Abortion Pill

FDA Approves Generic Abortion Pill Despite Ongoing Safety Review

The Food and Drug Administration (FDA) approved a generic abortion pill just days after it confirmed its new investigation into the safety of chemical abortions.

The FDA approved Evita Solutions’ application for a generic mifepristone pill on September 30 after finding it “bioequivalent and therapeutically equivalent” to the name brand pill, Mifeprex.

Mifepristone starves preborn children of essential blood flow and nutrients by blocking the pregnancy hormone progesterone. It is the first chemical women ingest in the two-step chemical abortion regimen.

Watch Focus on the Family’s broadcast about the abortion pill.

The FDA’s authorization of another abortion pill seemingly contradicts its commitment to reevaluate mifepristone’s safety.

Just eleven days before its letter to Evita Solutions, FDA Commissioner Dr. Marty Makary and Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. confirmed the FDA is conducting an evidentiary review of the abortion pill.

“HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” the wrote in a letter to 22 concerned state attorneys general.

The AGs had requested HHS and FDA reinstate stringent restrictions on mifepristone in July.

When the FDA legalized mifepristone in 2000, it required:

  • The patient be less than seven weeks pregnant.
  • The patient visit the doctor three times before ingesting the drug.
  • The drug be prescribed by a doctor in a doctor’s office.
  • The drug be ingested in a doctor’s office with a doctor’s supervision.
  • The patient follow up with the doctor at least once after ingesting the drug.

Scientists used the same stringent restrictions in mifepristone’s clinical trials.

Today, the FDA requires none of these safety precautions. Women can be prescribed pills by doctors online or order them from legally-dubious websites. They do not have to get a sonogram to determine the age of their child or whether they have an ectopic pregnancy.  Most go through the painful abortion in their bathrooms alone.

In April, the Ethics and Public Policy Center (EPPC) released data showing just how dangerous taking mifepristone has become.

The bombshell report analyzed insurance claims from a representative sample of more than 865,700 chemical abortions. It indicated nearly 11% of women experienced a severe or life-threatening adverse event within 45 days of taking mifepristone, including:

  • Sepsis – 0.10% of cases (824 women)
  • Infection — 1.34% (11,707)
  • Required blood transfusion – 0.15% (1,257)
  • Hemorrhage – 3.31% (28,658)
  • Required hospitalization for complications related to the chemical abortion – 0.66% (5,699)
  • Required ER visit for complications related to the chemical abortion – 4.73% (40,960)
  • Ectopic pregnancy — 0.35% (3,062)
  • Other life-threatening adverse events related to the chemical abortion, including cardiac and pulmonary complications, anaphylaxis, thrombosis and surgery – 0.22% (1,956)
  • Repeated surgical abortion to complete the chemical abortion – 2.84% (24,563)
  • Other complications related to the chemical abortion, including life-threatening mental health diagnoses – 5.68% (49,169)

These findings indicate women are up to 22 times more likely to experience severe or life-threatening harm after taking mifepristone than the FDA had previously claimed.

HHS and FDA promised to investigate the discrepancy. In their September 19 letter, Kennedy and Makary wrote:

Recent studies — such as the study by the Ethics and Public Policy Center (EPPC) … — indicate potential dangers that may attend offering mifepristone without sufficient medical support or supervision.”

They further revealed the FDA itself had documented thousands of mifepristone-related adverse events before it eliminated the drug’s safety protocols:

FDA’s own data collected between 2000 to 2012 indicated 2,740 adverse events, including 416 events involving blood loss requiring transfusions.
Since then, safeguards for women regarding the administration of mifepristone have been significantly reduced.

Members of the House Values Action Team (VAT) team are among the legislators asking why, if mifepristone is dangerous enough to warrant a safety investigation, the FDA is approving more of the drug to hit shelves.

“The FDA’s approval of a new generic version of the abortion pill, mifepristone, endangers women’s health and disregards the value of life,” Congressman and VAT Chairman Robert Aderholt wrote in a statement.

“By approving another generic iteration of this pill while a safety review is ongoing, the FDA risks undermining women’s health and safety across the United States.”

Read more statements from more VAT members.

Neither Makary nor Kennedy had commented on the issue as of October 8.

The FDA has an urgent problem on its hands. Upwards of 11% of women may be suffering severe harm from chemical abortions, which are only growing more common. Meanwhile, the abortion industry claims mifepristone is safer than Tylenol.

The FDA should never approve drugs used to end human life. Barring a complete prohibition on mifepristone, the FDA should not approve generic abortion pills while investigation the drug’s safety.

To speak with a family help specialist or request resources, please call us at 1-800-A-FAMILY (232-6459).

If you are experiencing an unexpected pregnancy and want to learn more about your options, visit My Choice Network.

Some women, after taking the first abortion pill (mifepristone) come to regret their decision. Thankfully, there is a way to reverse the pill’s effects if prompt action is taken. To learn more about the abortion pill reversal protocol, visit abortionpillreversal.com or call 1-877-558-0333 to be connected with a medical professional who can guide callers through the process of reversing the pill’s effects.

To learn more about pro-life legislation in your state, contact your state Family Policy Council.

To learn more about the consequences of a chemical abortion, visit the links below.

Additional Articles and Resources

FDA Launches Review of Abortion Pill and the Harms it Causes Women

Pro-Abortion States Beef Up Protections for Abortion Pill Prescribers

Texas Father Sues Out-of-State Abortionist for Killing His Preborn Children

Shield Laws Enable Chemical Abortion in Pro-Life States

Shield Law Abortion Providers Advertised Alongside Black Market Abortion Pills

Texas Sues New York Doctor for Prescribing Abortion Meds

New Abortion Pill Study Confirms Danger to Mothers

Woman Nearly Dies from Abortion Pill, Story Reflects Disturbing EPPC Data

Focus on the Family Broadcast: Abortion Pill Reversal

#AbortionChangesYou: A Case Study to Understand the Communicative Tensions in Women’s Medication Abortion Narratives (Health Communication)

The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experiences a Serious Adverse Event (Ethics and Public Policy Center)

Pro-Life Investors and Shareholders Score Huge Win: Costco Will Not Carry Deadly Abortion Pills

On August 14, Costco quietly announced that it would not be selling dangerous abortion pills in its pharmacies, citing a lack of demand.

The pro-life community celebrated the news as one step in a long-term, multi-pronged effort to protect preborn human life.

What makes this moment especially significant is that it wasn’t just a spontaneous corporate decision made in a vacuum— it was the result of strategic and faithful persistence by pro-life shareholders and investors pushing back on Big Abortion demands to access the megaretailers’ pharmacies.

This type of successful pro-life investor and shareholder advocacy demonstrates that principled voices can influence even the largest companies, and that cultural change doesn’t just happen in courts or legislatures, but in American boardrooms, too.

Costco, and its 500 pharmacies nationwide, now join a growing list of retailers that have decided not to carry the deadly chemical abortion pills.

In January and February of this year, respectively, Walmart and Kroger confirmed they will not sell Mifepristone. In December 2024, Sam’s Club confirmed it does not carry the abortion pill.

These major retailers are responding, in part, to a multi-year campaign effort by faith-based investors led by Inspire Investing and legal advocates at Alliance Defending Freedom to keep abortion pills off the shelves.

“God wants His people managing His money for His glory according to His values.”

One year ago, in August 2024, Inspire Investing and Alliance Defending Freedom released letters representing a coalition of diverse financial investment firms with over $100 billion in assets.

The letters were addressed to the business executives at Costco, Walmart, Kroger, Albertsons and McKesson. They called on the leaders of those organizations to “resist political pressure to begin selling chemical abortion drugs at their pharmacies.”

The letters highlighted the controversial nature of the pills, the uncertain legality, safety concerns and the cost of alienating customers, not to mention shrinking the future customer base by facilitating the deaths of preborn babies.

The letters warned, “Dispensing it [Mifepristone] is filled with legal and political risk and will inject Costco into the middle of an intense political battle at great expense to its reputation. It is also wholly unnecessary to your business. We urge you not to dispense Mifepristone.”

In a statement following the Costco decision, Inspire Investing said,

We thank Costco for listening to our concerns and making a decision that serves their members, protects their brand, and avoids a divisive political fight.

This victory would not have been possible without the tireless support of our coalition partners, including Alliance Defending Freedom, the Ethics and Public Policy Center, Association of Mature American Citizens (AMAC), American Family Association, Idaho Family Policy Center, Salt and Light Catholic Radio, and numerous faith-based investors, as well as the 14 state treasurers who joined our efforts, the more than 9,000 individuals who signed our petition, and all the investors and citizens who spoke up.

Together, we made a real difference to protect the unborn and safeguard women’s health.

Big Abortion has used investor and stockholder influence for decades. It’s refreshing and exciting to see the pro-life movement use its influence in the financial industry to defend life.

This development is a major pro-life victory and unmistakable evidence that when we work together the pro-life community can drive meaningful change.

Image from Shutterstock.

Woman Nearly Dies from Abortion Pill, Story Reflects Disturbing EPPC Data

In April 2025, the Ethics and Public Policy Center (EPPC) released the largest-known study on the dangers of mifepristone – the first drug in a two-drug regimen called the “abortion pill.”

Their data, collected from insurance claims between 2017-2023, analyzes 865,727 cases of prescribed abortion pills in the United States – 28 times as many as were included in the FDA’s clinical trials on the drug combined.

The study explains,

10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.
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.
Mifepristone abortion, as currently practiced in the U.S., is considered more dangerous to women than is represented on the FDA-approved drug label.

The study also urges the Food and Drug Administration (FDA) to “further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.”

To some, these disturbing statistics may only appear as numbers on a page. However, each digit represents a real woman who has either narrowly escaped death or tragically lost her life to the abortion pill.

Here is just one of those stories.

Shanyce

When Shanyce went to Planned Parenthood for an abortion pill in early 2025, she reported feeling “no emotion.” “You’re here. Just get it done,” she told herself.

Shanyce took the first pill, mifepristone, at the clinic. This dose of the abortion pill is designed the block progesterone – an essential hormone for a healthy pregnancy. Mifepristone also thins the uterine lining and prevents vital nutrients from getting to the baby, causing the death of the preborn child.

Planned Parenthood sent Shanyce home with instructions to take a second pill, misoprostol, 72 hours later. This second dose causes the uterus to contract, expelling the dead baby from the mother’s body.

Accompanied with misoprostol are typical symptoms of miscarriage: abdominal cramping, bleeding, and discharge of tissue or fluid.

Shortly after Shanyce noticed these symptoms, her pain became excruciating.  She recalls,

The cramp was unbearable, like, it kinda felt like someone was stabbing me in my stomach. … It was really unbearable, I’ve never cramped like that before.

At the advice of her mother, Shanyce returned to Planned Parenthood. After an examination, a doctor told her there were no fetal remains left in her body:

They kinda like just brushed it off and was like, “hey these are the symptoms, like you’re fine.” And she sent me about my way.

Shanyce showed no improvement after returning home. Her mother noticed she looked “blue, pale … really lethargic and sick.”

Eventually, Shanyce’s mother insisted she go to the emergency room. After an ultrasound, the doctors informed Shanyce that her body still contained the dead remains of her child.

Shanyce was immediately rushed into surgery. She recalls,

I started getting a fever. I was throwing up constantly. I remember the first three surgeries that I had to remove the remains of the child, all my family came. They prayed over me, and that was kind of like the last thing I remember from there.

The abortion pill had given Shanyce an infection behind her uterus, forcing her to undergo a partial hysterectomy.

She later went into septic shock and was put into an induced coma.

Shanyce nearly died.

I wake up in ICU, on a breathing tube. I was on [a] blood transfusion, I had a stent in my neck. … I wasn’t able to talk til’ the next day.

Over the next few weeks, Shanyce relearned basic functions with the help of physical and occupational therapists:

They showed me how to step in and out of the shower, how to brush my teeth. I had to learn how to walk again after. I had to learn how to write, chew, talk a little bit, how to do daily things.

Shanyce was admitted to the hospital at the beginning of January. She was not released until the end of February – a long, traumatic hospital stay caused by both Planned Parenthood’s negligence and the abortion pill.

As reported by the EPPC, countless women like Shanyce have been deceived by the FDA’s false information about the abortion pill:

Danco Laboratories boasts that more than 5 million U.S. women have used its abortion pill since it was approved in 2000.

Even referring to the abortion pill as “medication” is a lie – “medication is intended to treat or cure diseases, and pregnancy is not a disease.”

Stories like Shanyce’s and the EPPC’s data undoubtedly prove the abortion pill is not safe:

Danco Laboratories markets Mifeprex as “the safe and effective abortion pill,” but our research shows that mifepristone abortion, as currently practiced in the U.S., is not safe and effective.
Women deserve better than the abortion pill.

Not only that, but every preborn baby deserves a chance to live.

Thankfully, FDA Commissioner Marty Makary has committed to reviewing the abortion pill’s safety profile. Hopefully the FDA will act to restrict the abortion pill’s use in the coming days.

Women, and preborn babies, would be much safer as a result.

To learn more about the abortion pill reversal protocol, visit abortionpillreversal.com or call 1-877-558-0333 to be connected with a medical professional who can guide callers through the process of reversing the pill’s effects.

To connect with a local pregnancy resource center that can discuss all of your pregnancy options with you, click here.  

Additionally, if you’re struggling and need a listening ear, Focus on the Family offers a free, one-time counseling consultation with a licensed or pastoral counselor. To request a counseling consultation, call 1-855-771-HELP (4357) or fill out our Counseling Consultation Request Form.

Related Articles and Resources:

Pro-Life: Focus on the Family

My Choice Network

New Abortion Pill Study Confirms Danger to Mothers

Here’s the Secret Pro-Abortion Activists Won’t Tell You About the Abortion Pill: It’s Dangerous

Shield Laws Enable Chemical Abortions in Pro-Life States

Shield Law Abortion Providers Advertised Alongside Black Market Abortion Pills

The Abortion Pill: How Does It Work?

New Insights on the Dangers of the Abortion Pill

Four Things to Know and Do About New Abortion Pill Study

A new study confirms what many have been warning about for years. The abortion pill doesn’t just take the life of innocent preborn babies but also injures and puts mother’s lives in jeopardy.

“The Abortion Pill Harms Women,” the largest ever examination of its kind, found that nearly 11% of all women who abort their child with mifepristone suffer from life-threatening conditions, including sepsis, infection or hemorrhaging.

Focus on the Family president Jim Daly stated this new report “calls out the chilling dangers of the abortion pill.” 

He added:

“For more than half-a-century, the radical abortion industry has been diminishing and discounting the health risks to unsuspecting women whenever preborn life is taken. All those who claim to be advocates for women should be alarmed and convicted by this new research.

“This 5-year study found that women are 22 times more likely to be harmed than previously suggested by the Food and Drug Administration. In the interest of the health of mothers alone, they should be calling for the FDA to investigate the use of these deadly and dangerous drugs. Millions of lives are at stake.

What can you about it?

  1. Call your elected representatives and request that the FDA reevaluate their assessment of the pill’s so-called safe use.

  2.  Volunteer for your local pregnancy center. The Lord can use you to help change the heart and mind of an abortion-minded woman. 

  3. Learn more about the severe and dangerous consequences of the abortion pill, as well as the abortion pill reversal process.

  4. Pray that the eyes of radical abortion activists will be opened and that their hardened hearts will be softened.

Your voice matters. Your hands can help make a difference. 

“We know the abortion kills the girl or boy on the inside, and now research makes clear it also harms the woman on the outside,” warned Jim Daly.

It is time to pray and time to act. 

New Abortion Pill Study Confirms Danger to Mothers

A new study from the Ethics and Public Policy Center (EPPC) confirms what many have been warning about for years. The abortion pill doesn’t just take the life of innocent preborn babies but also injures and puts mother’s lives in jeopardy.

“The Abortion Pill Harms Women,” the largest ever study of its kind, found that nearly 11% of all women who abort their child with mifepristone suffer from life-threatening conditions, including sepsis, infection or hemorrhaging.

Authored by Jamie Bryan Hall, EPPC’s Director of Data Analysis and EPPC president Ryan T. Anderson, the findings come just as the use of chemical (and often mail order) abortions are skyrocketing.

“This study is the statistical equivalent of a category 5 hurricane hitting the prevailing narrative of the abortion industry,” reflected Ryan T. Anderson.

“It reveals, based on real-world data, the shocking number of women who suffer serious medical consequences because of the abortion pill. The Trump FDA should take immediate action to protect the safety of American women by reinstating the safety regulations that the Obama and Biden Administrations removed.”

The study, conducted between 2017 and 2023, found that women are 22 times more likely to be harmed than previously suggested by the Food and Drug Administration.

In the simplest of terms, this new study confirms that the public has been consistently lied to or deceived about the so-called safety of the abortion pill.

In releasing the study, the EPPC is wisely calling for the FDA to reinstate “patient safety protocols” that were first promised when mifepristone was first released. Additional requests include:

  • Prescribing mifepristone and misoprostol for the termination of pregnancy should require at least three in-person office visits by the patient — as originally required by the FDA.
  • Mifepristone should be prescribed only by physicians — as originally required by the FDA — who have read and understood the prescribing information.
  • Mifepristone should be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies — all of which was originally required by the FDA.
  • Physicians must be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
  • Healthcare providers should be required once again to report to the FDA (and manufacturers of mifepristone) all serious adverse events resulting from the use of mifepristone.
  • Mifepristone should only be prescribed to a woman who is confirmed by a physician to be in the first seven weeks of pregnancy — as originally required by the FDA.

Abortion pill sycophants often dismiss warnings about the deadly pill as being hyperbole, but in releasing the new study, the EPPC even provides tragic testimonies from women who have suffered from its use.

Sadly, there are many no longer alive to talk.

Public policy impacts real people in real time and nowhere is this truer than when it comes to the reckless and tragic distribution of the abortion pill.

The FDA is long overdue to study and re-investigate the abortion pill’s so-called safety. This landmark new study will hopefully trigger and expedite that process.