In late August, U.S. Senator Bill Cassidy (R-LA), chairman of the HELP Committee (Health, Education, Labor, and Pensions), released a startling report, “Mifepristone Without Guardrails: An Investigation Into How Chemical Abortion Drug Makers Are Putting Mothers and Babies At Risk.”
After investigating the three FDA-approved manufacturers of Mifepristone (Danco Laboratories, LLC; GenBioPro, Inc.; and Evita Solutions, LLC), the investigators found that all three companies fail to follow FDA safety regulations.
Mifepristone is regulated under the drug safety program called REMS (Risk Evaluation and Mitigation Strategies). This safety program includes the following guidelines. Health care providers must be able to:
- Assess the proper gestational age of the baby,
- Diagnose ectopic pregnancies,
- Perform surgery in cases of incomplete abortions or severe bleeding,
- Ensure patients have access to medical facilities that can provide blood transfusions and resuscitation.
As you know, the widespread online availability of the abortion drug, Mifepristone, makes all four of these safety requirements under the FDA unable to be followed.
Anyone, regardless of age, gender, or relationship to the baby can express order the abortion drug without parental consent, confirmation of pregnancy, known gestational age, knowledge of a health care provider, or access to any medical care.
The failure of these safety regulations is appalling and something that pro-life organizations, congressional committees, and more have been sounding the alarm on continually ever since the Biden Administration removed doctor requirements for Mifepristone.
The report notes that approximately 28 percent of all abortions happen chemically, using mail-order drugs. Given the lack of traceability with the online abortion drug, this number is undoubtedly higher.
Despite propaganda regarding the safety of Mifepristone that Planned Parenthood and its proponents try to promote, the evidence clearly displays the opposite.
Not only is Mifepristone deadly in most cases to the baby inside the womb, it is also extremely harmful to women.
As has been noted in previous articles, the EPPC (Ethics and Public Policy Center) published a study revealing the adverse events related to Mifepristone. According to the study,
- 1 in 10 (10.93%) of women will experience an adverse health event.
- This adverse health event rate is 22 times higher than what the FDA reports.
- This adverse health event rate skyrocketed after the Biden Administration removed in-person doctor visits as a requirement.
Among the adverse health events, the EPPC reported the following:
- Sepsis (0.10%),
- Infection (1.34%),
- Transfusion (0.15%),
- Hemorrhage (3.31%),
- Hospitalization related to the abortion (0.66%),
- ER visit related to the abortion (4.73%),
- Ectopic pregnancy (0.35%),
- Other life-threatening events such as cardiac, pulmonary, thrombosis, anaphylaxis, surgery (0.22%),
- Repeated surgical abortion (2.84%), and
- Other complications (5.68%)
The FDA must be held accountable for its negligence in all areas related to Mifepristone. The logical response to these reports would be for the FDA to pull Mifepristone from the market entirely.
The safety of babies and women depends on it.
