The U.S. Department of Health and Human Services (HHS) confirmed in a recent letter it has launched an investigation into the abortion drug mifepristone and its negative impact on women’s health.
The Abortion Pill
Mifepristone is responsible for the deaths of roughly 7.5 million preborn children since it was first approved by HHS in 2000.
The abortion pill, now the most common method of abortion in the United States, is a two-drug regimen administered to kill a woman’s preborn child. The first drug, mifepristone, blocks the essential pregnancy hormone progesterone, cutting off blood supply and nutrients to the preborn baby. The second drug, misoprostol, causes the woman to go into labor and expel her now dead child.
Earlier this year, Focus on the Family aired an interview with Dr. Bill Lile and Robyn Chambers, Vice President of Advocacy for Children at Focus on the Family, on the dangers the abortion pill poses to women.
You can watch the episode of Focus on the Family with Jim Daly below:
The REMS Requirements
In 2000, when the U.S. Food and Drug Administration (FDA) first approved mifepristone, it placed a Risk Evaluation and Mitigation Strategy (REMS) designation on the drug. The FDA reserves this designation for only the most dangerous drugs.
As a part of the REMS designation, the agency instituted an “in-person dispensing requirement,” requiring mifepristone be dispensed and administered only in a clinic, medical office or hospital. It also allowed the drug to be administered only in the first seven weeks of pregnancy.
In 2016, the Obama FDA allowed the drug to be administered out-of-office and permitted mifepristone to be taken in the first 10 weeks of pregnancy.
In 2021, in its push to promote abortion at all cost, the Biden administration’s FDA ended the in-person dispensing requirement, allowing the drug to be obtained through the mail rather than from a licensed physician in an office setting. The FDA made this determination permanent in 2023.
In 2021, the department also added a new pharmacy certification process, permitting retail pharmacies – like Walgreens and CVS – to sell the drug.
Photo Credit: Ethics and Public Policy Center
The relaxing of the REMS requirements on mifepristone made the dangerous drug more available, more easily accessible, and therefore, more likely to harm women.
The Study
Earlier this year, the Ethics and Public Policy Center released an important study analyzing 865,727 prescribed mifepristone abortions from 2017 to 2023.
It found that almost 11 % of women experience sepsis, infection, hemorrhaging, or another serious adverse event following a mifepristone abortion. Women were 22 times more likely to be harmed from mifepristone than the FDA had previously acknowledged, the study found.
The Request & Reply
In July, 22 state attorneys general asked HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to reinstate safety guardrails on the abortion drug the Biden administration had terminated.
On September 19, 2025, Secretary Kennedy and Commissioner Makary replied to the attorneys general, revealing HHS is investigating the drug.
“Since its original approval, the FDA has received reports of serious adverse events in patients who took mifepristone,” Kennedy and Makary acknowledged. “As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary actions.”
The letter cited the EPPC study, recognizing it indicated “potential dangers that may attend offering mifepristone without sufficient medical support or supervision.”
“The FDA’s own data collected between 2000 to 2012 indicated 2,740 adverse events, including 416 events involving blood loss requiring transfusions,” the letter disclosed. “Since then, safeguards for women regarding the administration of mifepristone have been significantly reduced.”
The letter continued,
The concerns you have raised in your letter merit close examination. This Administration will ensure that women’s health is properly protected by thoroughly investing the circumstances under which mifepristone can be safely dispensed.
The Response
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser issued a statement after the announcement, saying, “We’re encouraged that the Trump administration is conducting this study and taking women’s real experiences seriously.”
She added,
Behind the mounting scientific evidence are real tragedies – women and girls suffering life-threatening complications, mothers coerced and poisoned, and even some dying alongside their babies.
At the very least, basic safety protocols must be reinstated, and abortion drugs must be taken out of the mail while these studies are underway.
“Biden’s FDA exploited COVID-19 to gut safeguards, greenlighting mail-order abortion drugs with no in-person exam, medical oversight or even confirmation that the drugs are being ordered by the woman herself rather than an abuser or trafficker,” Dannenfelser continued.
“Biden’s recklessness must be stopped now.”
What’s Next?
The FDA’s review of mifepristone will likely determine that mifepristone causes serious harm to a large percent of women who take it.
Hopefully, the FDA will subsequently reinstate the REMS requirements for mifepristone to help protect women from the dangers involved in aborting their preborn children.
At Focus on the Family, we have been working to turn the cultural tide and save mothers and babies from abortion for years. Since beginning the Option Ultrasound Program in 2004, Focus has helped save over half a million lives. Just $60 will help save a life through Option Ultrasound. Will you partner with us to save lives from abortion?
If you are experiencing an unexpected pregnancy and want to learn more about your options, you can visit My Choice Network.
Related articles and resources:
Counseling Consultation & Referrals
Dealing With Unplanned Pregnancy
The Abortion Pill: How Does It Work?
Become an Option Ultrasound Life Advocate
Making America healthy again requires restricting access to this drug
Senators Ask AG Bondi to Investigate Abortion Pill Manufacturers
RFK Jr. Announces ‘Complete Review’ of Abortion Pill After ‘Alarming’ New Study Reveals Dangers
New Abortion Pill Study Confirms Danger to Mothers
Photo from Getty Images.
