Abortion Pill
'Louisiana needs relief now': Oral arguments complete in state's abortion pill case against FDA
Carole Novielli
·Spotlight Articles
Abortion Pill·By Carole Novielli
UNACCOUNTABLE: Big Abortion breaks abortion pill rules, but no one seems to care
Abortion pill manufacturers do not appear to be properly policing or decertifying prescribers who are out of compliance with the Food and Drug Administration's (FDA)'s safety requirements for mifepristone (200 mg)/Mifeprex. And according to the FDA, they are required to do so.
The FDA has specific requirements for prescribers of the abortion pill, listed under its safety requirements, known as REMS. Prescribers must have the ability to confirm pregnancy, to handle abortion pill complications, to properly rule out ectopic pregnancies, and must also prescribe the abortion pill within FDA-approved gestational limits.
Abortion pill manufacturers (also known as "sponsors" — Danco Laboratories, GenBioPro, and Evita Solutions, LLC — appear to be allowing certified prescribers of the drug to violate FDA protocol without decertifying them, as is required.
Sponsors are tasked with training, certifying, and decertifying out of compliance prescribers.
The FDA says sponsors must "[e]nsure that healthcare providers who prescribe their mifepristone are specially certified in accordance with the requirements… and de-certify healthcare providers who do not maintain compliance with certification requirements."
Prescribers must sign a Prescriber Agreement Form, agreeing that they have the ability to assess the duration of pregnancy accurately, diagnose ectopic pregnancies, provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary." They must also agree that "they will follow the guidelines for use of mifepristone."
Multiple prescribers are dispensing abortion pills past FDA-approved gestational limits, and some are dispensing them to women who are not pregnant.
Though prescribers are required to have the ability to "provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others," the abortion industry has, for decades, participated in a scheme to hide abortion pill complications by instructing women at the point of sale to present to the ER and lie, claiming a natural miscarriage instead.
The FDA says that "REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication." If the safety protocol isn't followed and no one is decertified as a result, then no one is ensuring the "safe use" of mifepristone.
The safety protocol, or Risk Evaluation and Mitigation Strategy (REMS), for mifepristone was put in place in 2011, more than a decade after the abortion pill was approved by the FDA in 2000 and after multiple women had died in association with use of the abortion pill regimen. The most recently published REMS for mifepristone is dated September 2025.
The FDA's website explains:
The drug safety protocol is something the FDA "can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks."
The "REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication."
If the safety protocol isn't followed and no one is decertified as a result, then no one is ensuring the "safe use" of mifepristone. The goal of REMS is to mitigate the risk of serious complications associated with mifepristone.
The abortion pill was originally for use up to 7 weeks of pregnancy in a regimen along with the drug misoprostol. It was later expanded to allow for its use through 10 weeks/70 days gestation.
"Sponsors" are the drug's manufacturers. Abortion pill prescribers are certified by the following sponsors:
Danco Laboratories: A secretive, single-entity company which oversees the manufacturing of Mifeprex. Danco was recently forced by law to reveal that the drug is currently manufactured in Spain.
GenBioPro (GBP): Oversees manufacturing of the generic abortion drug — mifepristone (200mg) — which was approved in 2019 by the Trump FDA. GBP manufactures generic versions of both drugs, mifepristone and misoprostol.
Evita Solutions, LLC the second generic abortion pill was approved by the Trump FDA in 2025. Like Danco, their company is also fairly secretive.
Sponsors are tasked with training, certifying and decertifying out of compliance prescribers.
Mifepristone sponsors must:
Ensure that healthcare providers who prescribe their mifepristone are specially certified in accordance with the requirements…and de-certify healthcare providers who do not maintain compliance with certification requirements.
Prescribers are approved and certified to dispense the abortion pill by one (or more) of the three U.S. sponsors (manufacturers) of the drug; however, there is no public list specifying which sponsor approved which prescriber.
The REMS for mifepristone states (emphasis added):
By signing a Prescriber Agreement Form, prescribers agree they have ability to:
a) assess the duration of pregnancy accurately
b) diagnose ectopic pregnancies
c) provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary
They must also agree that "they will follow the guidelines for use of mifepristone."
Some prescribers are advertising and even distributing abortion pills well beyond the FDA's 10-week limit. Some are selling pills "just in case" a woman becomes pregnant. This looks nothing like an attempt to comply with having the ability to assess the duration of a woman's pregnancy.
The REMS is clear that prescribers must have the "ability to assess the duration of pregnancy accurately."
The Prescriber Agreement specifies that mifepristone is "indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation."
This is confirmed by the FDA website, the drug’s March 2023 label, and REMS documents.
Danco, GenBioPro, and Evita Solutions websites all acknowledge these gestational limits.
➡ The National Abortion Federation (NAF) claims "Providers who mail pills may send different medication regimens."
The abortion industry has been:
prescribing the abortion pill "just in case" in "advance" of confirmed pregnancy.
selling the pill for "future use."
selling it as "missed period" pills.
advertising its use into the second trimester or third trimester, despite its increased rate of failure as pregnancy advances.
In 2023, Dr. Linda Prine, co-founder of the Miscarriage and Abortion Hotline, told Vox News
“The pills are approved by the FDA for up to 10 weeks… Most of the time, though, they’ve been used in our country under eight weeks... But now, they’re using them whenever they can get them. And sometimes that is quite a bit later. Sometimes it’s 14 weeks, 18 weeks. And so we get calls from people completely freaked out, crying, sobbing.” [emphasis added]
AbortionFinder.org states clearly that "some [prescribers] will offer it through around 14 weeks of pregnancy ..."
➡ Planned Parenthood advertises the abortion pill past the approved gestational limits: "In general, you can have a medication abortion up to 84 days (12 weeks) after the first day of your last period.”
They separately acknowledge that "The abortion pill... works less well when you’re more than 8 weeks pregnant.... After 12 weeks, there’s a bigger chance of stronger bleeding or cramps."
A news release published by Planned Parenthood Great Northwest, Hawai‘i, Alaska, Indiana, Kentucky (PPGNHAIK) announced the launch of Just In Case Abortion Pills so women can "have them on hand if and when they need them."
"PPGNHAIK joins a growing number of sexual and reproductive health care providers offering this model of care."
Planned Parenthood’s general “abortion services” website page reiterates this: “Some Planned Parenthood health centers offer abortion pills before you’re pregnant — just in case you need them.”
➡ Carafem, a study site for abortion pill clinical trials, advertises “missed period pills” as “FDA-approved abortion medications..."
On a separate webpage, it claims, “Missed period pills are safe, evidence-based care."
Yet, the drug has never been approved as a "missed period pill."
Plan C advertises multiple companies that it claims will prescribe abortion pills "for future use" against REMS.
Danco, GenBioPro, and Evita Solutions all link to Abortion Finder, Planned Parenthood, and others who refer to non-compliant prescribers.
And yet, Danco’s emergency application before the Supreme Court claimed it "understands the law to require Mifeprex to have an approved REMS and to be distributed in accordance with that REMS."
"MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies," wrote Danco.
Prescribers are required under REMS to have the “[a]bility to diagnose ectopic pregnancies.” The abortion pill's label notes potential serious complications, including a black box warning for sepsis risk.
The abortion industry, by its own admission, does not rule out ectopic pregnancy for each woman seeking the abortion pill. This places the woman at risk for potentially life-threatening complications.
In 2020, when the abortion industry implemented the “no-test” protocol, it did so despite openly admitting that the abortion pill's 'no-test' criteria would not rule out “every ectopic pregnancy” — meaning ectopics would be detected sometime "after treatment….”
In correspondence to the New England Journal of Medicine, emergency room physicians alerted staff to a potential increase in undiagnosed ectopic pregnancy cases due to the no-test protocol used by most prescribers.
REMS requires that prescribers have the...
[a]bility to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Instead of providing intervention, for decades, the abortion industry has participated in a scheme to hide abortion pill complications by instructing women at the point of sale to present to the ER and lie, claiming a natural miscarriage instead.
Disturbing Examples (emphases added):
Dr. Franz Theard advised an abortion client to lie and instead claim a natural miscarriage: watch video here.
INeedanA: “If you're having a medical emergency... You don't need to say anything about taking abortion pills or why you think you might be bleeding.”
Abortion pill provider Southern Woven: “You are never required to disclose that you took abortion pills to get emergency care. It is both legal and medically safe to say you are having a miscarriage… Telling a provider 'I'm having a miscarriage' or 'I'm bleeding and I don't know why' is accurate and gets you proper care.”
Roxy Clinic: “If you need medical care after taking abortion pills... You don't have to tell the provider you took pills. Saying 'I think I'm having a miscarriage' or 'I'm bleeding and I was pregnant' is completely true and leads to exactly the same clinical workup and treatment.”
Women’s Reproductive Clinic of New Mexico: "If you go to the ER, tell them you think you are having a miscarriage."
Planned Parenthood claims, "An incomplete abortion is generally treated the same way as an incomplete miscarriage, even if you live in a state with abortion bans. So it’s up to you to decide whether you want to tell your nurse or doctor about your abortion."
💊 This has been going on for years and years; if women follow this advice, none of the complications they experience will be attributed to the abortion pill.
Medical malpractice attorney Michael Seibel wrote that the "evidence suggests widespread non-enforcement":
"Studies of abortion-seeking patients show that while many can self-assess early gestation reasonably well, the error rate is non-trivial, and the REMS places the accuracy obligation on the certified prescriber."
Seibel, who operates the website AbortionInjury.com, added:
"The FDA is the primary regulator, but private plaintiffs harmed by alleged violations have standing to seek remedies when manufacturers breach duties that directly protect patients.
A class action focused on systemic failure to enforce the prescriber and pharmacy agreements could... force the companies to either police their network rigorously or face financial consequences... that leave women exposed to the very risks the REMS was designed to prevent.
Plaintiffs’ attorneys who care about patient safety... should examine the REMS enforcement records, distribution data, and adverse-event reports.
The manufacturers have the contractual and regulatory tools; the question is whether they are using them. If not, the courts are an appropriate venue to hold them accountable."
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
UNACCOUNTABLE: Big Abortion breaks abortion pill rules, but no one seems to care
Abortion pill manufacturers do not appear to be properly policing or decertifying prescribers who are out of compliance with the Food and Drug Administration's (FDA)'s safety requirements for mifepristone (200 mg)/Mifeprex. And according to the FDA, they are required to do so.
The FDA has specific requirements for prescribers of the abortion pill, listed under its safety requirements, known as REMS. Prescribers must have the ability to confirm pregnancy, to handle abortion pill complications, to properly rule out ectopic pregnancies, and must also prescribe the abortion pill within FDA-approved gestational limits.
Abortion pill manufacturers (also known as "sponsors" — Danco Laboratories, GenBioPro, and Evita Solutions, LLC — appear to be allowing certified prescribers of the drug to violate FDA protocol without decertifying them, as is required.
Sponsors are tasked with training, certifying, and decertifying out of compliance prescribers.
The FDA says sponsors must "[e]nsure that healthcare providers who prescribe their mifepristone are specially certified in accordance with the requirements… and de-certify healthcare providers who do not maintain compliance with certification requirements."
Prescribers must sign a Prescriber Agreement Form, agreeing that they have the ability to assess the duration of pregnancy accurately, diagnose ectopic pregnancies, provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary." They must also agree that "they will follow the guidelines for use of mifepristone."
Multiple prescribers are dispensing abortion pills past FDA-approved gestational limits, and some are dispensing them to women who are not pregnant.
Though prescribers are required to have the ability to "provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others," the abortion industry has, for decades, participated in a scheme to hide abortion pill complications by instructing women at the point of sale to present to the ER and lie, claiming a natural miscarriage instead.
The FDA says that "REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication." If the safety protocol isn't followed and no one is decertified as a result, then no one is ensuring the "safe use" of mifepristone.
The safety protocol, or Risk Evaluation and Mitigation Strategy (REMS), for mifepristone was put in place in 2011, more than a decade after the abortion pill was approved by the FDA in 2000 and after multiple women had died in association with use of the abortion pill regimen. The most recently published REMS for mifepristone is dated September 2025.
The FDA's website explains:
The drug safety protocol is something the FDA "can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks."
The "REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication."
If the safety protocol isn't followed and no one is decertified as a result, then no one is ensuring the "safe use" of mifepristone. The goal of REMS is to mitigate the risk of serious complications associated with mifepristone.
The abortion pill was originally for use up to 7 weeks of pregnancy in a regimen along with the drug misoprostol. It was later expanded to allow for its use through 10 weeks/70 days gestation.
"Sponsors" are the drug's manufacturers. Abortion pill prescribers are certified by the following sponsors:
Danco Laboratories: A secretive, single-entity company which oversees the manufacturing of Mifeprex. Danco was recently forced by law to reveal that the drug is currently manufactured in Spain.
GenBioPro (GBP): Oversees manufacturing of the generic abortion drug — mifepristone (200mg) — which was approved in 2019 by the Trump FDA. GBP manufactures generic versions of both drugs, mifepristone and misoprostol.
Evita Solutions, LLC the second generic abortion pill was approved by the Trump FDA in 2025. Like Danco, their company is also fairly secretive.
Sponsors are tasked with training, certifying and decertifying out of compliance prescribers.
Mifepristone sponsors must:
Ensure that healthcare providers who prescribe their mifepristone are specially certified in accordance with the requirements…and de-certify healthcare providers who do not maintain compliance with certification requirements.
Prescribers are approved and certified to dispense the abortion pill by one (or more) of the three U.S. sponsors (manufacturers) of the drug; however, there is no public list specifying which sponsor approved which prescriber.
The REMS for mifepristone states (emphasis added):
By signing a Prescriber Agreement Form, prescribers agree they have ability to:
a) assess the duration of pregnancy accurately
b) diagnose ectopic pregnancies
c) provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary
They must also agree that "they will follow the guidelines for use of mifepristone."
Some prescribers are advertising and even distributing abortion pills well beyond the FDA's 10-week limit. Some are selling pills "just in case" a woman becomes pregnant. This looks nothing like an attempt to comply with having the ability to assess the duration of a woman's pregnancy.
The REMS is clear that prescribers must have the "ability to assess the duration of pregnancy accurately."
The Prescriber Agreement specifies that mifepristone is "indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation."
This is confirmed by the FDA website, the drug’s March 2023 label, and REMS documents.
Danco, GenBioPro, and Evita Solutions websites all acknowledge these gestational limits.
➡ The National Abortion Federation (NAF) claims "Providers who mail pills may send different medication regimens."
The abortion industry has been:
prescribing the abortion pill "just in case" in "advance" of confirmed pregnancy.
selling the pill for "future use."
selling it as "missed period" pills.
advertising its use into the second trimester or third trimester, despite its increased rate of failure as pregnancy advances.
In 2023, Dr. Linda Prine, co-founder of the Miscarriage and Abortion Hotline, told Vox News
“The pills are approved by the FDA for up to 10 weeks… Most of the time, though, they’ve been used in our country under eight weeks... But now, they’re using them whenever they can get them. And sometimes that is quite a bit later. Sometimes it’s 14 weeks, 18 weeks. And so we get calls from people completely freaked out, crying, sobbing.” [emphasis added]
AbortionFinder.org states clearly that "some [prescribers] will offer it through around 14 weeks of pregnancy ..."
➡ Planned Parenthood advertises the abortion pill past the approved gestational limits: "In general, you can have a medication abortion up to 84 days (12 weeks) after the first day of your last period.”
They separately acknowledge that "The abortion pill... works less well when you’re more than 8 weeks pregnant.... After 12 weeks, there’s a bigger chance of stronger bleeding or cramps."
A news release published by Planned Parenthood Great Northwest, Hawai‘i, Alaska, Indiana, Kentucky (PPGNHAIK) announced the launch of Just In Case Abortion Pills so women can "have them on hand if and when they need them."
"PPGNHAIK joins a growing number of sexual and reproductive health care providers offering this model of care."
Planned Parenthood’s general “abortion services” website page reiterates this: “Some Planned Parenthood health centers offer abortion pills before you’re pregnant — just in case you need them.”
➡ Carafem, a study site for abortion pill clinical trials, advertises “missed period pills” as “FDA-approved abortion medications..."
On a separate webpage, it claims, “Missed period pills are safe, evidence-based care."
Yet, the drug has never been approved as a "missed period pill."
Plan C advertises multiple companies that it claims will prescribe abortion pills "for future use" against REMS.
Danco, GenBioPro, and Evita Solutions all link to Abortion Finder, Planned Parenthood, and others who refer to non-compliant prescribers.
And yet, Danco’s emergency application before the Supreme Court claimed it "understands the law to require Mifeprex to have an approved REMS and to be distributed in accordance with that REMS."
"MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies," wrote Danco.
Prescribers are required under REMS to have the “[a]bility to diagnose ectopic pregnancies.” The abortion pill's label notes potential serious complications, including a black box warning for sepsis risk.
The abortion industry, by its own admission, does not rule out ectopic pregnancy for each woman seeking the abortion pill. This places the woman at risk for potentially life-threatening complications.
In 2020, when the abortion industry implemented the “no-test” protocol, it did so despite openly admitting that the abortion pill's 'no-test' criteria would not rule out “every ectopic pregnancy” — meaning ectopics would be detected sometime "after treatment….”
In correspondence to the New England Journal of Medicine, emergency room physicians alerted staff to a potential increase in undiagnosed ectopic pregnancy cases due to the no-test protocol used by most prescribers.
REMS requires that prescribers have the...
[a]bility to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Instead of providing intervention, for decades, the abortion industry has participated in a scheme to hide abortion pill complications by instructing women at the point of sale to present to the ER and lie, claiming a natural miscarriage instead.
Disturbing Examples (emphases added):
Dr. Franz Theard advised an abortion client to lie and instead claim a natural miscarriage: watch video here.
INeedanA: “If you're having a medical emergency... You don't need to say anything about taking abortion pills or why you think you might be bleeding.”
Abortion pill provider Southern Woven: “You are never required to disclose that you took abortion pills to get emergency care. It is both legal and medically safe to say you are having a miscarriage… Telling a provider 'I'm having a miscarriage' or 'I'm bleeding and I don't know why' is accurate and gets you proper care.”
Roxy Clinic: “If you need medical care after taking abortion pills... You don't have to tell the provider you took pills. Saying 'I think I'm having a miscarriage' or 'I'm bleeding and I was pregnant' is completely true and leads to exactly the same clinical workup and treatment.”
Women’s Reproductive Clinic of New Mexico: "If you go to the ER, tell them you think you are having a miscarriage."
Planned Parenthood claims, "An incomplete abortion is generally treated the same way as an incomplete miscarriage, even if you live in a state with abortion bans. So it’s up to you to decide whether you want to tell your nurse or doctor about your abortion."
💊 This has been going on for years and years; if women follow this advice, none of the complications they experience will be attributed to the abortion pill.
Medical malpractice attorney Michael Seibel wrote that the "evidence suggests widespread non-enforcement":
"Studies of abortion-seeking patients show that while many can self-assess early gestation reasonably well, the error rate is non-trivial, and the REMS places the accuracy obligation on the certified prescriber."
Seibel, who operates the website AbortionInjury.com, added:
"The FDA is the primary regulator, but private plaintiffs harmed by alleged violations have standing to seek remedies when manufacturers breach duties that directly protect patients.
A class action focused on systemic failure to enforce the prescriber and pharmacy agreements could... force the companies to either police their network rigorously or face financial consequences... that leave women exposed to the very risks the REMS was designed to prevent.
Plaintiffs’ attorneys who care about patient safety... should examine the REMS enforcement records, distribution data, and adverse-event reports.
The manufacturers have the contractual and regulatory tools; the question is whether they are using them. If not, the courts are an appropriate venue to hold them accountable."
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!
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·Abortion pill usage into 3rd trimester promoted even though the FDA has ONLY APPROVED the drug (mifepristone or mifeprex) up to 10 weeks/ 70 days gestation. Why does FDA allow this @RFKJr_Official? 🧵
Abortion pill usage into 3rd trimester promoted even though the FDA has ONLY APPROVED the drug (mifepristone or mifeprex) up to 10 weeks/ 70 days gestation. Why does FDA allow this @RFKJr_Official? 🧵
