A Christian Resource

Pro-life groups are warning against the Food and Drug Administration for permanently eliminating the in-person dispensing requirements for the abortion pills, thereby allowing women to obtain the drugs by mail and end their pregnancy without seeing a doctor first.

On Thursday, Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, sent a letter to Dr. Graham Chelius of the Society of Family Planning informing him that the agency intended to modify the Risk Evaluation and Mitigation System (REMS) program for the abortion pills, referred to in the letter as Mifepristone. “The agency has determined that the Mifepristone REMS Program continues to be necessary to ensure that the benefits of the drug outweigh the costs,” she wrote.

“However, we have determined that it must be modified to minimize the burden on the health care delivery system of complying with the REMS and to ensure that the benefits of the drug outweigh the risks,” Cavazzoni said.

“The modifications to the REMS will consist of: (1) removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices and hospitals (i.e., the ‘in-person dispensing requirement’); and (2) adding a requirement that pharmacies that dispense the drug be specially certified.”

In a chemical abortion, women are given two drugs: mifepristone or RU-486, and misoprostol. Mifepristone works by blocking the effects of the natural pregnancy hormone progesterone. Misoprostol induces contractions and a miscarriage.

The Society of Family Planning sent a letter to the FDA earlier this year arguing that the in-person dispensing requirement for the abortion pills “confers no benefit in terms of safety, efficacy, or acceptability of the drug mifepristone and instead creates barriers to use that negatively impact public health and equity in access to care.”  

The Society of Family Planning’s letter followed the FDA’s May 7 announcement that it was reviewing the REMS and its April announcement that it was suspending the in-person requirements for the duration of the coronavirus pandemic.

Pro-life groups condemned the FDA’s move to permanently lift the in-person dispensing requirement for the abortion pills, also known as a chemical abortion.

Tessa Longbons, the senior research associate at the Charlotte Lozier Institute, pushed back on the idea that the abortion pills are safe and not in need of “safeguards,” such as the in-person dispensing requirement: “Peer-reviewed research confirms a 500% increase in the rate of chemical abortion-related emergency room visits.”

“The FDA claims that complications are rare, yet peer-reviewed research from the United States, Finland and Sweden confirms the abortion [pills have] a much higher complication rate than surgical abortion,” she added. “As a woman who has studied abortion trends on a state-by-state level and analyzed major studies on chemical abortion, I find today’s FDA decision to be historically bad. The FDA is putting women and girls at considerable risk through regulatory malpractice.”

Stephen Billy, Charlotte Lozier Institute’s executive director, characterized the FDA’s move as a “Christmas gift” to the abortion industry. Sue Liebel, state policy director for the pro-life group Susan B. Anthony List, elaborated on how “the Biden administration’s reckless move puts countless women and unborn children in danger” in a statement.

“Abortion activists’ longtime wish has been to turn every post office and pharmacy into an abortion center. They promote abortion drugs as easy, painless and private. Science says otherwise. Women who take chemical abortion pills are significantly more at risk of serious complications and more likely to require a visit to the emergency room,” she added.

Some women even die. Already-exhausted ER doctors and nurses will be forced to ‘clean up after’ an abortion industry that puts profits before safety and won’t regulate itself — all to please [President Joe] Biden’s radical base and pay back political allies.”

In a statement, Carol Tobias, president of the National Right to Life, asserted that “the FDA’s decision today places women at risk.” According to Tobias, “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

“The FDA knows the dangers of this abortion drug combination, but in the name of political expediency, has limited the safety measure requiring an in-person doctor’s visit,” she continued. “With this move today, the FDA further expands the scale of chemical warfare on the unborn, putting the lives and health of hundreds of thousands of women at risk for the sake of a powerful, political abortion industry.”

Tobias characterized the “experiment with mail-order abortion” as a “deadly experiment with women’s lives.” She maintained that “women are at risk everywhere because abortion activists want abortions to be available at any time, anywhere, and for any reason.”

“Making this change permanent puts women at greater risk because they may not be adequately screened to make sure they have no disqualifying conditions like allergies or ectopic pregnancy and are not so far along that the drugs will not work or are more likely to result in life-threatening complications,” warned Randall O’Bannon, director of education and research at National Right to Life.

O’Bannon expressed concern that “Without that screening or monitoring, the likelihood of hemorrhage, infection, and missed ectopic pregnancy are greatly increased, and there is a greater possibility that a woman experiencing these adverse events may end up in the emergency room and could arrive too late for life-saving treatment.”

The FDA’s abandonment of the in-person dispensing requirement for the abortion pills comes as the U.S. Senate is considering Robert Califf, Biden’s nominee to serve as the commissioner of the FDA. Pro-life groups have also spoken out in opposition to Califf’s confirmation, citing his efforts during his previous tenure as FDA commissioner during the Obama administration to allow abortion pills to be taken as late as 10 weeks into a pregnancy.

While Students for Life of America President Kristan Hawkins urged senators to oppose Califf in a letter, four Republican senators have already indicated that they plan to support his confirmation. Meanwhile, Sens. Bernie Sanders, I-Vt., and Joe Manchin, D-W.Va., have come out against Califf’s confirmation, although they cite reasons other than his actions on behalf of chemical abortions. 

In a previous interview with The Christian Post, Sue Turner, director of Physicians for Life, said that when mifepristone first came out, the U.S. FDA had a protocol for it to be used through seven weeks or 49 days from conception. 

Because many abortion clinics in the U.S. were ignoring the FDA’s protocol and using the drug in chemical abortions up to 60 days, states began passing regulations saying they had to follow the FDA’s protocol. “They didn’t want to have to follow the FDA protocol, so [then President] Obama made the FDA change it to the later date, the 60 days, to match up with what the abortion providers were doing.

“The drug was less effective,” she said, “and abortionists then had to also perform a surgical abortion, which meant that women were being charged for both chemical and surgical procedures.”

Describing the complications that arise from taking abortion pills [specifically misoprostol, the second pill] that induce a miscarriage, Turner added: “I shudder to think what happens to her and what she goes through in that process because in about 30 minutes she starts having horrific contractions. And women can die. If the cervix doesn’t open it can cause all kinds of horrible problems for her.”

As the medical director of a 50-bed neonatal intensive care unit (NICU) that cares for babies born weighing less than 3 pounds and 5 ounces, I was frankly shocked by Justice Sonia Sotomayor’s outdated assertion last week that very few doctors — she called us “a gross minority” — believe pre-term babies can experience pain at younger than 24 or 25 weeks gestation. 

During the Supreme Court oral arguments on Mississippi’s 15-week limit on elective abortions, Justice Sotomayor was openly skeptical that advancements in science and medicine over the last 30 years have any bearing on fetal viability. She questioned whether a baby’s pain is even relevant to the abortion debate and declared the idea of early fetal pain is “not well founded in science at all.” She described doctors who take fetal pain seriously as “fringe.” 

Science has not stood still since Roe was decided in 1973. Modern studies demonstrate improved outcomes for babies born on the edge of viability when their pain is avoided, mitigated, or treated. So, it’s good that neonatologists and anesthesiologists are not listening to Justice Sotomayor’s clinical advice. Treating pain in our very youngest patients is not a fringe or fluky thing to do; it is our current, evidence-driven, medical standard of care.

Neonatal medicine treats newborn babies, including those born prematurely.  Today some top neonatal intensive care units report that more than 3 out of 4 premature babies born at 22-23 weeks survive. Just a few decades ago medical intervention at 22 weeks was never even a consideration.

The remarkable progress in prenatal and neonatal care is due to advancing medical technology but also to advancements in patient care, including a priority on minimizing the baby’s pain before and after birth. As one example, during fetal surgery anesthesia is routinely administered both to the mother and the unborn baby. Intentionally decreasing painful procedures (such as blood draws) and avoiding noxious stimulation (such as interrupting an infant’s natural sleep time to check their blood pressure) have contributed measurably to the positive outcomes for babies at the edge of viability.

In fact, the presence of pain in premature infants is so uncontroversial that recent studies involve not only decreasing and/or treating pain, but also reevaluating how to make the neonatal environment more soothing. The science indicates that it is specifically our tiniest, most premature babies that benefit from these adjustments. 

During last week’s Supreme Court hearing, Justice Sotomayor cited outdated science in another way. She referred to a 2010 study that concluded preborn infants are not capable of pain until the cerebral cortex becomes active between 24-30 weeks of gestation. The co-author of the study was an internationally known pro-choice neuroscientist named Stuart Derbyshire. To this day, pro-abortion activists routinely cite the study to claim that abortion before 24 weeks hurts no one.  

Yet Stuart Derbyshire has firmly recanted his 2010 finding because further research demonstrated that preborn infants can experience pain well before they have a developed cortex.     

His updated scientific conclusion? “Overall, the evidence, and a balanced reading of that evidence, points towards an immediate and unreflective pain experience mediated by the developing function of the nervous system from as early as 12 weeks.”

The discussion about pain is important because of the ramifications for improving our medical care. However, the capacity to be affected by pain is not what determines our humanity. Neither do the circumstances of conception or whether the new baby is wanted.

Derbyshire confronts this inherent contradiction between abortion and science with rare candor. In a recent interview, he said that even though he remains philosophically pro-choice, from a scientific perspective “the discussion about viability is insane … If you are defending abortion and you’re trying to say a fetus is like a rock or a tree, then you are in trouble. It is alive.”

He didn’t stop there. Derbyshire told the interviewer that pro-choice advocates like himself (and Justice Sotomayor) need to face the fact that abortion impacts two humans.

It’s a simple truth. The baby is fully human whether or not he or she can feel pain; the baby is fully human whether or not the mother reports feeling the pain of grief (often they do, even if it is complicated). However, in uncovering the intrinsic pain that abortion inflicts on mother and baby, perhaps we may uncover better ways to nurture the mother-infant dyad.

Being pro-life is more than being pro-birth.  By better caring for both the mother and the baby may their love ignite the embers of hearts grown old and cold beneath the weight of a law that has damaged and destroyed so many.