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."
Ryan Foley is a reporter for The Christian Post. He can be reached at: firstname.lastname@example.org