FDA Will Reportedly Conclude Abortion Pill Safety Review by September
The U.S. Food and Drug Administration (FDA) is expected to conclude a safety review of the abortion pill by September, according to recent reports.
Weeks ago, the FDA commenced a study of the safety of mifepristone – the first drug in the two-drug abortion regimen commonly referred to as the “abortion pill.”
Should the FDA conclude the abortion pill is unsafe, it could modify the drug’s REMS (Risk Evaluation and Mitigation Strategies), a regulation the FDA places on drugs it considers riskier than typical medications, and reinstitute safety guardrails that had been in place for decades.
In 2023, the Biden FDA modified mifepristone’s REMS by removing the in-person dispensing requirement, making mifepristone available thorough telehealth appointments, obtainable by mail nationwide, and available at retail pharmacies.
These changes essentially made every mailbox and bathroom an abortion clinic, since women could obtain mifepristone by mail without ever talking to a physician in person. These modifications made it far easier to access mifepristone, despite its numerous safety concerns.
In April 2025, the Ethics and Public Policy Center (EPPC) released a study finding that nearly 11% of all women who abort their children with mifepristone suffer from life-threatening conditions including sepsis, infection or hemorrhaging.
The Biden FDA’s changes to the REMS requirements also made it far easier for men to abuse women with the abortion pill.
This happened to Rosalie Markezich, who was forced by her violent boyfriend to take the abortion drugs after he obtained them online from a doctor in California and had them mailed to her home in Louisiana. “I was scared, and I felt pressured to take the pills. So I did,” she later shared.
Pro-life supporters were hopeful that the Trump administration, committed to “Making America Healthy Again,” would crack down on the dangerous drug and protect women from its serious and life-threatening side effects.
However, pro-life supporters became increasingly frustrated with FDA Commissioner Marty Makary for allegedly slow-walking a review of the abortion pill for months. Makary stepped down from the role in May 2025 and was replaced by Kyle Diamantas, who now serves as acting FDA commissioner.
Shortly after being appointed, Diamantas reached out to leaders in the pro-life movement and promised action on the abortion pill. Days later, the FDA revealed its was reevaluating mifepristone’s safety profile.
“The Trump Administration is pursuing a rigorous review of mifepristone in response to widespread safety concerns, adhering to the highest scientific standards,” White House spokeswoman Allison Schuster recently told the Daily Signal.
“This Gold Standard Science-based safety review led by the FDA, which remains ongoing, is just one example of President Trump’s total commitment to thoroughly evaluating emerging drugs to ensure the health and safety of all Americans.”
Let’s hope, pray and call upon the FDA to act soon to protect women from the abortion pill.
If you are experiencing an unexpected pregnancy and want to learn more about your options, you can visit My Choice Network.
If you’re struggling and need a listening ear, Focus on the Family offers a free, one-time counseling consultation with our ministry’s professionally trained counseling staff. To request a counseling consultation, call 1-855-771-HELP (4357) or fill out our Counseling Consultation Request Form.
Related articles and resources:
Dealing With Unplanned Pregnancy
Become an Option Ultrasound Life Advocate
New Insights on the Dangers of the Abortion Pill
Overcoming Abortion and Becoming a Force for Life
What Does the FDA Shakeup Mean for Abortion Pill Review?
Photo from Getty Images.
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