Abortion Pill
'Without guardrails': Abortion pill manufacturer refuses to disclose revenue
Carole Novielli
·Spotlight Articles
Abortion Pill·By Carole Novielli
Judge pauses Louisiana abortion pill lawsuit pending FDA 'safety review'
UPDATE, 4/20/26: On April 17, Louisiana AG Liz Murrill filed a "motion for stay or injunction pending appeal" with the Fifth Circuit Court of Appeals. A press release notes, "I have asked the Fifth Circuit to stay the Biden Administration’s unlawful removal of the in-person dispensing requirement for mifepristone,” said Attorney General Murrill. “As the district court concluded, Louisiana is likely to win this case and is suffering irreparable harm. Louisiana will always stand for life.”
4/10/26: A U.S. District Court sided with the Food and Drug Administration (FDA) by issuing a "motion to stay" an abortion pill lawsuit filed by the State of Louisiana while the FDA completes a safety review of the drug, but said the state is likely to succeed in its lawsuit.
The Court also denied "without prejudice" a motion to dismiss the lawsuit filed by the drug's manufacturers, Danco and GenBioPro, while the FDA conducts a safety review of the abortion pill.
The ruling surprisingly affirmed that the State of Louisiana not only has standing to sue, but agreed that — in the words of Louisiana's Solicitor General Ben Aguiñaga — states like Louisiana are "suffering irreputable sovereign harm everyday that this 2023 REMS... remains in effect."
U.S. District Judge David C. Joseph ruled in favor of the FDA, allowing the agency to complete its review of mifepristone and issuing a "motion to stay" Louisiana's abortion pill lawsuit challenging the FDA's 2023 REMS.
The judge says Louisiana has standing to sue, and is also "likely to succeed" in its lawsuit, as "The Fifth Circuit has twice indicated... that FDA was likely arbitrary and capricious under the APA in removing mifepristone’s in-person dispensing requirement."
The judge agreed that the state of Louisiana has suffered harm due to the FDA's decision to allow the drug to be distributed without an in-person visit.
The judge denied the abortion pill manufacturers' motion to dismiss Louisiana's lawsuit.
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. The Obama FDA weakened the REMS, even removing the requirement to report the drug's adverse events other than deaths.
2023: Despite a prohibition under the federal Comstock Act, Biden's FDA weakened the REMS again to remove the in-person dispensing requirement and allow for mail order and pharmacy dispensing of the drug.
The decision to halt the reporting of non-fatal adverse events (complications) of the abortion pill in 2016 may have led to faulty conclusions that the drug is safe.
2022: The Alliance for Hippocratic Medicine (AHM) challenged the FDA's approval and erosions of REMS safety regulations.
2024: The U.S. Supreme Court ruled AHM's plaintiff doctors did not have standing to sue, and AHM eventually dropped their challenge.
October 6, 2025: State of Louisiana v. Food and Drug Administration (along with Rosalie Markezich) was refiled in the Western District of Louisiana, Lafayette Division. Louisiana later filed for preliminary injunctive relief.
January 27, 2026: Trump's FDA petitioned the Court to "stay all proceedings" until the FDA completes its review, which the FDA claimed could be completed in less than a year.
February 13, 2026: 21 states file in support of Louisiana, and 60 lawmakers filed an amicus brief in support as well.
February 17, 2026: Louisiana responds, accusing the FDA and abortion pill manufacturers of "try[ing] to scuttle the case on standing grounds."
February 24, 2026: The court heard oral arguments on pending motions and "granted the Motions to Intervene filed by mifepristone manufacturers Danco and GenBioPro."
April 7, 2026: A stay in the lawsuit was approved until the FDA safety review is completed.
April 8, 2026: Louisiana appealed the 'stay' ruling.
The April 7, 2026 opinion, written by U.S. District Judge David C. Joseph, claimed to prioritize "public interest" by allowing the FDA time to complete a "safety review" of the drug.
Joseph's opinion stated:
FDA does not defend its decision-making on the merits but instead acknowledges deficits and requests a stay to complete a fulsome review of the merits of Plaintiffs’ claims – a review that was announced before this lawsuit was filed and has already been initiated... FDA also has the authority to take interim actions to ensure drug safety if new information is discovered during the pendency of its review.
"In staying a case pursuant to this authority, the Court should 'balance between the harm of moving forward [with the litigation] and the harm of holding back,'" he added.
"No doubt Louisiana has a great interest in this issue... Dobbs returned the issue of abortion to the people of the States and their elected representatives, including regulation of abortion methods, procedures, and the use of related drugs," Joseph's ruling stated.
Plaintiffs claimed injuries include:
"harm to state sovereignty"
"increased Medicaid expenditures, including over $92,000 in 2025 emergency room and hospitalization costs from two mifepristone-induced abortions and projections of hundreds of thousands of dollars in similar costs"
"public-health harms, including statistically-certain emergency room visits and risks of serious and sometimes fatal infections and bleeding"
However, the judge wrote, "The 2023 REMS clearly facilitates easier access to mifepristone for Louisiana residents," reiterating that Louisiana has a "duty to enforce its own laws...."
The court pointed to evidence that:
"[t]he 2023 REMS was approved without adequate consideration, at least in part, as an effort to circumvent anti-abortion states’ ability to regulate abortion."
"[t]he consequences of this action were predictable – out-of-state providers and related entities would expand access to mifepristone in ways designed to reach into jurisdictions like Louisiana. These actions cause concrete and ongoing injury to Louisiana..."
The judge's ruling also affirmed that Louisiana has standing to sue and will likely prevail in its claims:
The Fifth Circuit has twice indicated... that FDA was likely arbitrary and capricious under the APA in removing mifepristone’s in-person dispensing requirement.
Louisiana argued it has standing because:
"the 2023 REMS causes sovereign harm by facilitating abortions that violate numerous Louisiana state laws"
"it continues to suffer ongoing financial injury resulting from the 2023 REMS and has already paid hundreds of thousands of dollars through Louisiana Medicaid for emergency room medical care stemming from mifepristone use by residents."
The judge wrote:
Here, Louisiana alleges that an unlawful use of federal regulatory power by an administrative agency directly undermines the enforcement of its own laws and forces it to incur additional costs.
The judge noted the dilemma at play:
... if ... FDA acted lawfully in its removal of the in-person dispensing requirement for mifepristone, then Louisiana would have no judicial recourse...
... if FDA did not act lawfully...but rather exceeded or abused the power vested in it by Congress as Plaintiffs contend, then Louisiana clearly has an interest in vindicating its sovereign prerogative under basic principles of federalism.
Citing "shield laws" enacted in pro-abortion states enabling abortion pills to flood across borders of pro-life states like Louisiana, the court document stated:
Plaintiffs further estimate that, on average, about 1,000 mifepristone-induced abortions are occurring per month in Louisiana. And, according to Plaintiffs’ expert, many of these women obtaining abortions are likely to be on Medicaid.
The judge's opinion states:
Plaintiffs have supplied evidence... identifying more than $92,000 in Medicaid costs incurred for emergency room care and hospitalizations required because of two mifepristone-induced abortions in 2025 in which the drugs were received from out-of-state prescribers.
...These two incidents alone are sufficient to establish Louisiana’s standing, but it is likely that many more Medicaid patients have required similar care due to complications from mifepristone.
Claiming "Louisiana’s harm is more than zero" the judge cited the following as sufficient for standing:
"even if the 2023 REMS is not the 'sole cause' of Louisiana’s sovereign harms, it has surely 'exacerbated' them"
“[m]onetary costs are of course an injury” for standing purposes.
“even one dollar’s worth of harm is traditionally enough to” confer standing...
A state’s increased medical costs, such as increased Medicaid costs due to a federal agency action, can constitute a “pocket-book injury” sufficient to satisfy the injury-in-fact requirement of standing.
"For all of these reasons, Louisiana has established injury that is traceable to FDA’s actions and redressable, at least in part, by the relief requested herein. Louisiana therefore has standing..." the judge wrote, adding, the "Court concludes that Plaintiffs are likely to succeed on the merits of their 2023 REMS challenge" (emphasis added).
"After a review of the record and the complex regulatory and judicial history of this subject matter, the Court declines to grant the Plaintiffs... relief at this time," the court document stated, adding:
The record shows that FDA is currently in the process of “conducting its own review of the evidence” with respect to the current...“REMS”, “to determine whether modifications are necessary.”
And “courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”
The judge claimed the completion of the FDA's review, not “government by lawsuit,” is in the "public interest."
He outlined potential outcomes:
On the one hand, a proper science-driven evaluation may lead FDA to conclude that the in-person dispensing requirement is necessary to comply with FDA’s mandate to ensure that mifepristone is “safe and effective” for use, and Plaintiffs offer substantial evidence supporting that possibility.
On the other hand, FDA may determine, after a thorough and scientifically-driven process, that such a requirement is not required.
Citing "prudence in issuing injunctive relief" and "five other lawsuits in federal courts around the nation addressing issues similar to those before the Court," the judge claimed:
This Court is ill-equipped to make this determination... ultimately it is FDA, not this Court, that possesses the expertise to evaluate scientific evidence and make public health judgments...
FDA’s review should be conducted and completed free from judicial interference.
The judge ordered the matter "STAYED pending completion of FDA’s ongoing review" but would only afford FDA a "time limited period of deference to complete its review," writing that the "stay granted to FDA will not remain open-ended."
He ordered:
60 Days: FDA must produce entirety of the administrative record to Plaintiffs’ counsel.
6 Months: FDA must file a report providing the Court with the status of its review.
14 Days: After FDA completes its REMS review, FDA shall file a brief advising the Court of any agency action.
"Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change," the judge wrote.
In response, the State of Louisiana has appealed the 'stay' to the United States Court of Appeals for the Fifth Circuit.
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!
Abortion Pill·By Carole Novielli
Judge pauses Louisiana abortion pill lawsuit pending FDA 'safety review'
UPDATE, 4/20/26: On April 17, Louisiana AG Liz Murrill filed a "motion for stay or injunction pending appeal" with the Fifth Circuit Court of Appeals. A press release notes, "I have asked the Fifth Circuit to stay the Biden Administration’s unlawful removal of the in-person dispensing requirement for mifepristone,” said Attorney General Murrill. “As the district court concluded, Louisiana is likely to win this case and is suffering irreparable harm. Louisiana will always stand for life.”
4/10/26: A U.S. District Court sided with the Food and Drug Administration (FDA) by issuing a "motion to stay" an abortion pill lawsuit filed by the State of Louisiana while the FDA completes a safety review of the drug, but said the state is likely to succeed in its lawsuit.
The Court also denied "without prejudice" a motion to dismiss the lawsuit filed by the drug's manufacturers, Danco and GenBioPro, while the FDA conducts a safety review of the abortion pill.
The ruling surprisingly affirmed that the State of Louisiana not only has standing to sue, but agreed that — in the words of Louisiana's Solicitor General Ben Aguiñaga — states like Louisiana are "suffering irreputable sovereign harm everyday that this 2023 REMS... remains in effect."
U.S. District Judge David C. Joseph ruled in favor of the FDA, allowing the agency to complete its review of mifepristone and issuing a "motion to stay" Louisiana's abortion pill lawsuit challenging the FDA's 2023 REMS.
The judge says Louisiana has standing to sue, and is also "likely to succeed" in its lawsuit, as "The Fifth Circuit has twice indicated... that FDA was likely arbitrary and capricious under the APA in removing mifepristone’s in-person dispensing requirement."
The judge agreed that the state of Louisiana has suffered harm due to the FDA's decision to allow the drug to be distributed without an in-person visit.
The judge denied the abortion pill manufacturers' motion to dismiss Louisiana's lawsuit.
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. The Obama FDA weakened the REMS, even removing the requirement to report the drug's adverse events other than deaths.
2023: Despite a prohibition under the federal Comstock Act, Biden's FDA weakened the REMS again to remove the in-person dispensing requirement and allow for mail order and pharmacy dispensing of the drug.
The decision to halt the reporting of non-fatal adverse events (complications) of the abortion pill in 2016 may have led to faulty conclusions that the drug is safe.
2022: The Alliance for Hippocratic Medicine (AHM) challenged the FDA's approval and erosions of REMS safety regulations.
2024: The U.S. Supreme Court ruled AHM's plaintiff doctors did not have standing to sue, and AHM eventually dropped their challenge.
October 6, 2025: State of Louisiana v. Food and Drug Administration (along with Rosalie Markezich) was refiled in the Western District of Louisiana, Lafayette Division. Louisiana later filed for preliminary injunctive relief.
January 27, 2026: Trump's FDA petitioned the Court to "stay all proceedings" until the FDA completes its review, which the FDA claimed could be completed in less than a year.
February 13, 2026: 21 states file in support of Louisiana, and 60 lawmakers filed an amicus brief in support as well.
February 17, 2026: Louisiana responds, accusing the FDA and abortion pill manufacturers of "try[ing] to scuttle the case on standing grounds."
February 24, 2026: The court heard oral arguments on pending motions and "granted the Motions to Intervene filed by mifepristone manufacturers Danco and GenBioPro."
April 7, 2026: A stay in the lawsuit was approved until the FDA safety review is completed.
April 8, 2026: Louisiana appealed the 'stay' ruling.
The April 7, 2026 opinion, written by U.S. District Judge David C. Joseph, claimed to prioritize "public interest" by allowing the FDA time to complete a "safety review" of the drug.
Joseph's opinion stated:
FDA does not defend its decision-making on the merits but instead acknowledges deficits and requests a stay to complete a fulsome review of the merits of Plaintiffs’ claims – a review that was announced before this lawsuit was filed and has already been initiated... FDA also has the authority to take interim actions to ensure drug safety if new information is discovered during the pendency of its review.
"In staying a case pursuant to this authority, the Court should 'balance between the harm of moving forward [with the litigation] and the harm of holding back,'" he added.
"No doubt Louisiana has a great interest in this issue... Dobbs returned the issue of abortion to the people of the States and their elected representatives, including regulation of abortion methods, procedures, and the use of related drugs," Joseph's ruling stated.
Plaintiffs claimed injuries include:
"harm to state sovereignty"
"increased Medicaid expenditures, including over $92,000 in 2025 emergency room and hospitalization costs from two mifepristone-induced abortions and projections of hundreds of thousands of dollars in similar costs"
"public-health harms, including statistically-certain emergency room visits and risks of serious and sometimes fatal infections and bleeding"
However, the judge wrote, "The 2023 REMS clearly facilitates easier access to mifepristone for Louisiana residents," reiterating that Louisiana has a "duty to enforce its own laws...."
The court pointed to evidence that:
"[t]he 2023 REMS was approved without adequate consideration, at least in part, as an effort to circumvent anti-abortion states’ ability to regulate abortion."
"[t]he consequences of this action were predictable – out-of-state providers and related entities would expand access to mifepristone in ways designed to reach into jurisdictions like Louisiana. These actions cause concrete and ongoing injury to Louisiana..."
The judge's ruling also affirmed that Louisiana has standing to sue and will likely prevail in its claims:
The Fifth Circuit has twice indicated... that FDA was likely arbitrary and capricious under the APA in removing mifepristone’s in-person dispensing requirement.
Louisiana argued it has standing because:
"the 2023 REMS causes sovereign harm by facilitating abortions that violate numerous Louisiana state laws"
"it continues to suffer ongoing financial injury resulting from the 2023 REMS and has already paid hundreds of thousands of dollars through Louisiana Medicaid for emergency room medical care stemming from mifepristone use by residents."
The judge wrote:
Here, Louisiana alleges that an unlawful use of federal regulatory power by an administrative agency directly undermines the enforcement of its own laws and forces it to incur additional costs.
The judge noted the dilemma at play:
... if ... FDA acted lawfully in its removal of the in-person dispensing requirement for mifepristone, then Louisiana would have no judicial recourse...
... if FDA did not act lawfully...but rather exceeded or abused the power vested in it by Congress as Plaintiffs contend, then Louisiana clearly has an interest in vindicating its sovereign prerogative under basic principles of federalism.
Citing "shield laws" enacted in pro-abortion states enabling abortion pills to flood across borders of pro-life states like Louisiana, the court document stated:
Plaintiffs further estimate that, on average, about 1,000 mifepristone-induced abortions are occurring per month in Louisiana. And, according to Plaintiffs’ expert, many of these women obtaining abortions are likely to be on Medicaid.
The judge's opinion states:
Plaintiffs have supplied evidence... identifying more than $92,000 in Medicaid costs incurred for emergency room care and hospitalizations required because of two mifepristone-induced abortions in 2025 in which the drugs were received from out-of-state prescribers.
...These two incidents alone are sufficient to establish Louisiana’s standing, but it is likely that many more Medicaid patients have required similar care due to complications from mifepristone.
Claiming "Louisiana’s harm is more than zero" the judge cited the following as sufficient for standing:
"even if the 2023 REMS is not the 'sole cause' of Louisiana’s sovereign harms, it has surely 'exacerbated' them"
“[m]onetary costs are of course an injury” for standing purposes.
“even one dollar’s worth of harm is traditionally enough to” confer standing...
A state’s increased medical costs, such as increased Medicaid costs due to a federal agency action, can constitute a “pocket-book injury” sufficient to satisfy the injury-in-fact requirement of standing.
"For all of these reasons, Louisiana has established injury that is traceable to FDA’s actions and redressable, at least in part, by the relief requested herein. Louisiana therefore has standing..." the judge wrote, adding, the "Court concludes that Plaintiffs are likely to succeed on the merits of their 2023 REMS challenge" (emphasis added).
"After a review of the record and the complex regulatory and judicial history of this subject matter, the Court declines to grant the Plaintiffs... relief at this time," the court document stated, adding:
The record shows that FDA is currently in the process of “conducting its own review of the evidence” with respect to the current...“REMS”, “to determine whether modifications are necessary.”
And “courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”
The judge claimed the completion of the FDA's review, not “government by lawsuit,” is in the "public interest."
He outlined potential outcomes:
On the one hand, a proper science-driven evaluation may lead FDA to conclude that the in-person dispensing requirement is necessary to comply with FDA’s mandate to ensure that mifepristone is “safe and effective” for use, and Plaintiffs offer substantial evidence supporting that possibility.
On the other hand, FDA may determine, after a thorough and scientifically-driven process, that such a requirement is not required.
Citing "prudence in issuing injunctive relief" and "five other lawsuits in federal courts around the nation addressing issues similar to those before the Court," the judge claimed:
This Court is ill-equipped to make this determination... ultimately it is FDA, not this Court, that possesses the expertise to evaluate scientific evidence and make public health judgments...
FDA’s review should be conducted and completed free from judicial interference.
The judge ordered the matter "STAYED pending completion of FDA’s ongoing review" but would only afford FDA a "time limited period of deference to complete its review," writing that the "stay granted to FDA will not remain open-ended."
He ordered:
60 Days: FDA must produce entirety of the administrative record to Plaintiffs’ counsel.
6 Months: FDA must file a report providing the Court with the status of its review.
14 Days: After FDA completes its REMS review, FDA shall file a brief advising the Court of any agency action.
"Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change," the judge wrote.
In response, the State of Louisiana has appealed the 'stay' to the United States Court of Appeals for the Fifth Circuit.
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!
Abortion Pill
Carole Novielli
·
Analysis
Nancy Flanders
·
Abortion Pill
Bridget Sielicki
·Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Nancy Flanders
·
Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Analysis
Nancy Flanders
·Abortion Pill
Bridget Sielicki
·Abortion Pill
Nancy Flanders
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·
Analysis
Carole Novielli
·"This is the first federal court decision that outright says that states like Louisiana are suffering irreparable, sovereign harm every day that this 2023 REMS... remains in effect." Ben Aguiñaga, Solicitor General of Louisiana, reacts to this week's chemical abortion ruling.
"This is the first federal court decision that outright says that states like Louisiana are suffering irreparable, sovereign harm every day that this 2023 REMS... remains in effect." Ben Aguiñaga, Solicitor General of Louisiana, reacts to this week's chemical abortion ruling.
A Louisiana federal court agrees with what @AGLizMurrill and I have said: Biden’s reckless mail-order abortion drug policy hurts Louisiana and endangers women. It's time the FDA stops dragging its feet on the safety review and reinstates the in-person dispensing requirement. Show more
Absolutely. Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect. Accordingly, under binding Fifth
A Louisiana federal court agrees with what @AGLizMurrill and I have said: Biden’s reckless mail-order abortion drug policy hurts Louisiana and endangers women. It's time the FDA stops dragging its feet on the safety review and reinstates the in-person dispensing requirement. Show more
Absolutely. Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect. Accordingly, under binding Fifth
Absolutely. Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect. Accordingly, under binding Fifth Show more
Absolutely. Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect. Accordingly, under binding Fifth Show more
Absolutely. Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect. Accordingly, under binding Fifth Show more
Absolutely. Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect. Accordingly, under binding Fifth Show more
