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Court of Appeals hears oral arguments in Louisiana abortion pill lawsuit
Oral arguments before the Court of Appeals in the Fifth Circuit were heard today in the abortion pill case, State of Louisiana v. Food and Drug Administration (FDA), et al., which includes abortion pill manufacturers GenBioPro (GBP) and Danco Laboratories as Defendants.
The case challenges the FDA's 2023 REMS safety program which removed the in-person dispensing requirement on the drug mifepristone (200mg)/Mifeprex, allowing for mail-order and pharmacy distribution of the abortion pill.
Louisiana continues to appeal its abortion pill case against the FDA and the abortion pill's manufacturers before the Fifth Circuit.
The state argues that the FDA 2023 REMS abortion pill safeguard changes violate the Supreme Court's ruling in Dobbs v. Jackson, because the abortion pill by mail violates Louisiana's ability to make and enforce its own abortion laws.
Stateline explained:
Earlier this year, the 5th Circuit ruled in favor of Louisiana’s motion to temporarily reinstate an old rule that patients could only receive mifepristone in person. The Supreme Court blocked that ruling, allowing telehealth abortion to continue as the case progresses.
Whatever the appeals court rules this time, it will likely go back to the Supreme Court for a final ruling on Louisiana’s motion to reverse the policy until the case is decided on the merits.... The state is arguing in part that the 2023 FDA rule violated the 2022 Dobbs v. Jackson Women’s Health Organization decision by allowing for telehealth abortion and abortion by mail in states that banned abortion, like Louisiana.
The FDA has so far argued Louisiana doesn’t have standing to sue and that it needs more time to review the drug’s safety. Two mifepristone drugmakers have intervened on the FDA’s side.
The Plaintiffs — the State of Louisiana and Rosalie Markezich, a Louisiana woman who says her ex-boyfriend coerced her into taking abortion drugs — represented by the Alliance Defending Freedom (ADF), contended that the drug's 2023 REMS (safety regulations)...
Were arbitrary and capricious.
Violate the Comstock Act.
Cause Plaintiffs’ current and future injuries in fact.
Cause sovereign harm by facilitating illegal abortions in Louisiana.
Cause economic harm by directly increasing Louisiana’s Medicaid costs.
Louisiana's release announcing oral Wednesday's hearing stated in part:
In the case, Louisiana is asking the court to require the FDA restore the in-person dispensing requirement for the abortion drug mifepristone. As it stands currently, out-of-state pro-abortion doctors mail mifepristone to thousands of Louisiana residents for the express purpose of causing abortions that are blatantly unlawful...
... ADF attorneys also represent Rosalie Markezich, a Louisiana woman who, under immense pressure from her then-boyfriend and fearing for her safety, took abortion drugs that he ordered online from a doctor in California. Markezich did not want an abortion, but far from empowering her to make her own choice and preserve her autonomy, the FDA’s removal of the in-person dispensing requirement enabled her boyfriend to coerce her into taking the mail-order drugs—leading to her child’s death.
In 2023, the Biden FDA permanently removed the in-person dispensing requirement from its Risk Evaluation and Mitigation Strategy for 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.
In its appeal before the Fifth Circuit, Louisiana pointed out that the state would likely succeed in its claims, writing in part:
Just days ago, Acting Attorney General Todd Blanche testified before Congress that “we are not defending what Biden did, and will not”: The 2023 REMS is “wrong,” and Louisiana’s laws are “really what’s being violated here.”
Plaintiffs' appeal argued the following:
Louisiana has Article III standing: Louisiana’s economic injuries establish standing
Louisiana’s sovereign injuries confirm standing.
The 2023 REMS is likely unlawful.
The manufacturers’ threshold arguments are meritless.
The manufacturers cannot rehabilitate the FDA’s reliance on FAERS data.
The FDA’s arbitrary reliance on scientific literature is indisputable.
The 2023 REMS violates the Comstock Act.
The Plaintiffs' appeal addressed the FDA's and manufacturers' claims, writing in part:
First, FDA strangely spends significant time slaying a straw man— insisting that the district court’s decision to stay proceedings below was not an abuse of discretion.... But buried in FDA’s brief... ultimately is a concession that Plaintiffs “never” argued otherwise in their opening brief.
The reason Plaintiffs did not argue otherwise is that the district court’s existing stay of proceedings would cause no material harm if it were coupled with a § 705 stay of the 2023 REMS—hence Plaintiffs’ challenge on appeal to the district court’s denial of relief under § 705.2 They do not challenge the district court’s existing stay of proceedings.
The Court should thus ignore FDA’s efforts to transform this appeal into one FDA wishes Plaintiffs had filed.
"By expressly asking this Court to enter a § 705 stay, Plaintiffs necessarily are asking the Court to reverse the district court’s denial of such a stay," the footnotes read.
"FDA also claims that Plaintiffs are asking the merits panel to 'defy the Supreme Court' by staying the 2023 REMS.... That rhetoric is severely overblown," Louisiana wrote, adding:
As FDA admits... Plaintiffs have agreed that this Court should stay its own decision in Plaintiffs’ favor pending Supreme Court review, even though the Supreme Court’s stay decision is “not conclusive as to the merits” of this appeal... To be sure, Plaintiffs acknowledge the Supreme Court’s unshakeable interest in resolving issues surrounding mifepristone.
The Plaintiffs then added:
With that procedural underbrush cleared, the merits of this appeal are remarkably straightforward—confirmed, in significant part, by the Acting Attorney General’s agreement that the 2023 REMS’s removal of the in-person dispensing requirement is “wrong” and the U.S. Department of Justice’s refusal to “defend[] what Biden did.
Additional arguments from the Plaintiffs' appeal claimed that the FDA "concedes that Louisiana is suffering completely predictable economic... injuries from the 2023 REMS" and that the FDA's only concern, which is "unfounded," is that "ruling for Louisiana would purportedly allow any state to sue over any federal policy it dislikes."
Standing: Whether the judges focus heavily on whether Louisiana has demonstrated sufficient injury to challenge the FDA's nationwide rules.
FDA authority: How the court evaluates the agency's decision-making under the Administrative Procedure Act.
Mail-order access: Whether the court views the FDA's decision to permit mailed mifepristone as legally sustainable.
Scope of relief: Whether any eventual remedy would apply only to the challenged FDA rule or could have broader nationwide consequences.
Relationship to the FDA review: How the litigation may interact with the Trump Administration's ongoing regulatory review.
Mark Wiltz, Director of Government Affairs for Live Action, told Live Action News:
"Wednesday's Fifth Circuit argument is a major test of whether the federal government can continue allowing mifepristone to be prescribed remotely and distributed by mail while the Trump FDA simultaneously conducts its own review of the drug's regulatory status."
"The abortion pill lobby has had its way with the FDA for too long. The era of rubber-stamping abortion drugs needs to end," Wiltz added.
The mailing of abortion pills has been credited for the vast increase in abortions since the Dobbs Supreme Court decision.
“If Louisiana wins this case, we’re going to see for the first time what it looks like under an actual Dobbs regime, where pro-life states get to enforce their laws protecting the unborn,” Gabriella McIntyre, legal counsel of ADF told the Hays Post.
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.
September 2025: The State of Louisiana along with Rosalie Markezich filed a motion to intervene in an ongoing abortion pill lawsuit. Markezich alleged in her complaint that her boyfriend ordered abortion pills from a California provider and coerced her into taking the pills. Her baby died.
August 2025: Judge Judge Matthew Kacsmaryk denied the motions by Texas, Florida, and Louisiana and moved the venue to Missouri.
October 2025: Alliance Defending Freedom (ADF) refiled the lawsuit in State of Louisiana v. FDA (along with Rosalie Markezich) in the Western District of Louisiana, Lafayette Division.
December 9, 2025: A new lawsuit, State of Florida and the State of Texas v. FDA, was filed in the Northern District of Texas, Wichita Falls Division.
December 17, 2025: Louisiana filed for preliminary injunctive relief.
January 27, 2026: FDA filed a motion to stay the case.
February 2026: 21 states file in support of Louisiana, along with another brief from 60 lawmakers.
February 24, 2026: The case, State of Louisiana v. Food and Drug Administration (FDA), et al. was heard in federal court before U.S. District Judge David Joseph
April 2026: “A federal district court upholds Louisiana’s ability to challenge the FDA, also adding that it is likely to succeed on the merits of the case. However, the court also puts the case on hold while the FDA conducts a safety study on mifepristone. ADF and Louisiana appeal to the U.S. Court of Appeals for the 5th Circuit,” reported ADF.
May 2026: "The 5th Circuit ruled in Louisiana’s and Rosalie’s favor, putting a nationwide hold on the FDA’s regulation allowing mifepristone to be prescribed online and mailed. Drug manufacturers Danco Laboratories and GenBioPro sought emergency relief from that ruling at the U.S. Supreme Court. Sadly, the Court issued an order that allows high-risk abortion drugs to continue flowing into pro-life states while the state of Louisiana and ADF attorneys litigate the case back at the 5th Circuit.” reported ADF.
June 2026: A senior FDA official under the Trump administration confirmed that the promised safety review of mifepristone was moving forward, and could be completed within months, with some speculating it could happen between September and December of this year.
August 2026: A separate federal case brought by Florida and Texas has been paused while the FDA completes that review, with the current stay running until December 1, 2026, or completion of the FDA review, whichever comes first.
August 2026: An investigative report led by Senator Bill Cassidy has accused abortion pill manufacturers of being unaccountable, and of putting profit over safety by failing to decertify prescribers of the drug when they are out of compliance with the REMS, which increases abortion pill sales.
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Right to Life UK
·
Abortion Pill
Nancy Flanders
·
Abortion Pill
Bridget Sielicki
·
Abortion Pill
Nancy Flanders
·
Abortion Pill
Carole Novielli
·
Analysis
Nancy Flanders
·
Investigative
Carole Novielli
·Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·Abortion Pill·By Carole Novielli
Court of Appeals hears oral arguments in Louisiana abortion pill lawsuit
Oral arguments before the Court of Appeals in the Fifth Circuit were heard today in the abortion pill case, State of Louisiana v. Food and Drug Administration (FDA), et al., which includes abortion pill manufacturers GenBioPro (GBP) and Danco Laboratories as Defendants.
The case challenges the FDA's 2023 REMS safety program which removed the in-person dispensing requirement on the drug mifepristone (200mg)/Mifeprex, allowing for mail-order and pharmacy distribution of the abortion pill.
Louisiana continues to appeal its abortion pill case against the FDA and the abortion pill's manufacturers before the Fifth Circuit.
The state argues that the FDA 2023 REMS abortion pill safeguard changes violate the Supreme Court's ruling in Dobbs v. Jackson, because the abortion pill by mail violates Louisiana's ability to make and enforce its own abortion laws.
Stateline explained:
Earlier this year, the 5th Circuit ruled in favor of Louisiana’s motion to temporarily reinstate an old rule that patients could only receive mifepristone in person. The Supreme Court blocked that ruling, allowing telehealth abortion to continue as the case progresses.
Whatever the appeals court rules this time, it will likely go back to the Supreme Court for a final ruling on Louisiana’s motion to reverse the policy until the case is decided on the merits.... The state is arguing in part that the 2023 FDA rule violated the 2022 Dobbs v. Jackson Women’s Health Organization decision by allowing for telehealth abortion and abortion by mail in states that banned abortion, like Louisiana.
The FDA has so far argued Louisiana doesn’t have standing to sue and that it needs more time to review the drug’s safety. Two mifepristone drugmakers have intervened on the FDA’s side.
The Plaintiffs — the State of Louisiana and Rosalie Markezich, a Louisiana woman who says her ex-boyfriend coerced her into taking abortion drugs — represented by the Alliance Defending Freedom (ADF), contended that the drug's 2023 REMS (safety regulations)...
Were arbitrary and capricious.
Violate the Comstock Act.
Cause Plaintiffs’ current and future injuries in fact.
Cause sovereign harm by facilitating illegal abortions in Louisiana.
Cause economic harm by directly increasing Louisiana’s Medicaid costs.
Louisiana's release announcing oral Wednesday's hearing stated in part:
In the case, Louisiana is asking the court to require the FDA restore the in-person dispensing requirement for the abortion drug mifepristone. As it stands currently, out-of-state pro-abortion doctors mail mifepristone to thousands of Louisiana residents for the express purpose of causing abortions that are blatantly unlawful...
... ADF attorneys also represent Rosalie Markezich, a Louisiana woman who, under immense pressure from her then-boyfriend and fearing for her safety, took abortion drugs that he ordered online from a doctor in California. Markezich did not want an abortion, but far from empowering her to make her own choice and preserve her autonomy, the FDA’s removal of the in-person dispensing requirement enabled her boyfriend to coerce her into taking the mail-order drugs—leading to her child’s death.
In 2023, the Biden FDA permanently removed the in-person dispensing requirement from its Risk Evaluation and Mitigation Strategy for 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.
In its appeal before the Fifth Circuit, Louisiana pointed out that the state would likely succeed in its claims, writing in part:
Just days ago, Acting Attorney General Todd Blanche testified before Congress that “we are not defending what Biden did, and will not”: The 2023 REMS is “wrong,” and Louisiana’s laws are “really what’s being violated here.”
Plaintiffs' appeal argued the following:
Louisiana has Article III standing: Louisiana’s economic injuries establish standing
Louisiana’s sovereign injuries confirm standing.
The 2023 REMS is likely unlawful.
The manufacturers’ threshold arguments are meritless.
The manufacturers cannot rehabilitate the FDA’s reliance on FAERS data.
The FDA’s arbitrary reliance on scientific literature is indisputable.
The 2023 REMS violates the Comstock Act.
The Plaintiffs' appeal addressed the FDA's and manufacturers' claims, writing in part:
First, FDA strangely spends significant time slaying a straw man— insisting that the district court’s decision to stay proceedings below was not an abuse of discretion.... But buried in FDA’s brief... ultimately is a concession that Plaintiffs “never” argued otherwise in their opening brief.
The reason Plaintiffs did not argue otherwise is that the district court’s existing stay of proceedings would cause no material harm if it were coupled with a § 705 stay of the 2023 REMS—hence Plaintiffs’ challenge on appeal to the district court’s denial of relief under § 705.2 They do not challenge the district court’s existing stay of proceedings.
The Court should thus ignore FDA’s efforts to transform this appeal into one FDA wishes Plaintiffs had filed.
"By expressly asking this Court to enter a § 705 stay, Plaintiffs necessarily are asking the Court to reverse the district court’s denial of such a stay," the footnotes read.
"FDA also claims that Plaintiffs are asking the merits panel to 'defy the Supreme Court' by staying the 2023 REMS.... That rhetoric is severely overblown," Louisiana wrote, adding:
As FDA admits... Plaintiffs have agreed that this Court should stay its own decision in Plaintiffs’ favor pending Supreme Court review, even though the Supreme Court’s stay decision is “not conclusive as to the merits” of this appeal... To be sure, Plaintiffs acknowledge the Supreme Court’s unshakeable interest in resolving issues surrounding mifepristone.
The Plaintiffs then added:
With that procedural underbrush cleared, the merits of this appeal are remarkably straightforward—confirmed, in significant part, by the Acting Attorney General’s agreement that the 2023 REMS’s removal of the in-person dispensing requirement is “wrong” and the U.S. Department of Justice’s refusal to “defend[] what Biden did.
Additional arguments from the Plaintiffs' appeal claimed that the FDA "concedes that Louisiana is suffering completely predictable economic... injuries from the 2023 REMS" and that the FDA's only concern, which is "unfounded," is that "ruling for Louisiana would purportedly allow any state to sue over any federal policy it dislikes."
Standing: Whether the judges focus heavily on whether Louisiana has demonstrated sufficient injury to challenge the FDA's nationwide rules.
FDA authority: How the court evaluates the agency's decision-making under the Administrative Procedure Act.
Mail-order access: Whether the court views the FDA's decision to permit mailed mifepristone as legally sustainable.
Scope of relief: Whether any eventual remedy would apply only to the challenged FDA rule or could have broader nationwide consequences.
Relationship to the FDA review: How the litigation may interact with the Trump Administration's ongoing regulatory review.
Mark Wiltz, Director of Government Affairs for Live Action, told Live Action News:
"Wednesday's Fifth Circuit argument is a major test of whether the federal government can continue allowing mifepristone to be prescribed remotely and distributed by mail while the Trump FDA simultaneously conducts its own review of the drug's regulatory status."
"The abortion pill lobby has had its way with the FDA for too long. The era of rubber-stamping abortion drugs needs to end," Wiltz added.
The mailing of abortion pills has been credited for the vast increase in abortions since the Dobbs Supreme Court decision.
“If Louisiana wins this case, we’re going to see for the first time what it looks like under an actual Dobbs regime, where pro-life states get to enforce their laws protecting the unborn,” Gabriella McIntyre, legal counsel of ADF told the Hays Post.
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.
September 2025: The State of Louisiana along with Rosalie Markezich filed a motion to intervene in an ongoing abortion pill lawsuit. Markezich alleged in her complaint that her boyfriend ordered abortion pills from a California provider and coerced her into taking the pills. Her baby died.
August 2025: Judge Judge Matthew Kacsmaryk denied the motions by Texas, Florida, and Louisiana and moved the venue to Missouri.
October 2025: Alliance Defending Freedom (ADF) refiled the lawsuit in State of Louisiana v. FDA (along with Rosalie Markezich) in the Western District of Louisiana, Lafayette Division.
December 9, 2025: A new lawsuit, State of Florida and the State of Texas v. FDA, was filed in the Northern District of Texas, Wichita Falls Division.
December 17, 2025: Louisiana filed for preliminary injunctive relief.
January 27, 2026: FDA filed a motion to stay the case.
February 2026: 21 states file in support of Louisiana, along with another brief from 60 lawmakers.
February 24, 2026: The case, State of Louisiana v. Food and Drug Administration (FDA), et al. was heard in federal court before U.S. District Judge David Joseph
April 2026: “A federal district court upholds Louisiana’s ability to challenge the FDA, also adding that it is likely to succeed on the merits of the case. However, the court also puts the case on hold while the FDA conducts a safety study on mifepristone. ADF and Louisiana appeal to the U.S. Court of Appeals for the 5th Circuit,” reported ADF.
May 2026: "The 5th Circuit ruled in Louisiana’s and Rosalie’s favor, putting a nationwide hold on the FDA’s regulation allowing mifepristone to be prescribed online and mailed. Drug manufacturers Danco Laboratories and GenBioPro sought emergency relief from that ruling at the U.S. Supreme Court. Sadly, the Court issued an order that allows high-risk abortion drugs to continue flowing into pro-life states while the state of Louisiana and ADF attorneys litigate the case back at the 5th Circuit.” reported ADF.
June 2026: A senior FDA official under the Trump administration confirmed that the promised safety review of mifepristone was moving forward, and could be completed within months, with some speculating it could happen between September and December of this year.
August 2026: A separate federal case brought by Florida and Texas has been paused while the FDA completes that review, with the current stay running until December 1, 2026, or completion of the FDA review, whichever comes first.
August 2026: An investigative report led by Senator Bill Cassidy has accused abortion pill manufacturers of being unaccountable, and of putting profit over safety by failing to decertify prescribers of the drug when they are out of compliance with the REMS, which increases abortion pill sales.
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Right to Life UK
·Abortion Pill
Nancy Flanders
·Abortion Pill
Bridget Sielicki
·Abortion Pill
Nancy Flanders
·Abortion Pill
Carole Novielli
·Analysis
Nancy Flanders
·Investigative
Carole Novielli
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·WATCH: Our client, Rosalie Markezich, is co-plaintiff with @AGLizMurrill in a lawsuit against the FDA to ban mail-order abortion. She told her story at @HawleyMO's press conference.
NEW LAWSUIT: We’ve sued the FDA over its illegal, reckless, and politically-motivated approval of chemical abortion drugs. ADF attorney Erica Steinmiller-Perdomo explains. ⬇️
With Sen. Cassidy’s abortion pill regulation report now released and the U.S. Fifth Circuit hearing Louisiana’s case for stronger abortion drug safety regulations, here’s what AAPLOG’s undercover investigation found that abortion advocates aren’t telling you 👇 • Abortion drugs Show more
7. Conclusion: mail-order abortion is the “Wild West.” As drug companies look to their profits and the FDA looks the other way, no one is looking out for women’s health. This should end. The report recommends a first step: bring back the in-person dispensing requirement. ⬇️ Show more
