Ethics and Public Policy Center Releases Largest-Ever Study of Chemical Abortion Pill
New Study Reveals Shocking Serious Adverse Event Rate 22% Times Higher than the FDA-Approved Drug Label Reports
Last month, on April 28, the Ethics and Public Policy Center (EPPC), a Washington, D.C. based think-tank, released findings from the most comprehensive ever study of the chemical abortion pill mifepristone. (See EPPC Study Paper HERE)
Mifepristone is the first pill that women take in the deadly two-pill regimen to complete a chemical abortion.
The graph below demonstrates the rapid rate at which chemical abortions have increased since the U.S. Food and Drug Administration (FDA) approved mifepristone in 2000 and now account for at least two-thirds of the abortions in the United States. Dr. Christina Francis, CEO of the American Association of Pro-Life Obstetricians and Gynecologists, and other experts believe that current chemical abortion numbers are actually closer to 80% of abortions. (See Council for Life News HERE)
Obviously, the unborn baby tragically dies from a chemical abortion. It is equally imperative that we understand the profound risks and harm to women from chemical abortions, and specifically from mifepristone.
During the Obama and Biden administrations, the FDA significantly weakened common sense safety regulations originally intended to protect women using mifepristone with the goal to expand abortion access. (See Council for Life News HERE, HERE, HERE, HERE and HERE)
As reflected in the chart below, under the current FDA Risk Evaluation and Mitigation Strategy (REMS) in effect since 2023, a woman can:
- Obtain mifepristone through the mail with a telehealth visit from any healthcare provider (not necessarily a physician).
- Self-administer the drug.
The prescriber has no requirement to report any adverse events unless the patient dies.
Source: Ethics and Public Policy Center Paper dated April 28, 2025
Key Findings
The EPPC’s “The Abortion Pill Harms Women” Study reveals the egregious impact of the FDA’s reckless policy decision on the health of hundreds of thousands of women.
The EPPC Study is based on analysis of 865,727 mifepristone abortions that occurred between 2017 to 2023 which is (i) 28 times more mifepristone abortions included than in all FDA clinical trials combined and (ii) significantly more current data than the over a decade old data relied upon by the FDA.
Key Findings reveal:
- Over one in ten women experience sepsis, infection, hemorrhaging, or another Serious Adverse Event following a mifepristone abortion.
- The Serious Adverse Event rate from mifepristone is 22 times more frequent than the FDA approved drug label currently reports of “less than 0.5 percent”.
Mifepristone Policy Conclusions
The Study concluded that the FDA should reconsider its approval of mifepristone and, at a minimum, “immediately reinstate” the patient safety protocols that were originally required by the FDA when mifepristone was first approved in 2000, including:
- At least three in-person office visits by the patient.
- Prescribed only by physicians to a woman who is confirmed by a physician to be in the first seven weeks of pregnancy.
- Administered only in a clinic, medical office or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.
Require healthcare providers to report all serious adverse events to the FDA and manufacturers of mifepristone.
Strong Response to EPPC Findings
U.S. Senator Josh Hawley Sends Letter to FDA Commissioner and Introduces Legislation to Reinstate Safety Regulations on Mifepristone
Johns Hopkins University Health Care Expert and new FDA Commissioner Dr. Marty Makary
On April 28, the day the EPPC Study was released, U.S. Senator Josh Hawley (R-Missouri) sent a letter to FDA Commissioner Dr. Marty Makary, directing his attention to the EPPC’s findings and urging action to reinstate the critical mifepristone safeguards. (See Senator Hawley Letter to Dr. Makary HERE)
Missouri Senator Josh Hawley introduces legislation to implement safeguards for abortion pill mifepristone. (Reuters/Getty)
On May 5, Senator Hawley wrote a scathing Op-Ed piece and the next day introduced the Restoring Safeguards for Dangerous Abortion Drugs Act. The Act would reinstate safety regulations on mifepristone, allow women who have been harmed by the drug to sue telehealth providers and others that illegally mail the drug and ban foreign companies from mailing and importing mifepristone into the U.S. (See The Federalist Senator Hawley Op-Ed HERE and the full text of the Act HERE)
HHS Secretary Robert Kennedy Orders FDA Complete Review of Abortion Pill
On May 14, in response to the EPPC findings, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. ordered a top-down review of the abortion drug mifepristone.
The latest research is “alarming” Kennedy said during a hearing before the Senate Health, Education, Labor and Pensions Committee. “And clearly it indicates at the very least the [FDA] label should be changed.”
“I’ve asked Marty Makary, who’s the director of the FDA, to do a complete review and to report back,” Kennedy added. (See Hearing and HHS Secretary Kennedy at Time Stamp 01:48:10 to 01:50:40 HERE)
Pro-Life Coalition Letter to HHS Secretary Kennedy and FDA Commissioner Makary Urges Action
A letter dated May 14 addressed to HHS Secretary Kennedy and FDA Commissioner Makary citing the EPPC data was sent by a coalition of over 100 pro-life organizations and leaders. The letter expressed gratitude for efforts to protect American health and urged action to address the risks associated with mifepristone. (See Pro-Life Coalition Letter HERE)
Abortion Advocates Attempt to Debunk EPPC Study
Abortion advocates were quick to question the EPPC Study, labeling it as “biased” and “lacking scientific rigor”. (See Washington Post article HERE)
The American College of Obstetricians and Gynecologists (ACOG) and other “independent reproductive health experts” claim chemical or “medical” abortion has a proven safety record. In an April 30 email, Stella Dantas, President of ACOG, said the EPPC Paper is “seriously flawed” and “manipulates data to drive a myth that medication abortion isn’t safe.” (See Agence France Press Fact Check HERE)
Abortion Numbers are Increasing Post-Roe Due to Chemical Abortion Pills
Texas is Leading the Charge to Stop the Illegal Trafficking of the Pills Into the our State
Although we praise God for the overturn of Roe and abortion ban laws in Texas and other states, our hearts break that abortion numbers are increasing because of the expanded access to dangerous chemical abortion pills.
In a piece published last month in Washington Monthly, Dr. Carrie N. Baker, Bauman Professor of American Studies and Chair of the Study of Women, Gender and Sexuality at Smith College, boasts how in a post-Roe world “reproductive freedom advocates outsmarted” the pro-life movement because of the abortion pill.
Dr. Baker attributes increased abortion access, even in states with abortion bans, to the advent of telehealth abortion, the development of community support networks that provide free abortion pills and overseas providers. She points out that states such as California and New York where abortion is legal have telehealth provider shield laws allowing the provision of pills anywhere in the U.S. (See Washington Monthly HERE)
Texas is the first state to target the abortion industry’s new lethal tactic to evade our strong abortion ban. The Women and Child Protection Act is a comprehensive, groundbreaking bill filed in the current Texas Legislative session to stop the illegal trafficking of dangerous chemical abortion pills into our state. (See Council for Life News HERE)
Texas lawmakers conclude their current session on June 2. The Women and Child Protection Act has been passed by the Texas Senate and is set for a vote on the House floor as soon as today.
Please Pray
Please join us in praying for all government leaders to use their positions of power to cherish and protect vulnerable mothers and their unborn babies.
GIVE FOR LIFE & DOUBLE THE IMPACT WITH MATCHING GRANT
Your donation will FUND our 34 outstanding 2025 Beneficiaries and your IMPACT DOUBLED thanks to a generous $225,000 matching grant from: The Lunsford Foundation, the Lupe Murchison Foundation and an Anonymous Donor.