On Thursday the Food and Drug Administration (FDA) announced that drugs causing abortion will be available to women without an in-person visit.
In a Q&A section, the FDA noted, without citing or linking the review that "[a]fter conducting a review of the single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, known as the Mifepristone REMS Program, FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks."
While the FDA approved a regimen of mifepristone and misoprostol for this method in 2000 up to 7 weeks, and extended it to 10 weeks in 2016, REMS, from 2011, had gotten considerable attention since the pandemic.
Abortion advocates sued to get the in-person visit requirement removed, which a judge granted. While the Trump administration defended the requirement, and it was ultimately upheld by the U.S. Supreme Court in January, the Biden administration removed it in April, a move that was temporary until it became permanent on Thursday.
The method is already a dangerous one, more so than surgical abortions, though those carry with them their own risks, especially as a woman gets farther along in her pregnancy.
A woman first takes mifepristone, which starves her unborn child of nutrients. Then, 24-48 hours later, she takes misoprostol to cause contractions to expel the dead child.
This method carries with it four times the complications of surgical abortions. Side effects and risks associated with this method include abdominal pain, nausea, vomiting, diarrhea, weakness, fever/chills, and headaches. The bleeding may last for weeks after the abortion.
Some studies have found 10 percent of women face incomplete abortions at 9 weeks gestation. This can lead to death from infection if the remaining fetal parts or tissue are not properly removed.
Last month, as I covered, the Charlotte Lozier Institute (CLI) authored a study that showed emergency room visits following this method went up by 507 percent from 2002 to 2015. Most of these ER visits, over 60 percent, were miscoded as spontaneous miscarriages.
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CLI was quick to call out the Biden administration for such a move on Thursday.
Tessa Longgbons, senior research associate at CLI, indicated that "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."
"What’s also clear today is the Biden FDA is cherry-picking flawed data to give the abortion industry a Christmas gift. They could call Medicaid and get the same publicly-available data that Lozier Institute scholars studied showing that chemical abortion has led to a surge in emergency room visits. Instead, they increased the risk to women’s health," said CLI's Executive Director Stephen Billy.
In-person visits would enable doctors to confirm that a woman is indeed pregnant, is under the 10 week limit, and is not facing an ectopic pregnancy. The chemical abortion method will not terminate an ectopic pregnancy, which is surgically removed and is not considered abortion as the pregnancy is not viable and will injure or kill the pregnant woman.
In procuring the drugs by mail or online, a woman may not be sure of the safety or authenticity of the drugs. Without an exam, she may not know if she is under the gestational limit or is not experiencing an ectopic pregnancy.
Not only are these methods more dangerous, they've also become more common. The number of abortions increased in 2019, the most recent data available from the Centers for Disease Control (CDC) showed. Chemical abortions accounted for 42.3 percent of all abortions, according to that data released last month.
It's worth noting that California, the most populous state with some of the most relaxed abortion laws, including when it comes to this method, does not report its abortion numbers.
Rep. Chip Roy (R-TX) in July sponsored legislation to combat a state law signed by Gov. Gavin Newsom (D-CA) that requires public universities in California to dispense these drugs to college students free of charge. Such a bill will defund these institutions.
The office of Sen. Steve Daines (R-MT), who sponsored a version in the Senate and is the founder of the Senate Pro-Life Caucus, provided a quote from the senator.
"The Biden administration’s move to make dangerous do-it-yourself abortions by mail available without any medical oversight is alarming and reckless. It is yet another attempt by this Administration to impose an extreme abortion agenda that prioritizes the abortion industry’s greed at the expense of innocent lives and women’s safety,” Daines stated.
Other pro-life organizations also chimed in.
Lila Rose, founder and president of Live Action also warned about the move. "The trauma of an at-home abortion not only destroys the life of a preborn child and all her limitless potential, but also puts her mother at grave medical risk. Because of the FDA’s unscientific and dangerous decision today, our own U.S. Postal Service will continue to be a lethal pipeline for both women and their children," she said.
"We always knew that the Biden Administration was full of abortion extremists with no regard for a preborn baby, but we hoped that they wanted women at least to survive an abortion. The FDA’s change in the health and safety standards for Chemical Abortion Pills places women at great risk of injury, infertility, and even death, which doesn’t seem to bother the self-proclaimed ‘women’s advocates’ working for Joe Biden," said Students for Life Action President Kristan Hawkins. "This reckless change helps abortion vendors make a fast buck but does nothing to help women who may want to survive an abortion with her life and fertility intact."
Students for Life Action has been speaking out against the method with a particular passion, from legislative efforts as well as putting together the "This is Chemical Abortion" website highlighting the dangers.
Robert Califf, who previously served as the FDA commissioner under Barack Obama, is currently under consideration to return to that role.
Thank you @SenatorBraun for asking FDA Commissioner nominee Robert Califf if he will follow the latest data and science to protect women and girls from the risks of dangerous chemical abortion drugs pic.twitter.com/iVwJrg2JFf
— Susan B. Anthony List #ModernizeOurLaw (@SBAList) December 14, 2021
Sen. Mike Braun (R-IN) during a Tuesday hearing asked Califf if he would follow the latest data and science on this issue. While Califf indicated he is not involved in this reevaluation, he claimed to "assure" the senator that "the staff will be looking at the latest data and applying the best science and make the best possible decision."
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