
Safe Haven Baby Boxes announces multiple new locations in four states
Bridget Sielicki
·
Abortion Pill·By Carole Novielli
Big Abortion: Ensuring abortion pill clients are aware of risks is 'not useful'
The abortion industry ("Big Abortion") has long portrayed abortion as part of "healthcare" while simultaneously seeking to carve out special provisions so that abortion and its providers aren't subject to the same scrutiny or standards as the healthcare industry.
Now, it seems the industry isn't concerned that women are ill-informed of potential risks when they take the abortion pill, claiming that requiring them to sign an informative patient agreement form "does not appear to be useful" to Big Abortion's goal of "streamlin[ing]" the way it provides the abortion pill to purchasers.
A recent, non-peer-reviewed JAMA Internal Medicine "study" funded by abortion pill investors and donors claims that the FDA should remove a requirement for abortion pill clients to sign a Patient Agreement Form instructing them on the approved protocols and administration of the drug.
The form requires them to agree that they have been informed about abortion pill risks, including heavy bleeding; infection; potential for fever, pain, or discomfort; and other signs of "a serious infection or another problem (including an ectopic pregnancy)," among other potential complications.
The study of less than 600 participants (from less than half a percent of certified abortion pill prescribers) showed concerning results, especially given the fact that 40% of the women said they had taken the abortion pill before.
Nearly a fourth did not know how long to wait before taking the second drug in the abortion pill regimen, nearly a third didn't know how to properly take the second drug (in the cheeks of the mouth), one-fifth didn't know the possible signs of infection (with most not even knowing they could get an infection from the abortion pill), and 10% had no idea when to seek emergency care.
In addition, 83% thought an incomplete abortion is "rare" when it can be as high as 7%.
The results were also concerning because the study was in person and under strict protocol — which is very unlike real-world use.
Despite all of these results and more, the researchers claimed the form "does not appear to be useful" to "streamlining" provision of the abortion pill.
The proliferation of abortion pills under the Food and Drug Administration's (FDA) now-eroded safety protocols to allow for mail-order and pharmacy dispensing means the abortion industry profits by spending little to no time with abortion clients, doing no follow-up, offloading women to ERs when complications arise, and forcing women to dispose of their own dead children into the toilet (or even the household garbage if the body is too big to flush).
A recent, non-peer-reviewed JAMA Internal Medicine "study," titled "Mifepristone Patient Agreement Form and Medication Abortion Knowledge," was funded by original investors in the abortion pill, and urges the limiting of informed consent by removing the Patient Agreement Form (PAF) required under the FDA's REMS safety system.
The study proposes that the FDA should consider removing the mifepristone Patient Agreement Form (PAF) required for the abortion pill under the REMS safety system, because authors believe the form "does not appear to be useful" to their goal of "streamlin[ing] medication abortion provision."
The Patient Agreement Form instructs clients on the approved protocols and administration of the drug.
Clients sign that they have been informed about abortion pill risks, including:
heavy bleeding
infection
potential for fever, pain, or discomfort
and other signs of "a serious infection or another problem (including an ectopic pregnancy)," among other potential complications.

The "study" was funded by some abortion pill investors and included "the Susan Thompson Buffet Foundation, the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and Lucinda Watson," the authors wrote.
It was approved by the institutional review board (IRB) at the UC San Francisco (UCSF) and conducted from January to October of 2025 at select abortion facilities "where medication abortion/abortion is legal and in states/facilities where minors are able to consent for their own treatment for abortion care," claimed the IRB approval.
Study sponsor: University of California (UC), heavily funded by the Buffett Foundation.
Principal Investigator and co-author: Abortionist Daniel Grossman, who openly advocates abortion pills in "advance" of a pregnancy and is pushing over-the-counter dispensing. He previously suggested that emergency room doctors should avoid documenting abortion pill complications.
In the IRM, Grossman acknowledged the study had "not undergone scientific/peer review" and said "[s]tudy data are not publicly available."
When the IRB asked whether the study "may have risks to an embryo or fetus," authors responded "N/A" (not applicable) — yet abortion drugs intentionally target embryos and fetuses for death.

IRB asked, "Do you anticipate that this study may collect information that State or Federal law requires to be reported to other officials, such as elder abuse, child abuse, threat to self or others, or HIV status and other reportable conditions?"
Researchers responded "No," despite the fact that they recruited minors (under age 16) for their study, with no detail as to how they might rule out the possibility that a minor's pregnancy resulted from abuse or statutory rape, which is required to be reported.

The 593 participants (15 years or older) received a monetary gift card for participating. They were hand selected from three Planned Parenthood abortion facilities in Minnesota, Colorado, and California, as well as from Choices in Illinois, and Aria Medical in Kansas.
They were given the "mifepristone medication guide before being randomized into a study group" according to clinical trial methodology.
Randomized groups:
Control group: received PAF before survey (301)
Exposed group: received PAF after survey (292)
While "Participants and clinic staff were unaware of study group assignment prior to randomization" the clinical trial noted that "Following group assignment, masking was not maintained because the study design required participants in one group to be exposed to the intervention (receive, review, and sign the PAF) prior to completing the knowledge assessment."
In other words, clinic staff knew which clients were in each study group.
The results of this study were concerning.
The FDA-approved abortion pill regimen is made up of mifepristone (200mg)/Mifeprex as well as misoprostol.
Nearly 40% of all participants acknowledged they had a previous chemical abortion, indicating previous counseling and explanation of the patient agreement form.
Authors specified "both" of the study groups were "allowed to use any materials received during the visit, including the medication guide, while answering survey questions."
1) Administration
9% (8% in control/11% in exposed) did not understand which drug to take first.
23% did not comprehend how long they should wait before taking the second drug (misoprostol).
32% did not comprehend that misoprostol should to be taken buccally (in the cheeks of the mouth) versus vaginally.

2) Infection
Nearly 20% failed to understand that “Feeling sick with nausea, weakness, vomiting, or diarrhea for longer than 24 h... could be a sign of infection.”
14% did not comprehend they could "get an infection after taking medication abortion.”

3) Emergency Care
The study asked a series of questions regarding when to seek emergency care, and nearly 10% of participants answered incorrectly, revealing potential dangers for complications:

➡️ This is not proof that informed consent is "not useful" — it is proof that it IS necessary.
These clients were in-person when selected for this study and still 9-10% failed to fully understand the risks. Imagine what the number would be if this had been done by mail-order!
The authors even noted the difference, yet apparently decided that putting more women at risk by not properly informing them of the risks is acceptable:
[...]people exposed to the PAF were significantly more likely to know to contact a “health care provider” right away if they had a fever of 100.4 °F or higher than the control group.
4) Failure of Drug
Even more disturbing is that 83% thought that a continued pregnancy after taking the drugs was "rare" when the patient agreement was clear this can happen 2-7% of the time, and only half of the participants understood this fact.
This was among the questions identified as answered incorrectly "least often," the authors noted.
The potential consequences of this lack of knowledge are staggering.

In 2025, there were an estimated 734,435 abortion pill abortions.
21.3K to 44K potentially present to ERs annually after taking abortion pills.
15K to 51.4K abortions by pill likely fail each year, resulting in follow-up surgical procedures or additional drugs to complete the abortions.
Despite claiming the PAF is not useful, consenting for the study included a "Consent form and other study documents... in the participant’s primary language" and "dialogue, using open-ended questions about the nature of the study or the experimental treatment, the risks and benefits of participating, and the voluntary nature of participation."
How many (if any) women are going to get this kind of consent and discussion from mail-order abortion?
The authors noted that an "analysis of internal FDA documents" indicated "FDA scientists had recommended removal of the PAF," suggesting it was “duplicative of the informed consent and counseling processes.” But that decision was later overridden by the FDA commissioner.
Despite this, the authors concluded that the "FDA should consider removing the PAF requirement to streamline medication abortion provision" and determined that "some [PAF] requirements impose additional administrative burden without clear evidence of improving patient outcomes," adding — despite the concerning results of their own study — that the PAF "does not appear to be useful."
Pro-life medical malpractice attorney Mike Seibel disagreed with this assessment, telling Live Action News:
"This study shows that, after standard counseling at these facilities, patients already had high knowledge of medication abortion.
That high baseline knowledge is evidence that the current combination of in-person care and the required patient agreement form supports meaningful informed consent.
In clinical care, the goal is the highest practical level of informed consent to protect patient autonomy — not the minimum that can be shown on a quiz."
Study authors were associated with Advancing New Standards in Reproductive Health (ANSIRH), founded by an abortionist. ANSIRH is a program within UCSF’s Bixby Center for Global Reproductive Health, which trains abortionists.
The Journal of the American Medical Association (JAMA), is the publication of the pro-abortion American Medical Association (AMA). Letters from AMA and ACOG to the White House were credited with expanding access to the abortion pill under the Biden Administration. AMA opposes rolling back those expansions.
The study sampled 593 participants, yet over 700K abortion pills were prescribed last year alone and millions over the past decade. In addition, less than half a percent of the estimated 8,200 certified abortion pill prescribers (.0006) took part in the study.
Seibel warned that the "small sample drawn only from specialized facilities... does not justify removing existing safeguards":
"A study limited to three Planned Parenthood sites and two independent clinics with strong protocols does not tell us what happens at weaker clinics or in telehealth-only settings.
In my experience, many weaker clinics and telehealth-only models do not provide the same level of counseling. We should not weaken REMS safeguards based on data that exclude those models.
The form is not merely redundant paperwork; it functions as a structural safeguard that supports the counseling patients actually receive. We should not eliminate a mechanism that helps ensure high-quality informed consent."
"If the patient agreement form is driving providers to educate patients thoroughly, removing it is not streamlining care—it is removing a proven safeguard for informed consent," Seibel, who operates the website AbortionInjury.com, added. "Changes to the REMS or the patient agreement form should not be made on the basis of this study alone; broader research that includes weaker protocols and telehealth models is needed first."
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!

Bridget Sielicki
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Bridget Sielicki
·
Abortion Pill
Cassy Cooke
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill·By Carole Novielli
Big Abortion: Ensuring abortion pill clients are aware of risks is 'not useful'
The abortion industry ("Big Abortion") has long portrayed abortion as part of "healthcare" while simultaneously seeking to carve out special provisions so that abortion and its providers aren't subject to the same scrutiny or standards as the healthcare industry.
Now, it seems the industry isn't concerned that women are ill-informed of potential risks when they take the abortion pill, claiming that requiring them to sign an informative patient agreement form "does not appear to be useful" to Big Abortion's goal of "streamlin[ing]" the way it provides the abortion pill to purchasers.
A recent, non-peer-reviewed JAMA Internal Medicine "study" funded by abortion pill investors and donors claims that the FDA should remove a requirement for abortion pill clients to sign a Patient Agreement Form instructing them on the approved protocols and administration of the drug.
The form requires them to agree that they have been informed about abortion pill risks, including heavy bleeding; infection; potential for fever, pain, or discomfort; and other signs of "a serious infection or another problem (including an ectopic pregnancy)," among other potential complications.
The study of less than 600 participants (from less than half a percent of certified abortion pill prescribers) showed concerning results, especially given the fact that 40% of the women said they had taken the abortion pill before.
Nearly a fourth did not know how long to wait before taking the second drug in the abortion pill regimen, nearly a third didn't know how to properly take the second drug (in the cheeks of the mouth), one-fifth didn't know the possible signs of infection (with most not even knowing they could get an infection from the abortion pill), and 10% had no idea when to seek emergency care.
In addition, 83% thought an incomplete abortion is "rare" when it can be as high as 7%.
The results were also concerning because the study was in person and under strict protocol — which is very unlike real-world use.
Despite all of these results and more, the researchers claimed the form "does not appear to be useful" to "streamlining" provision of the abortion pill.
The proliferation of abortion pills under the Food and Drug Administration's (FDA) now-eroded safety protocols to allow for mail-order and pharmacy dispensing means the abortion industry profits by spending little to no time with abortion clients, doing no follow-up, offloading women to ERs when complications arise, and forcing women to dispose of their own dead children into the toilet (or even the household garbage if the body is too big to flush).
A recent, non-peer-reviewed JAMA Internal Medicine "study," titled "Mifepristone Patient Agreement Form and Medication Abortion Knowledge," was funded by original investors in the abortion pill, and urges the limiting of informed consent by removing the Patient Agreement Form (PAF) required under the FDA's REMS safety system.
The study proposes that the FDA should consider removing the mifepristone Patient Agreement Form (PAF) required for the abortion pill under the REMS safety system, because authors believe the form "does not appear to be useful" to their goal of "streamlin[ing] medication abortion provision."
The Patient Agreement Form instructs clients on the approved protocols and administration of the drug.
Clients sign that they have been informed about abortion pill risks, including:
heavy bleeding
infection
potential for fever, pain, or discomfort
and other signs of "a serious infection or another problem (including an ectopic pregnancy)," among other potential complications.

The "study" was funded by some abortion pill investors and included "the Susan Thompson Buffet Foundation, the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and Lucinda Watson," the authors wrote.
It was approved by the institutional review board (IRB) at the UC San Francisco (UCSF) and conducted from January to October of 2025 at select abortion facilities "where medication abortion/abortion is legal and in states/facilities where minors are able to consent for their own treatment for abortion care," claimed the IRB approval.
Study sponsor: University of California (UC), heavily funded by the Buffett Foundation.
Principal Investigator and co-author: Abortionist Daniel Grossman, who openly advocates abortion pills in "advance" of a pregnancy and is pushing over-the-counter dispensing. He previously suggested that emergency room doctors should avoid documenting abortion pill complications.
In the IRM, Grossman acknowledged the study had "not undergone scientific/peer review" and said "[s]tudy data are not publicly available."
When the IRB asked whether the study "may have risks to an embryo or fetus," authors responded "N/A" (not applicable) — yet abortion drugs intentionally target embryos and fetuses for death.

IRB asked, "Do you anticipate that this study may collect information that State or Federal law requires to be reported to other officials, such as elder abuse, child abuse, threat to self or others, or HIV status and other reportable conditions?"
Researchers responded "No," despite the fact that they recruited minors (under age 16) for their study, with no detail as to how they might rule out the possibility that a minor's pregnancy resulted from abuse or statutory rape, which is required to be reported.

The 593 participants (15 years or older) received a monetary gift card for participating. They were hand selected from three Planned Parenthood abortion facilities in Minnesota, Colorado, and California, as well as from Choices in Illinois, and Aria Medical in Kansas.
They were given the "mifepristone medication guide before being randomized into a study group" according to clinical trial methodology.
Randomized groups:
Control group: received PAF before survey (301)
Exposed group: received PAF after survey (292)
While "Participants and clinic staff were unaware of study group assignment prior to randomization" the clinical trial noted that "Following group assignment, masking was not maintained because the study design required participants in one group to be exposed to the intervention (receive, review, and sign the PAF) prior to completing the knowledge assessment."
In other words, clinic staff knew which clients were in each study group.
The results of this study were concerning.
The FDA-approved abortion pill regimen is made up of mifepristone (200mg)/Mifeprex as well as misoprostol.
Nearly 40% of all participants acknowledged they had a previous chemical abortion, indicating previous counseling and explanation of the patient agreement form.
Authors specified "both" of the study groups were "allowed to use any materials received during the visit, including the medication guide, while answering survey questions."
1) Administration
9% (8% in control/11% in exposed) did not understand which drug to take first.
23% did not comprehend how long they should wait before taking the second drug (misoprostol).
32% did not comprehend that misoprostol should to be taken buccally (in the cheeks of the mouth) versus vaginally.

2) Infection
Nearly 20% failed to understand that “Feeling sick with nausea, weakness, vomiting, or diarrhea for longer than 24 h... could be a sign of infection.”
14% did not comprehend they could "get an infection after taking medication abortion.”

3) Emergency Care
The study asked a series of questions regarding when to seek emergency care, and nearly 10% of participants answered incorrectly, revealing potential dangers for complications:

➡️ This is not proof that informed consent is "not useful" — it is proof that it IS necessary.
These clients were in-person when selected for this study and still 9-10% failed to fully understand the risks. Imagine what the number would be if this had been done by mail-order!
The authors even noted the difference, yet apparently decided that putting more women at risk by not properly informing them of the risks is acceptable:
[...]people exposed to the PAF were significantly more likely to know to contact a “health care provider” right away if they had a fever of 100.4 °F or higher than the control group.
4) Failure of Drug
Even more disturbing is that 83% thought that a continued pregnancy after taking the drugs was "rare" when the patient agreement was clear this can happen 2-7% of the time, and only half of the participants understood this fact.
This was among the questions identified as answered incorrectly "least often," the authors noted.
The potential consequences of this lack of knowledge are staggering.

In 2025, there were an estimated 734,435 abortion pill abortions.
21.3K to 44K potentially present to ERs annually after taking abortion pills.
15K to 51.4K abortions by pill likely fail each year, resulting in follow-up surgical procedures or additional drugs to complete the abortions.
Despite claiming the PAF is not useful, consenting for the study included a "Consent form and other study documents... in the participant’s primary language" and "dialogue, using open-ended questions about the nature of the study or the experimental treatment, the risks and benefits of participating, and the voluntary nature of participation."
How many (if any) women are going to get this kind of consent and discussion from mail-order abortion?
The authors noted that an "analysis of internal FDA documents" indicated "FDA scientists had recommended removal of the PAF," suggesting it was “duplicative of the informed consent and counseling processes.” But that decision was later overridden by the FDA commissioner.
Despite this, the authors concluded that the "FDA should consider removing the PAF requirement to streamline medication abortion provision" and determined that "some [PAF] requirements impose additional administrative burden without clear evidence of improving patient outcomes," adding — despite the concerning results of their own study — that the PAF "does not appear to be useful."
Pro-life medical malpractice attorney Mike Seibel disagreed with this assessment, telling Live Action News:
"This study shows that, after standard counseling at these facilities, patients already had high knowledge of medication abortion.
That high baseline knowledge is evidence that the current combination of in-person care and the required patient agreement form supports meaningful informed consent.
In clinical care, the goal is the highest practical level of informed consent to protect patient autonomy — not the minimum that can be shown on a quiz."
Study authors were associated with Advancing New Standards in Reproductive Health (ANSIRH), founded by an abortionist. ANSIRH is a program within UCSF’s Bixby Center for Global Reproductive Health, which trains abortionists.
The Journal of the American Medical Association (JAMA), is the publication of the pro-abortion American Medical Association (AMA). Letters from AMA and ACOG to the White House were credited with expanding access to the abortion pill under the Biden Administration. AMA opposes rolling back those expansions.
The study sampled 593 participants, yet over 700K abortion pills were prescribed last year alone and millions over the past decade. In addition, less than half a percent of the estimated 8,200 certified abortion pill prescribers (.0006) took part in the study.
Seibel warned that the "small sample drawn only from specialized facilities... does not justify removing existing safeguards":
"A study limited to three Planned Parenthood sites and two independent clinics with strong protocols does not tell us what happens at weaker clinics or in telehealth-only settings.
In my experience, many weaker clinics and telehealth-only models do not provide the same level of counseling. We should not weaken REMS safeguards based on data that exclude those models.
The form is not merely redundant paperwork; it functions as a structural safeguard that supports the counseling patients actually receive. We should not eliminate a mechanism that helps ensure high-quality informed consent."
"If the patient agreement form is driving providers to educate patients thoroughly, removing it is not streamlining care—it is removing a proven safeguard for informed consent," Seibel, who operates the website AbortionInjury.com, added. "Changes to the REMS or the patient agreement form should not be made on the basis of this study alone; broader research that includes weaker protocols and telehealth models is needed first."
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!

Bridget Sielicki
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Bridget Sielicki
·
Abortion Pill
Cassy Cooke
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Carole Novielli
·