'Serious risk': Coalition urges HHS and FDA to pull abortion pill's approval

Live Action and a coalition of more than 25 pro-life groups and individuals have issued a letter to Health and Human Services Secretary Robert F. Kennedy Jr. (RFK) and Food and Drug Administration (FDA) Commissioner Marty Makary, seeking a reversal of the FDA's recent decision to approve another generic version of the abortion pill, and a removal of the lethal drug from the market.

Key Takeaways:

• Live Action and more than 25 other pro-life groups and individuals are asking for a reversal of the FDA's decision to approve another generic version of mifepristone, the abortion pill.

• HHS Secretary Kennedy had previously stated that a thorough review of the abortion pill's safety would take place at HHS via the FDA.

• Several studies have revealed that the FDA's mifepristone label lists a far lower serious adverse event rate than several studies and analyses have shown in recent years.

• The fact that the abortion pill is available by mail-order and available by a 'no-test' protocol leaves women at risk for many issues, including that they are more susceptible to forced abortion, as several cases have already demonstrated.

The Details:

On October 2, Live Action News reported that the FDA had issued an approval to Evita Solutions, LLC, a pharmaceutical company, for its generic version of Mifeprex (mifepristone 200mg), on September 30, 2025 — less than two weeks after RFK and Commissioner Makary notified 22 state attorneys general, who requested a review in light of a new analysis, that HHS would be "conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug...."

In addition, as the coalition letter notes:

Secretary Kennedy stated on September 4, 2025, during the Senate Finance Committee hearing, “... during the Biden Administration, they actually twisted the data to bury one of the safety signals, a very high safety signal, around 11 percent. We’re going to make sure that doesn’t happen anymore.”

"Yet," as the coalition letter noted, "rather than pausing to examine the mounting evidence showing the harmful effects of mifepristone, the FDA has chosen to expand access to a drug that has already killed millions of preborn children and harmed countless women, undermining the very commitment that the Secretary publicly made to protect patients."

The letter calls the decision "reckless" and asks for the decision to "be immediately reversed, and mifepristone should be pulled from the market altogether," as "This approval directly contradicts Secretary Kennedy’s recent public assurances that the safety of abortion drugs was in question and would receive thorough review."

Signers include Live Action founder and president Lila Rose, Students for Life president Kristan Hawkins, Ethics and Public Policy Center president Ryan Anderson, Concerned Women for America CEO and president Penny Nance, Thomas More Society Executive VP Peter Breen, Heartbeat International president Jor-El Godsey, and many others.

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🚨 The @FDA has recklessly approved a new generic version of the abortion pill. This decision must be reversed IMMEDIATELY. This drug has killed MILLIONS of preborn babies. ONE in TEN women experience serious adverse effects. This approval directly contradicts Secretary

7:44 PM · Oct 3, 2025

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The letter notes that "Chemical abortions now account for nearly two-thirds of all abortions in the United States, ending the lives of an estimated 7.5 million children since mifepristone’s initial approval in 2000," and explains the deadly abortion pill procedure, in which a pregnant woman takes mifepristone, which deprives the preborn baby of nutrients needed to grow, by blocking the pregnancy hormone progesterone. Several hours later, the woman takes misoprostol, which essentially induces labor, and the woman expels the body of her baby:

1st Trimester Abortion | The Abortion Pill | What Is Abortion?

The coalition letter points out that "the Ethics and Public Policy Center [EPPC] analyzed 865,727 chemical abortions between 2017 and 2023 and found that more than one in ten women experienced serious, sometimes life-threatening complications, including hemorrhage, infection, and sepsis. This complication rate is twenty-two times higher than the Food and Drug Administration’s own outdated claims."

The letter also notes that:

In contrast to the depth and rigor of the newly available data, the FDA-approved labeling for mifepristone is based on only ten clinical trials involving fewer than 31,000 women, some of which date back more than forty years. This creates a dangerous disconnect: women today are told these drugs are “safe,” when the best available evidence shows the opposite.

"Meanwhile, the Biden administration stripped away even minimal safeguards," the letter added, "allowing these drugs to be dispensed through telehealth and mail-order pharmacies. This reckless policy creates an alarming number of opportunities for coercion and abuse."

What's Happening:

Many men have obtained the abortion pill and forced it upon pregnant women without their knowledge or consent. It has happened in the UK, where mail-order abortion pills have been allowed since the COVID-19 pandemic, and in the U.S. For example:

• A UK man obtained the abortion pill drug regimen by mail-order, and mixed crushed mifepristone into a woman's orange juice. He later secretly administered misoprostol to her. Her preborn child died. He was sentenced to 12 years in prison.

• In Wisconsin, a man was sentenced to 20 years in prison in 2022 for using the abortion pill regiment to force an abortion upon a woman who was 21 weeks pregnant. Her baby died.

• Also in the U.S., a Texas woman is suing her ex-partner for allegedly spiking her drink with the abortion pill obtained from mail-order abortion pill distributor, Aid Access.

As the coalition letter notes, there is a "need for stronger safeguards and enforcement to protect innocent lives from these dangerous drugs and unlawful practices."

But it isn't just coercion that is the problem; the abortion pill is far less safe than is claimed, regardless of whether coercion plays a role. The EPPC's analysis shows an 11% ER visit rate, a recent study out of Ireland shows a 12% rate, and other studies show a far higher rate than is listed on the FDA's mifepristone label.

The Bottom Line:

The letter is asking for the FDA to "conduct a thorough and proper review of mifepristone, as promised by Secretary Kennedy," adding that "Mifepristone is not medicine. It is a lethal drug designed to end the life of an unborn child, and in doing so, it places women at serious risk."

The coalition is seeking not just a reversal of the generic abortion pill's approval, but a withdrawal of mifepristone from the market.