By Anne Reed
Mifepristone, the drug used to kill children growing in the womb, originally known as RU486, was approved by the Clinton FDA in 2000. Then in 2016, Obama’s FDA approved the two-step chemical abortion process using mifepristone followed by misoprostol. Misoprostol was already approved to prevent ulcers; however, when administered after mifepristone, it “completes” an abortion by causing contractions that forcibly expel the deceased, tiny baby from the mother’s body.
In 2016, in-person medical consultations were still required before the pills could be dispensed – a safeguard to rule out ectopic pregnancy and other risk factors. But that same year, the FDA removed the requirement that a healthcare provider administer the pill in person.
A few years later, in April 2021, during the COVID-19 pandemic lock-downs, the FDA went further and temporarily suspended the in-person medical consultation requirement, which propelled the move toward mail-order abortions. Then, in its first order of business in 2023, the FDA moved beyond its negligent lack of enforcement and removed the in-person consultation requirement altogether.
Also, in early January, the agency changed the label of Mifepristone to allow retail pharmacies to distribute the drug. As the FDA continually loosens and abandons safety precautions, making chemical abortions more dangerous and accessible, concerned individuals and pro-life organizations have expressed strong opposition.
As a result, multiple efforts are underway to reverse the federal agency’s reckless decisions.
Legal Proceedings
The Alliance for Hippocratic Medicine (AHM) recently filed a lawsuit against the FDA. AHM’s attorneys argued that mifepristone is too dangerous and risky for use as an abortion drug, citing severe potential side effects. Additionally, it points out that while approved by the FDA, the safety and efficacy of this drug have not been established by any scientific testing or clinical trials.
According to Dr. Donna Harrison, CEO of the AHM, use of mifepristone has been associated with massive hemorrhage because it prevents blood vessels in the uterus from contracting.
“I’ve reviewed some of the adverse event reports sent to the FDA where women have lost over half of their blood volume,” she explained. “Some have lost more than their entire blood volume and had to have more than their entire blood volume replaced to keep up with the massive hemorrhage. So, this is the kind of bleeding you see in major motor vehicle accidents.”
Matthew J. Kacsmaryk, a U.S. District Court judge in Texas, appointed by former President Donald Trump, will be deciding the case as early as this month. If he rules in favor of AHM and orders the FDA to withdraw its approval of the dangerous abortion-inducing drugs, it would result in countless babies saved and women protected from painful, terrifying, life-threatening complications, or even death. His decision could:
- Eliminate mail-order options,
- Reinstitute the in-person dispensing requirement,
- Reassign dispensing authority exclusively to doctors (not allied health professionals like nurse practitioners and physicians assistants).
Legislator Pleadings
A commanding group of U.S. Senators (24) and members of the U.S. House of Representatives (53) are calling on the FDA to reverse its “dangerous, reckless, and illegal” decisions.
In a letter to the FDA Commissioner, the bicameral group details the legal faults in the agency’s initial approval of mifepristone, as well as the further elimination of the in-person dispensing requirement that has resulted in widespread availability of do-it-yourself abortion drugs.
“We call on the FDA to remove mifepristone from the market, or, at minimum, promptly restore and further strengthen the initial basic health and safety requirements for abortion drugs, and cease permitting the mailing and shipping of abortion drugs in violation of Federal criminal law,” they wrote. They further clarified the agency’s irresponsible leniency permitting no-test, mail-order abortions after a telemedicine visit is an abandonment of “its dual obligations to protect the public and vulnerable populations from harm and to comply with Federal law,” in that it:
- Threatens the health and safety of pregnant mothers by eliminating the requirement for in-person dispensing, increasing risks of potentially life-threatening complications without an in-person screening,
- Violates the FDA’s legal obligations to protect the safety of women and girls,
- Violates longstanding federal criminal laws barring the mailing and shipping of abortion drugs,
- Imperils the conscience rights of pharmacists by failing to provide protections for pharmacists who do not want to participate in abortion.
Legislative Action
Along the same lines, U.S. Sen. Cindy Hyde-Smith (R-MS) reintroduced the Support and Value Expectant (SAVE) Moms and Babies Act (S.95) last Thursday. By reinstating the in-person dispensing requirement, the measure would block distribution of the abortion drugs by mail, prescription by telemedicine, and would also improve the important reporting of complications.
In 2016, the FDA removed the reporting requirement documenting adverse reactions to the drugs. Because reporting is entirely voluntary, the agency’s recently released data from 2000-2022 is grossly incomplete:
- Deaths: 28
- Ectopic Pregnancies: 97
- Severe Infections: 71
- Infections: 414
- Blood Loss Requiring Transfusions: 604
- Hospitalizations (excluding death): 1,048 – averages nearly 50 per year
- Adverse Events: 4,213
Chemical abortion may seem like a simple alternative to abortion-vulnerable women who are likely accustomed to popping a pill to prevent pregnancy, but the reality is both risky and revealing.
In addition to the physical dangers associated with the drugs, women suffer from long-term psychological effects from the unexpected trauma they experience.
Though women have been legally subjecting themselves to surgical abortions for 50 years in the U.S., abortionists have had the ability to hide the bloody, dismembered children from their mothers’ view. But a woman who ingests the abortion-inducing drugs sees her dead baby, and then she pushes a lever and watches as her child’s tiny, precious body is flushed down the toilet – as if he or she is nothing more than human waste.
“We will continue to be on watch and report on efforts to bring an end to the availability of these dangerous, improperly used drugs,” said Operation Rescue President Troy Newman. “We are grateful for the work of the Alliance for Hippocratic Medicine, the Alliance Defending Freedom, and Senator Cindy Hyde-Smith and other pro-life legislators who are taking a stand against the FDA and its alarming lack of concern for the safety of women.
“Let’s continue to pray and speak truth on behalf of vulnerable babies and unsuspecting moms, many of whom are at immediate risk of death and severe injuries.”
