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.

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.

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

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.”

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.

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.

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.

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.

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...

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.”

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.

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.

... 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.

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.

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.

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.

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.

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.

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

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.”

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.

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.

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.

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.

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...

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.”

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.

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.

... 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.

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.

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.

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.