mifepristone

Pro-Life Groups Raise Alarm Over Delayed FDA Review of Abortion Pill Safety

Pro-life organizations and advocates called for the FDA Commissioner to be fired this week over the failure of FDA health officials to review abortion pill safety.

The abortion pill is a two-step process. The first pill, mifepristone, prohibits a baby’s further development and eventually starves it. The second pill, misoprostol, expels the baby from the mother’s body.

As reported by the Daily Citizen, in May, the Ethics and Public Policy Center released a study revealing nearly 11% of women who take the pill experience serious adverse effects, including sepsis, hemorrhaging, infection, and emergency room visits.

That is 22 times higher than the FDA’s current label, which suggests the rate of adverse effects is only 0.5%.

When Senator Josh Hawley addressed the study with Health and Human Services Secretary Robert Kennedy at a senate hearing later that month, Secretary Kennedy acknowledged the data was “alarming” and pledged HHS would perform a “complete review” of mifepristone.

Since May, the FDA has not completed a review of mifepristone, and instead approved a generic version of the drug at the end of September.

In a post on X, Senator Hawley called the approval “shocking.” He declared:

I have lost confidence in the leadership at the FDA. [The] FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead, they’ve just greenlighted new versions of it for distribution.

Now, Susan B. Anthony Pro-Life America claims FDA leadership intentionally slow-walked the promised review of mifepristone and is calling for the FDA Commissioner Marty Makary to be fired.

Senator Hawley recently released his letter to the FDA Commissioner, calling on the agency to stop stonewalling the review and reinstate the mifepristone safety protocols instated during the first Trump Administration.

Live Action’s President Lila Rose called on the FDA to act immediately to protect children and mothers from mifepristone.

To date, the White House and Department of Health and Human Services deny slow-walking the review and maintain it simply takes time.

For now, mifepristone and its generic counterpart remain available to the public under existing FDA authority, and no leadership changes have been announced. But there is growing pressure for the FDA to complete the promised safety review.

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.

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:

RFK Jr. Announces ‘Complete Review’ of Abortion Pill After ‘Alarming’ New Study Reveals Dangers

Louisiana, ADF Challenge Biden-Era Abortion-By-Mail Scheme

FDA Approves Generic Abortion Pill Despite Ongoing Safety Review

Become an Option Ultrasound Life Advocate

Dealing With an Unplanned Pregnancy

I’m Pregnant, Now What?

My Choice Network

New Insights on the Dangers of the Abortion Pill

The Telephone Used to Save Lives. Now It Takes Them.

When Alexander Graham Bell was granted the first patent for the telephone in 1876, most people saw the invention as a triumph of mankind’s longtime challenge to communicate nearly instantaneously over long distances.

First through telegraph and then telephone, the first devices were primarily used by post offices, railroads, stock exchanges, newspapers and the wealthy – all to relay time-sensitive and urgent information.

The telephone was also used to save lives – mainly to call doctors and hospitals seeking help for sick or distressed patients.

Tragically, telecommunication technology is now being used to help facilitate the deaths of hundreds of thousands of pre-born children every year. From Tuesday’s New York Times:

Last year, one out of four abortions nationwide was provided via telehealth, compared to 5 percent before 2022, according to WeCount, a study led by the Society of Family Planning. And in states where abortion was totally banned, 99 percent of abortions were provided by telehealth.
“The reality is people are getting abortions, people are providing abortions, and the post-Dobbs environment is not stopping them,” said David Cohen, a law professor at Drexel University who co-wrote the book “After Dobbs.”

Despite bans or restrictions on abortion in upwards of 20 states, doctors in abortion-friendly states are mailing deadly drugs to patients, who then self-administer the toxic cocktail.

A new law in Texas now bans this practice. HB7, which went into effect last week, permits Texas citizens to sue abortion pill distributors for at least $100,000 per violation.

Predictably, abortion advocates are criticizing the legislation, calling it an intimidation tactic against doctors and a pseudo spy campaign that incentivizes private citizens to pry into people’s private lives.

Texas joins seven other states either banning the mailing of abortion pills or telehealth abortion: Arizona, Florida, Indiana, Kentucky, Oklahoma, South Carolina, and West Virginia.

Radical abortion enthusiasts have polished and perfected their talking points. Dr. Ushma Upadhyay, who is a professor and a public health scientist at the University of California, San Francisco, uses soft words to describe the hard truth about what’s at stake.

“All of this legislation will never take away from the fact that women will continue to need abortion care, and continue to get abortion care,” she says.

Merriam-Webster defines “health care” as “efforts made to maintain, restore, or promote someone’s physical, mental, or emotional well-being especially when performed by trained and licensed professionals.”

“Abortion care” is a term that’s been widely adopted – and widely abused. There is no such thing. Abortion isn’t a form of “care.” It doesn’t maintain, restore or promote anything – it destroys and decimates innocent life and inflicts long-term psychological damage on the mother.

The zealots wanting to allow the unfettered killing of preborn children are right that pro-life advocates have declared war on telehealth abortion. That’s because it not only destroys innocent life but also threatens the health and life of the mothers who often blindly ingest the toxic pills thinking they’re the equivalent of taking an aspirin.

Telecommunication isn’t the first invention to be coopted for evil purposes. Going back to fire itself, the broken and sinful have regularly misused and abused all types of discoveries and inventions. Telehealth allows those either unable to leave their homes or those without access to adequate medical care get the help they need. Legislators are wise to wrestle back control of it from those committed to corrupting and leveraging it for evil purposes like abortion.

Florida Sues Planned Parenthood for Falsely Claiming Abortion is ‘Safer Than Tylenol’

Recently, Florida’s Attorney General filed a lawsuit against Planned Parenthood for falsely advertising chemical abortion as “safer than Tylenol.” The lawsuit alleges Planned Parenthood promoted this claim to sell abortion-inducing drugs, like Mifepristone, while downplaying the potential risks for women.

Planned Parenthood claims, “Mifepristone is safe. Safer than Tylenol.” Florida’s complaint alleges this statement is “manifestly false.”

The state contends this deceptive advertising violates state consumer protection and racketeering laws:

“Planned Parenthood’s campaign to induce women to purchase abortion drugs by misrepresenting the risks of chemical abortion violates the Florida Deceptive and Unfair Trade Practices Act (FDUTPA) and constitutes a pattern of racketeering activity under the Florida Racketeer Influenced and Corrupt Organization Act (the Florida RICO Act).”

The lawsuit cites a recent study released by the Ethics and Public Policy Center, “The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experiences a Serious Adverse Event,” which “found that 11% of women experience a serious adverse event like sepsis or hemorrhaging within 45 days of a chemical abortion.” 

As reported by the Daily Citizen, the research revealed the complication rate for the chemical abortion regimen “is 22 times higher than the FDA’s current label, which suggests the rate of adverse effects is only 0.5%.”

Earlier this year, Secretary Kennedy instructed the FDA to do a “complete review” of the chemical abortion pill. Kennedy said HHS would make recommendations based on the data, but decisions on regulation would come from the White House. HHS is still conducting their investigation.

Florida’s Attorney General alleges tens of thousands of Florida women have been misled about chemical abortions by Planned Parenthood’s deceptive marketing, in violation of the state’s law prohibiting “unfair or deceptive acts or practices in the conduct of any trade or commerce.”

Florida also contends Planned Parenthood violates state RICO law by acting in a pattern of racketeering activity. The complaint alleges Planned Parenthood committed this violation by disseminating “multiple ‘Safer than Tylenol’ advertisements with the same or similar intent (to induce women to purchase chemical abortions), results (the purchase of chemical abortions), accomplices (codefendants), victims (women purchasing chemical abortions) and methods of commission (through representations on the PPFA website and representations or omissions made by Planned Parenthood affiliates).”

The advertisements are also interrelated (not isolated incidents), frequent and ongoing, per the complaint.

The complaint asks the court to order all defendants to stop saying abortion is safer than Tylenol, to pay statutory penalties of $350 million and a $1 million civil penalty per defendant (Planned Parenthood of America, Planned Parenthood Action Fund, Planned Parenthood of Florida and Planned Parenthood Florida Action) for violating state law, and any other penalty the court sees fit.

Planned Parenthood denies the allegations. They contend the lawsuit is politically motivated and not based in facts. They have not filed a written legal response to the complaint as of November 21.

The question before the court will be whether Planned Parenthood’s phrasing crosses a legal line into consumer deception. The court’s answer has the potential to reshape how abortion providers communicate risks, how states regulate healthcare advertising, and how consumer protection laws can be used to protect women from the dangers of abortion.

The Daily Citizen will continue to follow this developing story.

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.

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:

RFK Jr. Announces ‘Complete Review’ of Abortion Pill After ‘Alarming’ New Study Reveals Dangers

Louisiana, ADF Challenge Biden-Era Abortion-By-Mail Scheme

FDA Approves Generic Abortion Pill Despite Ongoing Safety Review

Become an Option Ultrasound Life Advocate

Dealing With Unplanned Pregnancy

I’m Pregnant, Now What?

My Choice Network

New Insights on the Dangers of the 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-Abortion States Beef Up Protections for Abortion Pill Prescribers

Pro-abortion states are passing laws stripping prescriber names off chemical abortion pill labels.

The laws further insulate doctors who prescribe chemical abortion pills to people in pro-life states from investigation and prosecution.

Prescription Label Laws

New York, Maine, Vermont, Washington and Colorado have passed laws allowing prescribers to remove their names from prescriptions for mifepristone and misoprostol, the drugs used in a chemical abortion.

The laws make it nearly impossible for pro-life states to identify out-of-state, online abortionists—let alone investigate or sue them.

It’s unclear whether this kind of legislation is even legal; federal law requires prescriber names appear on all drug labels. But, so far, the laws remain unchallenged — and deeply problematic for pro-life states.

Importantly, prescription label laws making abortionists anonymous cover both local doctors prescribing abortions and doctors from other states that fill orders through local pharmacies. That means a mail-order abortionist in California could strip his name from a chemical abortion prescription if he filled the script at a pharmacy in New York.

California hopes to capitalize on this loophole by passing AB 260 — a bill that would remove both prescriber and patient names from chemical abortion pill labels. Most pharmacies that dispense mifepristone are in California, according to the left-leaning news outlet 19th Street

AB 260 is awaiting committee action in the California Senate. It passed the Assembly in May.

Shield Laws

Prescription label laws anonymizing abortionists beef up pro-abortion “shield laws” against pro-life judicial challenges.

States with abortion “shield laws” promise not to investigate out-of-state abortion providers or cooperate with investigations and prosecutions from pro-life states.

Eight states — California, Colorado, Maine, Massachusetts, New York, Rhode Island, Vermont and Washington — have shield laws explicitly protecting doctors who prescribe chemical abortions to patients in other states.

Fifteen others offer at least some protection from pro-life states’ investigations.

Of the 95,710 abortions prescribed or performed nationwide in December, an estimated one-in-seven were prescribed to women in pro-life states by abortionists in shield law states, according to a Kaiser Family Foundation analysis of data collected by the Society of Family Planning.

Pro-Life Challenges to Shield Laws

Pro-life states are workshopping ways to circumvent shield laws in court.

Louisiana and Texas pursued state judgements against Maggie Carpenter, a New York mail order abortionist, earlier this year— but they proved impossible to enforce without New York’s cooperation.

Now, pro-life states are empowering individual citizens to sue out-of-state abortionists for wrongdoing.

In July, Texas father Jerry Rodriguez sued California abortionist Remy Coeytaux in federal court for the wrongful death of Rodriguez’ pre-born children. A federal judgement in favor of Rodriguez would effectively strip Coetytaux of California’s shield law protections.

A Louisiana law allowing citizens to sue out-of-state abortionists, and extending the statute of limitations on abortion lawsuits to five years, took effect earlier this month.

Prescription laws anonymizing abortionists make it harder to file lawsuits like these by hiding the offenders’ identity.

Why It Matters

Chemical abortions are extremely dangerous. Nearly 11% of the more than 865,000 women who filed insurance claims for chemical abortions between 2017 and 2023 experienced severe adverse medical events within 45 days of taking mifepristone, according to data analysis by the Ethics and Public Policy Center, including:

  • Sepsis
  • Infection
  • Blood loss requiring a transfusion
  • Hemorrhage
  • Related hospitalization
  • Related ER visit
  • Related life-threatening cardiac, pulmonary and allergic reactions
  • Repeated surgical abortion
  • Other severe or life-threatening abortion-specific complications

Out-of-state, online abortion providers compound these dangers by prescribing abortion pills to:

  • Women more than 10-weeks pregnant, which is the FDA’s gestational limit for chemical abortions.
  • Teenage girls, often without parents’ consent, and even though mifepristone has never undergone pediatric testing.
  • Women who have not had an ultrasound, which doctors use to detect dangerous ectopic pregnancies mifepristone can disguise.
  • Women who will take the pills without a doctors’ supervision, which greatly increases the rate of complications.
  • People on behalf of women, which can indicate a woman is being coerced or tricked into getting an abortion.

Pro-abortion states should not be allowed to absolve abortionists of responsibility for the harms their actions cause vulnerable women.

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

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)