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)
