and efficacy.”

Ballou further explained that WWH alleged that the REMS "directly injure them by causing delays in their certification of new hires, and generating significant administrative burdens including alleged unnecessary recordkeeping, patient agreement form translation and distribution challenges, and self-stocking of mifepristone given limitations placed on pharmacies certified to distribute the drug."

Meanwhile, the judge noted that the FDA "contends that Plaintiffs lack standing and failed to exhaust their administrative remedies, preventing the Court from reaching the merits of their claims....Defendants argue that Plaintiffs failed to exhaust their administrative remedies because they did not file a citizen petition, depriving the FDA a chance to address their claims. They also contend that Plaintiffs failed to show that using the administrative process would have been futile." Ballou also wrote that the FDA said it "has repeatedly affirmed that REMS requirements for mifepristone were reasonable and necessary to ensure the drug’s safe use for medication abortion."

Ballou continued:

Accordingly, Plaintiffs have standing to pursue their claims.

...the heart of Plaintiffs’ challenge echoes the longstanding efforts of various organizations that urged the FDA to lift the REMS requirements for mifepristone, arguing the drug is safe without them. Time and again, the FDA has declined to do so.

...Considering this regulatory history, the FDA cannot plausibly claim that a new citizen petition would change its position that, despite the proven safety of mifepristone, the REMS remain necessary for its use to terminate a pregnancy. I therefore find that requiring further exhaustion through a citizen petition would be futile.

Judge's Ruling

In his July 23, 2026 opinion, Judge Ballou ruled the 2023 "REMS modifications are arbitrary and capricious." The Judge also ruled that "Plaintiffs’ claim that the Agency exceeded its statutory authority (Count I) is DISMISSED."

The judge wrote:

Plaintiffs argue that the FDA’s 2023 REMS Modification Rationale is arbitrary and capricious as a matter of law because the FDA (1) failed to provide a satisfactory explanation for its decision and (2) excluded relevant data.

I agree.

...The Court does not assess whether the 2023 REMS are in fact necessary to ensure that mifepristone’s benefits outweigh its risks or to reduce the burden on the healthcare system. Instead, the court reviews the FDA’s actions to determine whether its decision-making process provided an adequate basis to support its conclusions.

I find that the FDA’s analysis in support of the 2023 REMS fails to provide an adequate explanation of the reasoning behind its conclusions. As a result, the agency’s decision to require the 2023 REMS is arbitrary and capricious under the APA.

His rationale was that over the last 25 years, the FDA has consistently found mifepristone to be safe and effective at ending preborn lives and that the explanation for the pharmacy certification and other REMS requirements does not identify what risk is alleviated by the REMS rules. He also wrote that the FDA did not explain how mifepristone is an "intolerable risk" without the REMS that would ultimately "require withdrawal of the drug from the market."

He concluded that the FDA's "failure to consider relevant evidence and provide a reasoned explanation renders the 2023 REMS modification arbitrary and capricious in violation of the APA and the Fifth Amendment."

The Judge added that:

Because the 2023 REMS modification is inadequately supported, it will be REMANDED to the FDA for further proceedings consistent with this opinion following determination of the status of the constitutional claims. It is so ORDERED.

According to WTOP, Ballou did not give a timeline for a review of the restrictions.

Pro-abortion advocates are claiming victory, pointing to a separate lawsuit in Hawaii (Purcell v Kennedy), which also found the 2023 REMS "arbitrary and capricious."

But the Virginia court opinion also mentioned a lawsuit out of Washington (Washington v FDA), which found that the FDA's changes were "reasonable."

Why it Matters:

Since 2016, there has been no requirement that complications associated with the abortion drug mifepristone be reported. This has made it next to impossible to understand the dangers and risks of the drug.

However, an insurance database analysis from the Ethics and Public Policy Center found that adverse events from the abortion pill occur at a rate 22 times higher than that reported on the FDA's drug label. A previous study found that mifepristone is four times more dangerous than a first-trimester surgical abortion. As Live Action News previously reported:

Recent research from Ireland about the abortion pill showed 12% of women went to the ER for bleeding or infection. In addition, 16% suffered incomplete abortions.

This percentage corresponds with a recent U.S. insurance database analysis from the EPPC, showing a nearly 11% “serious adverse events” rate after taking the abortion pill.

In addition, abortionist Mitchell Creinin has said he can't say that the abortion pill is as 'safe as Tylenol' (as has been claimed) because there have been no  "long-term" studies on abortion pill use.

Mifepristone should be treated differently than other "medications," because its use as an abortion drug means its intention is not to heal but to end the lives of innocent preborn human beings.