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PJI-CPP Successfully Urges FDA to Review Abortion Pill Authorization Following Alarming Study

FDA now reviewing mifepristone regulations, as urged in PJI-CPP’s formal letter

May 22, 2025

Pacific Justice Institute – Center for Public Policy (PJI-CPP) is renewing its urgent call for the U.S. Food and Drug Administration (FDA) to revoke or suspend approval of mifepristone—the abortion pill—after a new, in-depth study revealed shocking rates of serious complications among women who take the drug. The FDA has now confirmed it will begin reviewing regulations surrounding mifepristone, a step PJI-CPP strongly advocated for in its recent letter to the agency.

The study, released earlier this week by the Ethics and Public Policy Center (EPPC), analyzed 865,727 insurance claims from 2017 to 2023. It found that 10.93% of women who took mifepristone experienced serious adverse events within 45 days—an alarming rate more than 22 times higher than the <0.5% risk cited on the drug’s label.

Key findings from the April 28, 2025 EPPC study include:
* 4.7% of women required emergency room care after the abortion
* 3.3% suffered hemorrhaging
* 1.3% developed infections
* Over 1,000 required blood transfusions
* Nearly 2,000 experienced other life-threatening adverse events
* 2.84% required surgical intervention for incomplete abortions

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“EPPC’s groundbreaking study—by far the most comprehensive to date—exposes a serious public health crisis the FDA can no longer afford to ignore,” said Brad Dacus, president and founder of PJI. “We are encouraged to see the FDA now reviewing mifepristone regulations, but reviewing alone is not enough. This drug’s approval must be reconsidered to protect women’s lives.”

In its formal letter to Commissioner of Food and Drugs Martin A. Makary, M.D., M.P.H., PJI-CPP highlighted his previous commitment to reassessing mifepristone’s availability if new safety data emerged. The letter also noted that Secretary of Health and Human Services Robert F. Kennedy Jr. pledged during his Senate confirmation hearing to investigate concerns about the drug’s safety.

PJI-CPP is calling for the FDA to immediately:
* Revoke or suspend mifepristone’s approval pending a full safety review
* Reinstate original REMS protocols including in-person dispensing, physician-only prescribing, three office visits, and mandatory adverse event reporting
* Launch an independent investigation into mifepristone’s real-world safety using current, large-scale data

“The FDA has a legal and moral obligation to act in light of this overwhelming evidence,” said David Peters, an attorney and medical doctor with PJI. “Women’s health is at stake.”

PJI-CPP is urging citizens nationwide to contact the FDA and their federal representatives, demand action, and help raise awareness about the devastating consequences this drug poses.

Media Inquiries: Please contact [email protected]

About Pacific Justice Institute
Pacific Justice Institute is a non-profit 501(c)(3) legal defense organization committed to defending religious freedom, parental rights, and other civil liberties.
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