By Tyler Arnold
Washington, D.C. Newsroom, Feb 12, 2024 / 07:00 am
The United States Conference of Catholic Bishops (USCCB) published a document to explain its concerns about the Food and Drug Administration’s (FDA) approval and deregulation of a chemical abortion pill, which is the subject of an ongoing U.S. Supreme Court case.
A lawsuit filed by the pro-life Alliance for Hippocratic Medicine accuses the FDA of failing to properly study the adverse effects of the drug when approving its use and when eliminating certain safeguards, such as approving delivery via the mail and ending the requirement for an in-person doctor’s visit before getting the prescription.
“Potentially harmful drugs [will] be mailed directly to girls and women who did not see a medical professional in person and may be injured or killed without public knowledge of the cause” if the current FDA policies are allowed to remain in place, the bishops warned in a “Question and Answer” document published by the USCCB’s Secretariat on Pro-Life Activities.
How the abortion drug works
The FDA approved the chemical abortion drug in question, called mifepristone, in 2000 and subsequently deregulated the drug. The rules allow a pregnant woman to take the drug up to 10 weeks into her pregnancy, at which point her preborn child will have a fetal heartbeat, early brain activity, and partially developed eyes, ears, lips, and nostrils.
Mifepristone kills the baby by blocking the hormone progesterone, which cuts off the child’s supply of oxygen and nutrients. A second pill, misoprostol, is taken between 24 to 48 hours after mifepristone to induce contractions meant to expel the child’s body from the mother, essentially inducing labor.
“Proponents call it ‘medication abortion,’ but that is misleading,” the bishops said. “‘Medication’ indicates something to manage a patient’s illness. The first drug, mifepristone, … was not developed as a treatment or cure, but to end a child’s life. Thus ‘chemical abortion’ is the more accurate term.”
Dr. Ingrid Skop, an obstetrician-gynecologist and director of medical affairs at the pro-life Lozier Institute, told CNA that there is a “common confusion” that these drugs are like contraception.
Unlike contraception, which Skop said “hopes to prevent a new human life from occurring,” the abortion drugs “are used when a pregnancy is known to exist and the intent of these drugs is to end that unborn human life.”
Concerns about safety
The bishops’ document cited a number of safety concerns, which included blood loss, infections, and even death, noting that the rate of adverse effects from chemical abortions is more than 5%, which is four times higher than first-trimester surgical abortions.
“The FDA’s record of ‘adverse events’ cites 28 women’s deaths between September 2000 and June 2022,” the document noted, citing a 2022 FDA document. “Although the FDA stopped requiring reports of non-fatal adverse events in 2016, it reports a total of 4,213 adverse events, including 1,048 hospitalizations (excluding deaths), 604 cases of blood loss requiring transfusions, 97 ectopic pregnancies, and 414 infections (71 of them ‘severe’).”
However, the bishops argued that the number of women who have adverse effects is likely higher, citing a 2015 peer-reviewed study that found more than one-third of women wound up in an emergency room within 30 days after having a chemical abortion.
“Complications are likely underreported in the U.S., as many are treated in hospital emergency rooms where physicians may not know about the abortion or not code it as such in medical records,” the document reads.
Skop agreed with that characterization, telling CNA that adverse effects from chemical abortions are more common than adverse effects from surgical abortions, but that the number is likely higher than reported: It’s “very difficult … to know how many complications” there are,” she said.
“Most abortions are paid for privately, women are often ashamed or embarrassed and don’t want to talk about their abortion,” Skop added.
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FDA deregulation creates more concerns
The bishops further warned about the lack of safeguards through deregulation. The document expresses concern that the FDA regulations do not require in-person doctor visits, allow the drug to be delivered through the mail, and permit access to minors. They caution that the potential adverse effects of this deregulation were never properly studied.
“The FDA also set no age restrictions, despite the absence of a study establishing the drugs’ safety for minor girls — and it failed to incorporate safeguards used in the clinical trial submitted to justify FDA approval, such as the requirement for an ultrasound exam to confirm gestational age and detect a dangerous ectopic pregnancy,” the document noted.
Dr. Robin Pierucci, a neonatologist and co-chair of the pro-life committee at the American College of Pediatricians, told CNA that the lack of safeguards has left “women with unplanned pregnancies … medically and legally abandoned.”
“Because the FDA removed both the mechanism for reporting side effects as well as an in-person medical examination prior to taking mifepristone, women’s health has been compromised,” Pierucci said. “Without supervision and an ultrasound, there is no way to diagnose ectopic pregnancies (mifepristone and an ectopic pregnancy have similar symptoms), the pregnancy may be more advanced than thought (increasing the risk of complications), and sexually transmitted infections will be missed. Without supervision, severe bleeding can be life-threatening or become serious due to prolonged bleeding for weeks. Afterward, an infection with or without issues from an incomplete abortion can be lethal.”
Skop said the deregulation proves that the pro-abortion movement will “prioritize the death of the unborn child over the health and safety of the mother” and that “if the women are injured, they’re collateral damage” to them.
“We’re seeing some very evil ideology in our country and in our world today,” Skop said.
The current status
The United States Supreme Court agreed to hear the lawsuit challenging the approval of the abortion drug and the subsequent deregulations. The bishops noted that the outcome could have a major effect on abortion throughout the country, noting that about half of all abortions performed in the United States are chemical abortions.
“Many states have responded by enacting laws against abortion, which could be explicitly overturned or rendered ineffectual by a federal mandate to allow delivery of abortion drugs through the U.S. postal service,” the document notes. “This case will help determine whether abortion is promoted throughout the country as a routine form of ‘medication.’”
