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 the U.S. Food and Drug Administration (FDA) 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.

The REMS Requirements

In 2000, when the 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.

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 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.”

The FDA’s review of mifepristone will likely determine that mifepristone causes serious harm to a large percentage 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.

Daily Citizen is a news division of Focus on the Family that provides a faith-based perspective to counter the mainstream media’s anti-Christian bias.