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
'Without guardrails': Abortion pill report exposes stunning lack of accountability
An extensive report, "Mifepristone Without Guardrails: An Investigation Into How Chemical Abortion Drug Makers Are Putting Mothers and Babies At Risk," appears to confirm that, despite multiple examples of certified prescribers being out of compliance with the Food and Drug Administration's safety requirements for the abortion pill, manufacturers have not decertified a single one.
Despite the fact that the manufacturers of the abortion pill are obligated to ensure that the FDA's safety rules are followed by prescribers of the drug and pharmacies dispensing the drug, it appears the manufacturers are sending mixed messages about whether or not they actually have this responsibility.
It appears that when the rules are broken by prescribers, virtually no one is decertified, and that it is left to the non-compliant prescribers to report themselves for de-certification. In other words, no one is holding prescribers who break the FDA's safety rules accountable.
The investigation and report revealed that in Danco's decades of operation as a sponsor under the FDA's safety rules, "[t]o date, no healthcare providers have been decertified from the REMS, and two pharmacies were decertified during the REMS assessment period of October 1, 2024 to September 30, 2025."
Manufacturer GenBioPro reported that it also "has not had cause to decertify any certified prescriber or certified pharmacy since the launch of GBP’s generic mifepristone in 2019.
Despite this, these drug manufacturers actually link to non-compliant prescribers on their own websites.
Groups like AbortionFinder, Planned Parenthood, and Carafem are all publicly and openly flouting the FDA's rules and prescribing/dispensing outside these boundaries, yet they have never been decertified. These violations including prescribing to women "just in case" (without a confirmed pregnancy), advertising and prescribing mifepristone past the FDA-approved gestational age of 10 weeks, and more.
The August 2026 report, led by Senator Bill Cassidy for the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, states that the Committee's investigation found "a consistent pattern of a lack of transparency regarding the operations of mifepristone sponsors," raising "critical questions about the effectiveness of their oversight of the supply chain for their drugs and prescribers to ensure compliance with REMS [Risk Evaluation and Mitigation Strategy] requirements."
Despite the fact that the manufacturers of the drug are obligated to ensure that the rules are followed, it appears they have washed their hands of any involvement. In other words, no one is ensuring that the safety rules are being followed — and if rules are broken, no one is being decertified:
Under the current Mifepristone REMS Program, the mifepristone sponsors have the responsibility of ensuring REMS requirements are being complied with.
Yet that responsibility, by the sponsors’ telling, only extends as far as overseeing distributor and pharmacy behavior and simply making sure certification forms are submitted.
Given that these oversight requirements do not extend to the mifepristone prescribing patterns of certified prescribers, the lack of guardrails ensuring a sufficient provider-patient relationship creates accountability gaps for a product that carries risks of significant adverse health outcomes.
That not a single prescriber has been decertified in the entire history of the Mifepristone REMS Program solidifies this point.
The REMS safety rules for mifepristone (200mg)/Mifeprex were put in place in 2011, more than a decade after the abortion pill was originally 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.
Sponsors (manufacturers) of the drug include Danco Laboratories, GenBioPro (GBP), and Evita Solutions, LLC. As Live Action News previously detailed, these businesses are tasked with training, certifying, and decertifying prescribers who are out of compliance with the REMS.
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.
The REMS safety requirements for mifepristone state (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."
Pharmacy certification is a separate process and is also policed by the drug's sponsors.
According to the report:
Danco has certified 5,250 prescribers and 5,297 pharmacies.
GBP has certified 2,950 prescribers and 127 pharmacies.
Evita has certified zero prescribers and only two pharmacies.
In his press release, Senator Cassidy pointed out how abortion pill sponsors told the Committee they have no role in policing the prescribers of the drug, contradicting the FDA's REMS agreement (emphasis added):
In the course of the investigation, Danco and GenBioPro told the Committee that they have no role in ensuring that doctors and other health care providers who prescribe chemical abortion drugs maintain compliance with the FDA requirements, implying that the onus is on the prescribers to police themselves.
Given the lack of oversight, there are concerns that these sponsors are disregarding the safety risks of chemical abortions and either overtly or tacitly allowing their products to be sold to bad actors who seek to exploit women for profit.
And yet, contrary to what the Committee was verbally told in a hearing, a letter from Danco later acknowledged that it "is obligated to decertify healthcare providers who do not maintain compliance with the REMS certification requirements" and "is required to report to FDA any instances of prescriber decertification, including the reasons for decertification, and must alert its distributors not to ship to decertified prescribers."
In follow-up, Danco wrote:
"Danco does not automatically decertify prescribers in states where abortion is severely restricted by state law... In accordance with its REMS obligations as approved by FDA, Danco will decertify a prescriber if Danco becomes aware, and agrees, that the healthcare provider has failed to maintain compliance with the certification requirements for prescribing Mifeprex...
To date, no healthcare providers have been decertified from the REMS, and two pharmacies were decertified during the REMS assessment period of October 1, 2024 to September 30, 2025."
GenBioPro likewise wrote, "GBP has not had cause to decertify any certified prescriber or certified pharmacy since the launch of GBP’s generic mifepristone in 2019." It added:
GBP complies with its obligations under the REMS. If an actual or suspected instance of prescriber non-compliance were brought to GBP’s attention, GBP would investigate and respond appropriately, including by decertifying the prescriber if the prescriber will not comply with the REMS certification requirements.
The August 2026 report made it clear that sponsors of the drug are to not only police but decertify non-compliant prescribers and pharmacies. Yet, while manufacturers acknowledged to decertifying some pharmacies, they have never decertified any prescribers:
The REMS requires mifepristone sponsors to decertify health care providers and pharmacies that “do not maintain compliance with certification requirements.”
Danco has decertified two pharmacies, both between October 2024 and September 2025—the authorized representative for one pharmacy did not participate in a required audit and requested decertification, and the other pharmacy was determined to be an in-patient facility whose activities should be conducted under an individual prescriber certification and not a pharmacy certification, so that account was put on hold until the Prescriber Agreement Form was completed and received.
GBP has never decertified any pharmacies. GBP further stated that all instances of pharmacy noncompliance found through audits were able to be resolved through corrective actions.
The report points out:
Notably, Danco and GBP both reported that neither has ever decertified a certified prescriber. GBP further stated that it has never identified any certified prescriber noncompliance with the REMS certification requirements.
Danco did not address whether it has ever identified any certified prescriber noncompliance with the REMS.
If GBP has never observed any noncompliance with the REMS requirements among its thousands of certified prescribers, this may indicate a lack of visibility into the prescribing patterns of certified prescribers to verify compliance.
Authors of the report acknowledged:
"[I]t is no wonder that Danco has never decertified a single prescriber when it claims to never take steps to confirm that the prescribers are actually meeting the requirements they attest to."
The report noted that "GBP, similarly to Danco, refused to provide any information as to how it monitors prescribers and ensures the attestations made in the Prescriber Agreement Form are correct and complied with on an ongoing basis," adding that, "like Danco, GBP has never decertified a single prescriber in over seven years of having its drug on the market" (emphasis added).
It strains credulity that when prescribers of the abortion pill are openly, publicly flouting REMS safety rules that the manufacturers somehow aren't aware of this... especially when the manufacturers' websites link directly to these prescribers in many cases.
Live Action News has previously documented that abortion drug companies themselves (Danco, GenBioPro, and Evita Solutions) are linking to websites that advertise abortions past the FDA-approved 10-week gestational limits under REMS, and which are, in some instances, failing to confirm pregnancy before prescribing the drug, among other unaccountable violations.
A few examples:
➡ AbortionFinder.org: "[S]ome [prescribers] will offer it through around 14 weeks of pregnancy ..."
➡ Planned Parenthood: Advertises the abortion pill past 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.”
PP separately acknowledges 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 announced one affiliate's launch of Just In Case Abortion Pills so women can "have them on hand if and when they need them." And this PP affiliate isn't alone (emphasis added):
"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."
Also mentioned in the report was a video posted by Dr. Christina Francis of the American Association of Pro-Life OBGYNs (AAPLOG), showing potential REMS violations. The HELP Committee noted that the video "demonstrates how multiple REMS requirements were likely violated by Aid Access’s participating prescribers."
While the report claimed, "Aid Access itself is not a certified prescriber," it suggested the group's doctors could be, because "the mifepristone that Dr. Francis received... from Aid Access was GBP’s generic mifepristone product."
The report stated (emphases added):
Aid Access’s prescribing and dispensing process raised a number of red flags....
If... the prescriber was not certified, the prescribing and dispensing of GBP’s mifepristone would themselves be violations of the REMS because the drug was accessed outside certified channels.If this is the case, it indicates either that GBP does not have adequate insight into the supply chain and prescribing of its drug or, perhaps even more concerningly, that it may be aware of these types of arrangements and complicit in them...
...While this is just one example, it shows that prescribers, especially online-only prescribers, may not always comply with the REMS requirements they agreed to when signing the Prescriber Agreement Form.
... It is highly likely that Danco and GBP are aware of the existence of these types of websites, but do not conduct oversight into whether these websites operate outside of the certified prescriber process or, if they do rely on certified prescribers, if those individuals are actually complying with the requirements of the REMS and Prescriber Agreement Form.
The report noted (emphases added):
These findings together demonstrate that once a prescriber submits a Prescriber Agreement Form to a mifepristone sponsor, instances of noncompliance with REMS requirements (beyond completion of required paperwork) are unlikely to be identified unless the prescriber self-reports the violation.
The fact that no prescriber has ever been decertified underscores this point further.
The report added that the way Aid Access and other sites present themselves as "FDA approved" is misleading, and "provides a false sense of security to patients and denies them the protections mandated by the REMS to ensure the drug is being prescribed in a way that minimizes the risk of adverse events" (emphasis added).
Interestingly, the report didn't just lay blame on the manufacturers -- it called out the FDA, stating, "It is also an indictment of FDA that the agency would continuously approve a REMS that did not require any sort of oversight into the prescribers, given the well documented history of mifepristone marketing and access in violation of the REMS."
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.
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Abortion Pill·By Carole Novielli
'Without guardrails': Abortion pill report exposes stunning lack of accountability
An extensive report, "Mifepristone Without Guardrails: An Investigation Into How Chemical Abortion Drug Makers Are Putting Mothers and Babies At Risk," appears to confirm that, despite multiple examples of certified prescribers being out of compliance with the Food and Drug Administration's safety requirements for the abortion pill, manufacturers have not decertified a single one.
Despite the fact that the manufacturers of the abortion pill are obligated to ensure that the FDA's safety rules are followed by prescribers of the drug and pharmacies dispensing the drug, it appears the manufacturers are sending mixed messages about whether or not they actually have this responsibility.
It appears that when the rules are broken by prescribers, virtually no one is decertified, and that it is left to the non-compliant prescribers to report themselves for de-certification. In other words, no one is holding prescribers who break the FDA's safety rules accountable.
The investigation and report revealed that in Danco's decades of operation as a sponsor under the FDA's safety rules, "[t]o date, no healthcare providers have been decertified from the REMS, and two pharmacies were decertified during the REMS assessment period of October 1, 2024 to September 30, 2025."
Manufacturer GenBioPro reported that it also "has not had cause to decertify any certified prescriber or certified pharmacy since the launch of GBP’s generic mifepristone in 2019.
Despite this, these drug manufacturers actually link to non-compliant prescribers on their own websites.
Groups like AbortionFinder, Planned Parenthood, and Carafem are all publicly and openly flouting the FDA's rules and prescribing/dispensing outside these boundaries, yet they have never been decertified. These violations including prescribing to women "just in case" (without a confirmed pregnancy), advertising and prescribing mifepristone past the FDA-approved gestational age of 10 weeks, and more.
The August 2026 report, led by Senator Bill Cassidy for the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, states that the Committee's investigation found "a consistent pattern of a lack of transparency regarding the operations of mifepristone sponsors," raising "critical questions about the effectiveness of their oversight of the supply chain for their drugs and prescribers to ensure compliance with REMS [Risk Evaluation and Mitigation Strategy] requirements."
Despite the fact that the manufacturers of the drug are obligated to ensure that the rules are followed, it appears they have washed their hands of any involvement. In other words, no one is ensuring that the safety rules are being followed — and if rules are broken, no one is being decertified:
Under the current Mifepristone REMS Program, the mifepristone sponsors have the responsibility of ensuring REMS requirements are being complied with.
Yet that responsibility, by the sponsors’ telling, only extends as far as overseeing distributor and pharmacy behavior and simply making sure certification forms are submitted.
Given that these oversight requirements do not extend to the mifepristone prescribing patterns of certified prescribers, the lack of guardrails ensuring a sufficient provider-patient relationship creates accountability gaps for a product that carries risks of significant adverse health outcomes.
That not a single prescriber has been decertified in the entire history of the Mifepristone REMS Program solidifies this point.
The REMS safety rules for mifepristone (200mg)/Mifeprex were put in place in 2011, more than a decade after the abortion pill was originally 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.
Sponsors (manufacturers) of the drug include Danco Laboratories, GenBioPro (GBP), and Evita Solutions, LLC. As Live Action News previously detailed, these businesses are tasked with training, certifying, and decertifying prescribers who are out of compliance with the REMS.
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.
The REMS safety requirements for mifepristone state (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."
Pharmacy certification is a separate process and is also policed by the drug's sponsors.
According to the report:
Danco has certified 5,250 prescribers and 5,297 pharmacies.
GBP has certified 2,950 prescribers and 127 pharmacies.
Evita has certified zero prescribers and only two pharmacies.
In his press release, Senator Cassidy pointed out how abortion pill sponsors told the Committee they have no role in policing the prescribers of the drug, contradicting the FDA's REMS agreement (emphasis added):
In the course of the investigation, Danco and GenBioPro told the Committee that they have no role in ensuring that doctors and other health care providers who prescribe chemical abortion drugs maintain compliance with the FDA requirements, implying that the onus is on the prescribers to police themselves.
Given the lack of oversight, there are concerns that these sponsors are disregarding the safety risks of chemical abortions and either overtly or tacitly allowing their products to be sold to bad actors who seek to exploit women for profit.
And yet, contrary to what the Committee was verbally told in a hearing, a letter from Danco later acknowledged that it "is obligated to decertify healthcare providers who do not maintain compliance with the REMS certification requirements" and "is required to report to FDA any instances of prescriber decertification, including the reasons for decertification, and must alert its distributors not to ship to decertified prescribers."
In follow-up, Danco wrote:
"Danco does not automatically decertify prescribers in states where abortion is severely restricted by state law... In accordance with its REMS obligations as approved by FDA, Danco will decertify a prescriber if Danco becomes aware, and agrees, that the healthcare provider has failed to maintain compliance with the certification requirements for prescribing Mifeprex...
To date, no healthcare providers have been decertified from the REMS, and two pharmacies were decertified during the REMS assessment period of October 1, 2024 to September 30, 2025."
GenBioPro likewise wrote, "GBP has not had cause to decertify any certified prescriber or certified pharmacy since the launch of GBP’s generic mifepristone in 2019." It added:
GBP complies with its obligations under the REMS. If an actual or suspected instance of prescriber non-compliance were brought to GBP’s attention, GBP would investigate and respond appropriately, including by decertifying the prescriber if the prescriber will not comply with the REMS certification requirements.
The August 2026 report made it clear that sponsors of the drug are to not only police but decertify non-compliant prescribers and pharmacies. Yet, while manufacturers acknowledged to decertifying some pharmacies, they have never decertified any prescribers:
The REMS requires mifepristone sponsors to decertify health care providers and pharmacies that “do not maintain compliance with certification requirements.”
Danco has decertified two pharmacies, both between October 2024 and September 2025—the authorized representative for one pharmacy did not participate in a required audit and requested decertification, and the other pharmacy was determined to be an in-patient facility whose activities should be conducted under an individual prescriber certification and not a pharmacy certification, so that account was put on hold until the Prescriber Agreement Form was completed and received.
GBP has never decertified any pharmacies. GBP further stated that all instances of pharmacy noncompliance found through audits were able to be resolved through corrective actions.
The report points out:
Notably, Danco and GBP both reported that neither has ever decertified a certified prescriber. GBP further stated that it has never identified any certified prescriber noncompliance with the REMS certification requirements.
Danco did not address whether it has ever identified any certified prescriber noncompliance with the REMS.
If GBP has never observed any noncompliance with the REMS requirements among its thousands of certified prescribers, this may indicate a lack of visibility into the prescribing patterns of certified prescribers to verify compliance.
Authors of the report acknowledged:
"[I]t is no wonder that Danco has never decertified a single prescriber when it claims to never take steps to confirm that the prescribers are actually meeting the requirements they attest to."
The report noted that "GBP, similarly to Danco, refused to provide any information as to how it monitors prescribers and ensures the attestations made in the Prescriber Agreement Form are correct and complied with on an ongoing basis," adding that, "like Danco, GBP has never decertified a single prescriber in over seven years of having its drug on the market" (emphasis added).
It strains credulity that when prescribers of the abortion pill are openly, publicly flouting REMS safety rules that the manufacturers somehow aren't aware of this... especially when the manufacturers' websites link directly to these prescribers in many cases.
Live Action News has previously documented that abortion drug companies themselves (Danco, GenBioPro, and Evita Solutions) are linking to websites that advertise abortions past the FDA-approved 10-week gestational limits under REMS, and which are, in some instances, failing to confirm pregnancy before prescribing the drug, among other unaccountable violations.
A few examples:
➡ AbortionFinder.org: "[S]ome [prescribers] will offer it through around 14 weeks of pregnancy ..."
➡ Planned Parenthood: Advertises the abortion pill past 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.”
PP separately acknowledges 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 announced one affiliate's launch of Just In Case Abortion Pills so women can "have them on hand if and when they need them." And this PP affiliate isn't alone (emphasis added):
"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."
Also mentioned in the report was a video posted by Dr. Christina Francis of the American Association of Pro-Life OBGYNs (AAPLOG), showing potential REMS violations. The HELP Committee noted that the video "demonstrates how multiple REMS requirements were likely violated by Aid Access’s participating prescribers."
While the report claimed, "Aid Access itself is not a certified prescriber," it suggested the group's doctors could be, because "the mifepristone that Dr. Francis received... from Aid Access was GBP’s generic mifepristone product."
The report stated (emphases added):
Aid Access’s prescribing and dispensing process raised a number of red flags....
If... the prescriber was not certified, the prescribing and dispensing of GBP’s mifepristone would themselves be violations of the REMS because the drug was accessed outside certified channels.If this is the case, it indicates either that GBP does not have adequate insight into the supply chain and prescribing of its drug or, perhaps even more concerningly, that it may be aware of these types of arrangements and complicit in them...
...While this is just one example, it shows that prescribers, especially online-only prescribers, may not always comply with the REMS requirements they agreed to when signing the Prescriber Agreement Form.
... It is highly likely that Danco and GBP are aware of the existence of these types of websites, but do not conduct oversight into whether these websites operate outside of the certified prescriber process or, if they do rely on certified prescribers, if those individuals are actually complying with the requirements of the REMS and Prescriber Agreement Form.
The report noted (emphases added):
These findings together demonstrate that once a prescriber submits a Prescriber Agreement Form to a mifepristone sponsor, instances of noncompliance with REMS requirements (beyond completion of required paperwork) are unlikely to be identified unless the prescriber self-reports the violation.
The fact that no prescriber has ever been decertified underscores this point further.
The report added that the way Aid Access and other sites present themselves as "FDA approved" is misleading, and "provides a false sense of security to patients and denies them the protections mandated by the REMS to ensure the drug is being prescribed in a way that minimizes the risk of adverse events" (emphasis added).
Interestingly, the report didn't just lay blame on the manufacturers -- it called out the FDA, stating, "It is also an indictment of FDA that the agency would continuously approve a REMS that did not require any sort of oversight into the prescribers, given the well documented history of mifepristone marketing and access in violation of the REMS."
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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