Pro-life organization calls on HHS and FDA to suspend abortion pill approval, tighten safety rules

FIRST ON FOX: Live Action, a pro-life organization, is demanding that the Trump administration take action on the distribution of and reporting on mifepristone, often colloquially called "the abortion pill." 

The group is holding a press conference on Capitol Hill on Thursday to discuss concerns surrounding the abortion drug, as well as a new investigative video from Live Action that the group says documents "the dangerous real-world distribution of this drug by Planned Parenthood and affiliated providers." The group alleges "reckless distribution" practices and argues the adverse effects of the drug are not being documented properly, if at all.

In a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary, Live Action said it aims to show "clear evidence of regulatory noncompliance and patient harm" and to issue a call for immediate action from HHS and the FDA.

The letter urges HHS and the FDA to suspend the approval of mifepristone, prohibit the distribution of abortion pills through mail-order services and telehealth, reinstate comprehensive adverse-event reporting requirements, and release a full public accounting of the scientific and clinical evidence used to expand access to the drug.

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"For more than two decades, mifepristone has remained on the market under an approval process that was politically accelerated, shielded from transparency, and repeatedly expanded without regard for patient safety, adverse event reporting, or statutory compliance," the letter, signed by Lila Rose, Live Action founder and president, reads.

The FDA currently allows mifepristone to be prescribed via telehealth appointments and distributed by mail under its risk evaluation and mitigation strategy (REMS) program. The FDA advises against buying mifepristone online outside its REMS program, warning that those who do "would be bypassing important safeguards specifically designed to protect their health."

"As previously stated, HHS is conducting a study of reported adverse events associated with mifepristone to assess whether the FDA's risk mitigation program continues to provide appropriate protections for women," HHS press secretary Emily Hilliard told Fox News Digital.

"The FDA's scientific review process is thorough and takes the time necessary to ensure decisions are grounded in gold-standard science. Dr. Makary is upholding that standard as part of the Department's commitment to rigorous, evidence-based review," she added.

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The letter also references an April 2025 report issued by the Ethics & Public Policy Center (EPPC). The report claims that nearly 11% of women experience adverse side effects within 45 days of taking mifepristone, including sepsis, infection and hemorrhaging.

"The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of 'less than 0.5 percent' in clinical trials reported on the drug label," the EPPC report summary states.

Live Action also put out a video purportedly showing real calls with 27 Planned Parenthood locations across the U.S. In the video, a woman speaks with various Planned Parenthood locations about obtaining the abortion pill. The video appears to feature Planned Parenthood facilities in Alaska, Colorado, Kansas, Oregon, Minnesota, New Mexico and New York, with some states appearing multiple times.

The first section shows the woman asking whether the clinics need to see ultrasounds before prescribing the pill in order to assess the gestational age of the fetus. Many of those answering the phones at the Planned Parenthood locations said women could obtain the pill without an ultrasound through a telehealth appointment.

In the second section, the woman who called was told that Planned Parenthood would not test for Rhesus (Rh) incompatibility. Rh is a protein that some people carry in their blood, and it can cause issues in future pregnancies. 

A form from Planned Parenthood of Greater New York dated March 2020 states that, "There is a chance you might make Rh antibodies and have problems with future pregnancies. Research has not proved this."

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Live Action's video also purportedly showed that those who answered the phone at multiple Planned Parenthood locations assured the women that they did not need to give their medical history or attend an in-person follow-up.

It was unclear if the individuals who spoke with the woman had medical training. One suggested that the woman speak to a medical professional to get more accurate information on specific questions.

Those who answered the phone for clinics in multiple states also said the caller would be able to have the pills sent to another person's house. When asked whether the pills needed to be taken right away, most said they did not, with many assuring the woman calling that she could change her mind or wait to make a decision. However, the person on the phone at one clinic said that the woman had until 12 weeks to take the pill and advised that it would not be effective after that time.

Live Action released its letter and accompanying video ahead of the annual March for Life, which is scheduled for Jan. 23. Vice President JD Vance, who recently announced that he and his wife, Usha, are expecting their fourth child, is slated to speak at the march, as he did in 2025. Other speakers include House Speaker Mike Johnson, R-La., and Rep. Chris Smith, R-N.J.

In a statement to Fox News Digital, Planned Parenthood said its health centers that offer medication abortion "follow all applicable laws and regulations and always ensure care provided reflects the latest credible research and upholds the highest standard of patient care." 

"In accordance with Planned Parenthood Federation of America's medical standards and guidelines - which are developed and updated with medical experts across the field of sexual and reproductive health care using rigorous scientific evidence - providers at Planned Parenthood health centers explain the associated risks and benefits to patients seeking medication abortion, just as they do with every health care service provided," Danika Severino, Planned Parenthood vice president of care and access, said in a statement.

"Mifepristone is safe, legal, and has been used by more than 7.5 million people for abortion and miscarriage care since its approval by the U.S. Food and Drug Administration (FDA) 25 years ago," Severino added. "Despite 25 years of data and more than 100 peer-reviewed studies proving mifepristone is extremely safe and effective, anti-abortion activists continue to spread disinformation to advance their harmful political agenda."  

Fox News Digital also reached out to HHS and the FDA for comment.