FIRST ON THE DAILY SIGNAL—Three Republican senators are asking Attorney General Pam Bondi to investigate whether drug manufacturers misrepresented the abortion pill’s safety and efficacy.
“We write to you regarding a serious public health failure that endangers countless American women,” a letter obtained by The Daily Signal reads. “In light of new data, we request an investigation into whether drug manufacturers have misrepresented mifepristone’s safety and efficacy—placing hundreds of thousands of women at risk.”
Republican Sens. Steve Daines of Montana, Marsha Blackburn of Tennessee, and Jim Banks of Indiana sent a letter to Bondi on Tuesday requesting a probe into potential criminal and civil misconduct of chemical abortion drug manufacturers.
July 24, 2025
The Honorable Pamela Bondi
Attorney General
U.S. Department of Justice
950 Pennsylvania Avenue, NW
Washington, DC 20530-0001
Dear Attorney General Bondi:
We write to you regarding a serious public-health failure that endangers countless American
women. In light of new data, we request an investigation into whether drug manufacturers have
misrepresented mifepristone’s safety and efficacy—placing hundreds of thousands of women at
risk.
The Ethics and Public Policy Center (“EPPC”) recently completed the largest study ever
performed on chemical abortion, focusing on mifepristone.[1] Mifepristone was first approved by
the FDA in 2000 based on sparse clinical trials of only 859 U.S. participants.[2] The evidence
shows that the current drug label is based on trials of fewer than 31,000 participants.[3] But EPPC
has now analyzed insurance claims data from over 865,000 mifepristone abortions billed to
public and private payors, along with the serious adverse events related to actual use of
mifepristone between 2017 and 2023. Based on that real-world analysis, it has become clear that
women who take mifepristone suffer serious adverse events at levels 22 times greater than what
is represented on the FDA-approved (19-page) drug label.[4]
Chemical abortions are more prevalent than ever in the post-Dobbs era. Roughly 2/3 of abortions
today are chemical abortions.[5] These abortions are administered through a combination of
mifepristone and misoprostol.[6] A person’s opinion about abortion is irrelevant. This is a
women’s health and safety issue.
Upon initial FDA approval in 2000, modest and commonsense safeguards known as Risk
Evaluation and Mitigation Strategies (REMS) were required for chemically induced
abortions. For example:
- A woman would have to make at least three in-person doctor visits.
- Mifepristone could be prescribed only by a physician.
[1] Jamie Bryan Hall, Ryan T. Anderson, Ethics and Public Policy Center, The Abortion Pill Harms Women: Insurance Data
Reveals One in Ten Patients Experiences a Serious Adverse Event 1 (April 28, 2025) (hereafter One in Ten Patients).
[2] Stop Harming Women, FDA Regulation of Mifepristone: Timeline of Changes (2000–2023) (April 27, 2025),
https://perma.cc/Q8P7-JVEY (hereafter FDA History).
[3] One in Ten Patients, supra note 1, at 4.
[4] Id. at 1.
[5] Guttmacher Institute, Medication Abortions Accounted for 63% of All US Abortions in 2023, an Increase from 53% in 2020
(March 19, 2024), https://perma.cc/JWQ4-F9H2 (hereafter 63% of Abortions).
[6] One in Ten Patients, supra note 1, at 4. - The drug could be administered only in a clinic, medical office, or hospital, under doctor
supervision. - Adverse events were required to be reported.[7]
But in 2016 and 2023, the FDA under Presidents Obama and Biden whittled these already
meager safeguards down to almost nothing.[8] Whereas the original approval permitted
administering mifepristone up to the seventh week of pregnancy, the drugs may now be
administered at a gestational age of 10 weeks (with no requirement for verification through a
physical exam).[9] Further, a mifepristone abortion requires only a single telehealth visit.[10] No
exam is required to rule out an ectopic pregnancy.[11] And it need not even be guided by a
physician; any “approved healthcare provider” suffices.[12] A patient may receive the drugs
through the mail and self-administer them. And, shockingly, under the revised REMs, the
prescriber does not even need to report an adverse event unless the woman dies.[13]
Loosened requirements might have made sense for a noninvasive drug. But, as it happens, these
lax requirements only simplified access to a drug that quite often causes great harm to the
mother, as the latest data shows.
The real risk of serious adverse events to American women is also unconscionably downplayed
on the label, which reports an adverse-effect rate of just 0.5%.[14] The label is appallingly wrong.
Between 2017 and 2023, women were administered over 865,000 mifepristone abortions that
were charged to a public or private payor. Of those, almost a full 5% of women—nearly
41,000—required serious to severe level emergency room (ER) visits related to mifepristone.
Over 28,000 experienced hemorrhaging. More than 11,000 reported infection. At least 824
women had life-threatening sepsis. And well over 24,000 went on to need surgery to complete
what the pill could not.[15] All told, a full 10.93% of patients—more than one out of every ten
women—endured some kind of serious adverse event after taking mifepristone.[16] In other
words, women suffer from complications at a rate about 22 times higher than the drastically
underreported 0.5% rate conveyed by the label.[17]
For every woman that the mifepristone label admits it could potentially harm, over 20 additional
women suffer serious adverse events. Quite frankly, this is outrageous. And the American people
deserve better.
The above data does not even include mifepristone failure rates. Outdated clinical trials suggest
that between 2.6% and 3.8% of the time a woman takes mifepristone, it fails to result in an
[7] Id. at 3.
[8] Id.; FDA History, supra note 2.
[9] One in Ten Patients, supra note 1, at 3.
[10] Id.
[11] See id. at 2–3.
[12] Id. at 3.
[13] Id.
[14] Id. at 1.
[15] Stop Harming Women, Harms to Women From Mifepristone Abortion (April 26, 2025), https://perma.cc/6VK2-VKUH
(hereafter Serious Adverse Effects).
[16] Id.; Jamie Bryan Hall, Ryan T. Anderson, Ethics and Public Policy Center, Frequently Asked Questions About the Largest
Study on Chemical Abortion 1 (May 7, 2025) (hereafter FAQs).
[17] Serious Adverse Effects, supra note 15; One in Ten Patients, supra note 1, at 1; FAQs, supra note 16, at 1.
abortion.[18] But the real-world healthcare-claims data shows that the number is actually higher.
The reason: on 45,498 occasions, women whose chemical abortions failed either pursued a
second chemical abortion or a surgical abortion. Thus, a whopping 5.26% of women who
charged a mifepristone script to insurance, or one of every 19, sought additional abortions after
their attempts to terminate their pregnancies after mifepristone failed.[19] All told, over 13.5% of
women—nearly one in seven—either suffer serious adverse events or require subsequent
chemical or surgical abortion attempts after taking mifepristone.[20]
Equally alarming, the numbers above represent only about one-quarter of the women
experiencing such serious events. Consider the numbers from 2023. As the Guttmacher Institute,
which has long-standing ties to Planned Parenthood, details, out of the 1,037,000 abortions that
took place in 2023,[21] more than 60% of those—approximately 642,700—were medication
abortions.[22] But the amount of medication abortions that appear in the data for 2023 is
154,554—or about 24% of the total number of chemical abortions in 2023. The remaining 76%
are cash pay abortions. That means that all the numbers above regarding the number of women
suffering serious ER visits, hemorrhaging, infections, etc., should be increased by a factor of
four.
The EPPC’s recent study has several advantages over the small and outdated clinical trials on
which mifepristone’s drug label is based. First, the scope of the study is far more robust than the
clinical trials. The current FDA-approved drug label is based on clinical trials involving 30,966
healthy participants under supervised conditions.[23] The recent real-world study dwarfs that
sample size with a dataset comprising 865,727 prescribed mifepristone abortions. Second, this
study is more recent. FDA’s approval of mifepristone is based on data more than a decade old.[24]
The EPPC’s study, however, draws from data collected between 2017 and 2023.[25] As such, in
addition to being more recent, the EPPC’s study captures the time period after the FDA began
loosening safety regulations and waiving reporting requirements. Third, this study provides a
snapshot of the real-life medical experience of actual American women, as opposed to tightly
controlled clinical trials amongst only healthy women administered by physicians and sponsored
by pharmaceutical companies.[26] Fourth, unlike the original trials, this data is safeguarded from
outcome-bias. All of these reasons make the recent report more reliable than any other study of
mifepristone ever performed.
There is a fifth advantage that the EPPC’s study has over the current basis for the FDA’s
mifepristone label, and it is relevant for what follows in this letter: the study is designed to be
replicable by anyone.[27] It is objective, repeatable, verifiable, and thus actionable.
[18] Jamie Bryan Hall, Ryan T. Anderson, Ethics and Public Policy Center, The Abortion Pill Harms Women: Insurance Data
Reveals Repeated Abortion Attempts Due to High Failure Rate 1 (May 12, 2025) (hereafter High Failure Rate).
[19] Id. at 2.
[20] Id.
[21] Guttmacher Institute, Despite Bans, Number of Abortions in the United States Increased in 2023 (March 19, 2024),
https://perma.cc/QC5L-Q7RF.
[22] 63% of Abortions, supra note 5.
[23] One in Ten Patients, supra note 1, at 4.
[24] Id. at 2.
[25] Id. at 2, 4.
[26] Id. at 2.
[27] FAQs, supra note 16, at 3–4.
If it were any other issue, Democrats would be up in arms. But this issue relates to abortion, so
the Democrats will do nothing. You, however, can. A key question is whether appropriate
procedures were followed when safety regulations were lifted in 2016 and again in 2023. It is
unclear what processes, if any, the FDA under Presidents Obama and Biden followed when
loosening—and then waiving—the safety regulations originally put in place to protect women. It
is also unclear if the FDA worked with the manufacturer of Mifeprex, Danco Laboratories, in
considering new data, new clinical trials, or real-world market analysis that justified doing away
with safety standards. What is clear is that not a single study cited publicly by the Obama or
Biden FDA actually supported loosening mifepristone’s safety regulations. This suggests blatant
negligence by the Biden FDA at best and potentially politically motivated machinations within
the Biden Administration to pressure FDA to loosen their safety standards to satisfy their
pharmaceutical industry and political allies. The Biden FDA made additional moves to loosen
regulations soon after the U.S. Supreme Court’s Dobbs decision allowing abortion restrictions by
the states, emasculating that ruling by changing regulations to allow one provider in one state to
provide chemical abortions in all fifty states, regardless of their laws. The thousands of women
being harmed by these moves are just unrecognized collateral damage.
In our experience, health insurance companies do not pay for procedures that were not done, so
this recently released EPPC study showing real world data raises very concerning questions not
only about the Biden FDA, but also about the actions of the chemical abortion manufacturers,
including Danco Laboratories and GenBioPro. As you know, the Federal Food Drug and
Cosmetic Act clearly states that knowingly providing false statements about a drug’s
effectiveness or safety, or failing to report a drug’s adverse side effects, could constitute criminal
or civil violations. Yet the EPPC healthcare claims data shows these high levels of serious
adverse events over a 7-year period starting in January, 2017, well before and indeed during the
Biden FDA loosening of the safety standards and reporting requirements on mifepristone. What
did these manufacturers know and when did they know it? What did they report or say to the
FDA and when? It is telling that even since the EPPC health care claims data has been released
showing safety and efficacy failure rates at much higher levels than the FDA claims on the
mifepristone label, a Danco spokesperson has asserted their previous “safe and effective”
claims[28] while their business partners, including Planned Parenthood, assert the ludicrous lie to
American women that “mifepristone is as safe as Tylenol.”[29] This is unconscionable and must
not be allowed to continue.
The waiver of the reporting requirements also needs to be investigated. American families rely
upon the FDA to protect them from harmful drugs and are, at the very least, entitled to know the
real risks of the drugs they take. There is no reason the FDA should waive reporting
requirements when serious adverse events occur. Such conduct keeps our citizens in the dark and
actively works against their being able to provide informed consent. And it is especially perilous
when such waivers are issued in parallel with loosening the safety standards.
[28] Fox News, July 8th, 2025: https://www.foxnews.com/politics/medical-groups-urge-kennedy-fda-reexamine-broad-approval
abortion-drugs
[29] Planned Parenthood: “Medication abortion is safer than other common medicines like penicillin, Tylenol, and
Viagra.” What You Need to Know About the Latest Attack on Abortion Care: the Mifepristone Abortion Pill
The FDA is responsible for ensuring safety, efficacy, and transparency around the drugs
Americans take. By failing to hold to these standards, the FDA has permitted mifepristone to
harm hundreds of thousands of women over the last decade. There is no reason to believe the
dangers will stop without action. The extent of the harm has not been clear until now. And
hundreds of thousands of women are at risk of serious harm to their bodies by the FDA’s
continued recklessness around this drug.
This is an urgent matter of public safety. Hundreds of women are being harmed every day. We
encourage the Department of Justice to initiate a federal investigation into the potential criminal
and civil misconduct of chemical abortion manufacturers. Given the breadth of the data and the
implications for public health, we respectfully urge swift action to determine whether federal law
was violated that compromised the safety of American women. Thank you for your continued
work to uphold federal law, protect women’s health, and ensure that government agencies and
pharmaceutical companies are held accountable to the American people.
Sincerely,
Steve Daines
United States Senator
Marsha Blackburn
United States Senator
Jim Banks
United States Senator
“A person’s opinion about abortion is irrelevant,” the pro-life senators wrote. “This is a women’s health and safety issue.”
The senators urged the Justice Department to act now to protect women.
“We encourage the Department of Justice to initiate a federal investigation into the potential criminal and civil misconduct of chemical abortion manufacturers,” Daines said. “Given the breadth of the data and the implications for public health, we respectfully urge swift action to determine whether federal law was violated that compromised the safety of American women.”
Safety regulations on mifepristone were lifted in 2016 and again in 2023. The senators say the Justice Department needs to investigate what processes, if any, were followed when the safeguards on the pills were loosened.
It’s unclear whether the FDA worked with the manufacturer of Mifeprex, Danco Laboratories, in considering new data, new clinical trials, or real-world market analyses that justified reducing safety standards, the letter says.
President Donald Trump’s DOJ also needs to investigate the lack of reporting requirements on abortion pill injuries, the senators said.
“American families rely upon the FDA to protect them from harmful drugs and are, at the very least, entitled to know the real risks of the drugs they take,” the letter says. “There is no reason the FDA should waive reporting requirements when serious adverse events occur.”
“Such conduct keeps our citizens in the dark and actively works against their being able to provide informed consent,” the senators added.
If this were any other issue, Democrats would be up in arms, the trio of lawmakers wrote.
“But this issue relates to abortion, so the Democrats will do nothing. You, however, can,” they wrote to Bondi.
Elizabeth Troutman Mitchell@TheElizMitchell
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