When mifepristone and misoprostol were first approved in 2000, the Food and Drug Administration (FDA) failed to adequately review its safety during the drug approval process. In fact, the only way the FDA was able to skip the normal approval process was by classifying pregnancy as a “life-threatening illness.” This is absurd.
Even more concerning is that the FDA unlawfully waived the pediatric study it is required to do, meaning this drug regimen was never tested on girls under the age of eighteen. Pediatric studies are important for many reasons. In this case, a drug that affects hormones might respond differently in a teenager going through puberty than in an adult woman. However, no one knows how differently these potent drugs may affect adolescent girls’ development because the FDA skipped the required studies.
Concerns surrounding the use of mifepristone and misoprostol aren’t new. Take for instance the story of 18-year-old Holly Patterson, who died from septic shock just days after having a chemical abortion at a Planned Parenthood in California. This young woman’s death was preventable, but because her symptoms were not recognized she was initially brushed off with more painkillers and sent home. In response to this tragedy, a “black box” warning was added to mifepristone’s and misoprostol’s labeling.
In addition, misdiagnosis is a serious problem that increases the risk to pregnant women. Underestimation of gestational age will result in a higher likelihood of failures requiring surgery. A woman with an undiagnosed ectopic pregnancy, for example, is 30% more likely to die from a ruptured ectopic while undergoing a chemical abortion than if she had not sought an abortion. This is because she may attribute pain and bleeding to the abortion rather than a warning sign that her life is in danger.
That’s why the Biden administration’s attempt to weaken the safety protocols surrounding these drugs is such a big deal. Under previous guidelines, this drug could only be dispensed in an in-person healthcare setting. Yet the Biden administration removed that safeguard by approving “DIY” abortions by mail.
Why is the medical bureaucracy putting its weight behind mail-order abortions? The answer isn’t science or public health; it’s politics. Since the Supreme Court struck down Roe v. Wade, more states are passing pro-life legislation. To get around these laws, activist bureaucrats want to send these dangerous drugs through the mail and are risking women’s health in the process. But politics is no excuse for neglecting proper vetting processes for a pharmaceutical drug.
According to federal data, the rate of abortion pill-related emergency room visits has increased 500% since mifepristone and misoprostol were approved. One major study showed abortion drugs are four times riskier than surgical abortions. One in five women suffered complications, 15.6 percent suffered hemorrhage, and 5.9% required surgery, often in emergent conditions, after taking abortion pills.
Part of the problem could be that these pills were only tested in-person; therefore, there is no data regarding the safety for those taking them at home without medical supervision. As an OB-GYN who has practiced medicine in Texas for 30 years, I (Dr. Skop) have treated multiple women who have suffered complications from taking abortion pills, including recently performing an emergency surgery on a woman who bled for months after having a chemical abortion.
Doctors take an oath to do no harm. This pill is harming not just unborn babies, but women and girls as well—and under the current administration, starting with the excuse of COVID-19, it has been ordered online and mailed regardless of the consequences.
No Biden administration official or FDA paper pusher is in the emergency room when women come in with complications from this drug, but physicians are. And we are concerned. That’s why a group of doctors sued the FDA over its lax abortion pill rules.
According to the FDA, as of June 2022, 4,213 women experienced adverse effects from mifepristone and misoprostol, 1,048 were hospitalized, 604 lost so much blood they needed transfusions, and 141 contracted infections—71 of which were considered severe.
Yet the use of this drug has increased over the past ten years by 120 percent. Unfortunately, we may never know how many women are actually harmed by this drug as there are no mandatory reporting requirements, and some doctors have pledged not to report this critical public health data to the federal government. Since 2016, the FDA has tracked no complications short of death—a fact that undermines Americans’ confidence and trust in its authority.
The FDA’s decision to ignore the facts is negligent. The Fifth Circuit agreed. Pending Supreme Court review, this decision is a vindication of the alarms we doctors have been raising about our patients’ safety.
The abortion lobby’s go-to argument for decades has been that abortion is health care and it is “between a woman and her doctor,” but fast-tracking an untested drug and putting it in the mail without a doctor’s supervision undermines their own argument. In reality, many on the far-left care less about women’s health than they do about pushing abortion-on-demand, without apology.
It’s our duty to ensure women and girls are safe. The FDA has failed to meet its legal obligation. It’s clear: the FDA put politics above the health and safety of women. This cannot stand—accountability is long overdue.
Rep. Mark Green is a physician and combat veteran of Afghanistan and Iraq, where he served three tours. He interviewed Saddam Hussein for six hours on the night of his capture. He is chair of the House Homeland Security Committee and serves on the Foreign Affairs Committee.
Ingrid Skop, M.D., FACOG, is Vice President and Director of Medical Affairs for Charlotte Lozier Institute, leveraging more than 30 years’ experience as a practicing obstetrician-gynecologist in Texas. Read the full article here.