Court pauses mail-order abortion pill dispensing due to Louisiana lawsuit

UPDATE, 5/4/26: Upon request of abortion pill manufacturer Danco, the U.S. Supreme Court has granted a temporary administrative stay on the Fifth Circuit's decision, allowing mail-order abortion pill dispensing to be restored. The stay will end on May 11, 2026.

5/1/26: A U.S. Court of Appeals for the Fifth Circuit ruled in favor of the State of Louisiana's request to 'stay' the FDA's 2023 safety rules (REMS) for the abortion pill, essentially pausing mail-order dispensing of the drug while the Court considers Louisiana’s appeal from the district court’s denial of preliminary relief.

Alliance Defending Freedom (ADF) — which represented co-Plaintiffs the State of Louisiana and Rosalie Markezich (a woman coerced to abort) in the lawsuit — applauded the decision, claiming the "ruling prevents pro-abortion activists and doctors from mailing streams of high-risk abortion drugs into states that protect the lives of unborn babies."

Key Takeaways:

• The Fifth Circuit Court of Appeals ruled that Louisiana has a likelihood of success in its lawsuit against the FDA's changes to abortion pill safety protocols, which were made without solid data and without a reliable way for any adverse events other than death to be reported.

• The Court ruled that Louisiana had standing to sue, suffered sovereign injury, and that the FDA's abortion pill REMS changes undermined Louisiana law, causing "irreparable harm" that is ongoing.

The Details:

ADF's press release states:

In 2023, the Biden FDA permanently removed the in-person dispensing requirement from its Risk Evaluation and Mitigation Strategy for the abortion drug mifepristone. This action intentionally enabled out-of-state pro-abortion activists and doctors to blanket states like Louisiana, which has chosen to protect unborn children, with mail-order abortion drugs, thus nullifying state laws and putting unborn babies and women at serious risk.

'Balance of equities and public interest'

The memo opinion by Circuit Judges Leslie Southwick, Stuart Kyle Duncan, and Kurt Damian Engelhardt, stated that Louisiana's federal court challenge under the Administrative Procedure Act in 2025 argued:

• "FDA’s justifications for remotely dispensing mifepristone were based on flawed or nonexistent data."

• "The new regulation had resulted in numerous illegal abortions in Louisiana and in Louisiana paying thousands in Medicaid bills for women harmed by mifepristone."

The Court noted that the FDA: "conceded it had failed to adequately study whether remotely prescribing mifepristone is safe" but "resisted staying the regulation, arguing it was in the midst of a comprehensive review of mifepristone protocols."

Yet the FDA couldn't offer a date for the review's completion, and "admitted it was still collecting data.

The Court continued:

The district court agreed that Louisiana was likely to win its challenge to the mifepristone regulation and was suffering irreparable harm from it. Nonetheless, the court declined to stay the regulation based on its balancing of the equities and the public interest. Louisiana appealed to our court and sought a stay pending appeal under 5 U.S.C. § 705.

We grant the stay.

Notably, the ruling stated:

In sum, we conclude that the balance of equities and public interest weigh in Louisiana’s favor.

The Court found that:

• Louisiana was not required to administratively exhaust its claims before bringing this suit.

• Louisiana not only had standing but that the 2023 REMS caused injury to the state and undermined Louisiana's ability to enforce their laws.

• "Louisiana has strongly shown a likelihood of winning its APA challenge to the 2023 REMS."

• Louisiana has suffered 'irreparable harm.'

'Progressively lowering' guardrails

From the Court's ruling (emphases added):

When FDA approved mifepristone in 2000, the REMS allowed only doctors to prescribe it after “three in-person visits” and directed they report serious adverse events... Since then, the guardrails have been progressively lowered.

In 2016, FDA announced that nurse practitioners could prescribe mifepristone after only one in-person doctor visit and that doctors needed to report only fatalities...

In 2021, FDA stopped enforcement of the one-visit requirement, thus allowing mifepristone to be dispensed “through the mail . . . or through a mail-order pharmacy” (the “2021 Non-Enforcement Decision”).

That “removal of the in-person dispensing requirement” was formalized in 2023...

In September 2025, FDA began a comprehensive review of mifepristone, including the 2023 REMS. When announcing the review, FDA conceded the “lack of adequate consideration underlying the prior REMS approvals.”

The Court noted that the FDA is reportedly "still collecting data" and that "the district court allowed mifepristone manufacturers Danco and GenBioPro... to intervene as defendants," yet declined to pause mail-order abortions, "despite finding Louisiana had standing, was likely to succeed on the merits, and was suffering irreparable harm" (emphasis added).

1st Trimester Abortion | The Abortion Pill | What Is Abortion?

Highlights:

The Court noted the following in its decision...

1. State not required to exhaust claims

Danco argues Louisiana failed to administratively exhaust its claims... Our court previously rejected this argument in Alliance I and II...

Accordingly, we reject the argument that Louisiana was required to administratively exhaust its claims before bringing this suit.

2. Louisiana has standing to sue

On appeal, FDA and Danco dispute the district court’s ruling that Louisiana has standing. Specifically, they contend that by removing mifepristone’s in-person dispensing requirement, the 2023 REMS caused no injury either to Louisiana’s sovereignty or its treasury.

We disagree.

3. Louisiana suffered sovereign injury

First, sovereign injury...

By ending the in-person dispensing requirement, FDA opened the door for mifepristone to be remotely prescribed to Louisiana women.

The record shows that the policy now facilitates nearly 1,000 illegal abortions in Louisiana per month.

4. 2023 REMS undermines Louisiana's law

FDA and Danco counter that the 2023 REMS only makes it “more difficult to police” violations of Louisiana law.

Not so.

The policy does not merely “increase[] crime or disorder, or impose[] indirect compliance costs for state law enforcement.” ...

Rather, the 2023 REMS sanctions and facilitates conduct with the express purpose of undermining Louisiana’s legal restrictions on abortion.

The regulation creates an effective way for an out-of-state prescriber to place the drug in the hands of Louisianans in defiance of Louisiana law.

"In sum, the agency’s 2023 REMS causes 'federal interference with the enforcement of [Louisiana] law,' which gives Louisiana standing to challenge it," the order read.

5. 2023 REMS caused financial harm

Louisiana identifies $92,000 it paid in Medicaid costs from two women who needed emergency care in 2025 from complications caused by out-of-state mifepristone. Such costs will almost certainly continue because nearly 1,000 women monthly—many of whom are on Medicaid—have mifepristone-induced abortions in Louisiana...

On the claim that safety erosions caused higher Medicaid costs, the Court agreed:

Here, Louisiana showed that they do.

Unlike the doctors in Alliance III, Louisiana provided hard evidence linking thousands of dollars in Medicaid costs to care stemming from out-of-state mifepristone.

As the district court correctly held, that “alone [is] sufficient to establish Louisiana’s standing.”

"In sum, on either theory Louisiana has shown it has standing to challenge the 2023 REMS," the ruling read.

6. Louisiana lawsuit likely to succeed

Louisiana must make a strong showing that the 2023 REMS was not “reasonable” or “reasonably explained.”

...This factor plainly favors Louisiana and FDA does not contest it...

Based on the same defects, our court has previously concluded that FDA’s actions here were likely unlawful...

That reasoning squarely applies to the 2023 REMS and we briefly summarize it.

The Court noted the following:

• When the FDA "relax[ed] mifepristone's in-person dispensing requirement," it "gave 'dispositive weight' to the lack of adverse-event data in... FAERS [FDA Adverse Event Reporting System]." The problem was that the "FDA had previously eliminated the requirement to report mifepristone’s adverse events to FAERS."

• The Court called it "unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.”

• The FDA “relied on various literature relating to remote prescription of mifepristone—despite FDA’s admission that the literature did not affirmatively support its position," even admitting that "the literature was 'not adequate on [its] own to establish the safety of the model of dispensing mifepristone by mail.'"

The Court stated bluntly, "This is a textbook example of arbitrary and capricious agency action."

"Accordingly, like the district court, we conclude Louisiana has strongly shown a likelihood of winning its APA challenge to the 2023 REMS," the ruling added (emphases added).

7. Louisiana suffered 'irreparable harm'

We agree with the district court that Louisiana has shown it is suffering irreparable harm, largely for the same reasons Louisiana has shown injury for standing purposes.

The Court said this harm was caused by the 2023 REMS by "undermining" Louisiana's pro-life law, and "by causing it to spend Medicaid funds on emergency care for women harmed by mifepristone. Both injuries are irreparable." It added:

Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions and undermines its policy that “every unborn child is human being from the moment of conception and is, therefore, a legal person.” ...

Once lost, that sovereign prerogative of protecting unborn life cannot be regained by legal remedy. And because FDA “is entitled to sovereign immunity,” ... Louisiana’s financial harms are also irremediable.

The Court added:

... Like the district court, we conclude that Louisiana has shown that it is irreparably harmed without a stay.

Louisiana argues the district court erred by finding its irreparable harms are outweighed by FDA’s interest in continuing its review and Danco’s financial interests in selling mifepristone.

We agree.

The Legal Context:

Pointing to previous decisions, the Court wrote (emphasis added)

We have now three times found that the agency’s progressive relaxation of mifepristone’s guardrails likely lacked a basis in data and scientific literature... The public interest is not served by perpetuating a medical practice whose safety the agency admits was inadequately studied. Indeed, the public interest demands the opposite.

The Court also addressed abortion pill manufacturer Danco:

While we acknowledge a stay would impose costs on Danco... the company exaggerates by predicting a stay would destroy any “valid legal framework for distributing” the drug.

To the contrary, a stay would only pause a method of prescribing mifepristone that began five years ago and was formally approved only three years ago...

And, in any event, Danco’s potential financial losses pale beside Louisiana’s sovereign interest in its laws protecting the unborn and the public’s interest in not exposing women to unsafe medical procedures.

The ruling pushed back on arguments that the Court was “not a forum for resolving moral or policy disagreements,” nor for adjudicating “scientific and medical judgments committed by Congress to an agency with specialized knowledge.” The Court stated:

All quite true. This case, however, does not ask courts to resolve such matters...

Granting a stay would do nothing to prevent FDA from completing its review of mifepristone’s safety protocols...

And here FDA cannot even say when its review will conclude—perhaps over a year from now because it has not finished collecting data.

The Bottom Line:

Lila Rose, Founder and president of Live Action called the decision a "major step toward justice" but urged the FDA to immediately pull the drug altogether.

"This must be the turning point," Rose stated. "We are calling on Health and Human Services Secretary Robert F. Kennedy Jr. and President Donald Trump to act immediately to take this dangerous drug off the market once and for all with a full and permanent ban."