When it comes to mifepristone, the agency has sacrificed its noble mission by putting politics over science and endangering girls and women.
When it comes to mifepristone, the agency has sacrificed its noble mission by putting politics over science and endangering girls and women.
R egardless of where they stand on abortion, any physician who cares about maternal safety should be alarmed by the Food and Drug Administration’s (FDA) mishandling of the safety protocols surrounding abortion drugs.
Oral arguments will take place today at the Supreme Court in Food and Drug Administration v. Alliance for Hippocratic Medicine. In this case, physicians contend that the FDA failed to meet its legal obligation to protect girls and women when it ignored significant health risks and in 2016 began stripping away maternal-safety protections around mifepristone. The FDA has eliminated its mifepristone safeguards so much that, as of February, girls and women can obtain the drug via mail order after a brief online or telephonic interview with a remote “provider.” This leaves girls and women with no physician oversight, no in-person exam, no ultrasound, and no follow-up visit to ensure completion of the abortion.
My daily work as a radiologist includes the evaluation of expectant mothers in the first ten weeks of pregnancy, the time frame during which the FDA has approved mifepristone for use. I am shocked at the agency’s shoddy and politicized deregulation of this drug. The FDA is tasked with ensuring that the use and distribution of any drug is appropriately tailored to its risk profile. With mifepristone’s significant complication rate (7.9 percent in the original U.S. trials) and serious complications (sepsis, hemorrhage requiring transfusion, death), the FDA implemented a “risk evaluation and mitigation strategy” (REMS) when it approved the drug in 2000. Nothing but a disregard for maternal safety explains the agency’s abandonment of the original REMS in 2016.
These facts compelled me to submit an amicus brief in the case which explains why maternal/fetal ultrasound — my area of expertise — is a crucial part in evaluating a woman seeking a chemical abortion. It also explains how dangerous these drugs are without ultrasound evaluation. It’s a simple procedure, but one that can’t be done when mifepristone is obtained without an in-person doctor visit.
An ultrasound is the only way to reliably determine the age of an embryo. For pregnant women contemplating a chemical abortion, dating the pregnancy is essential. After ten weeks of pregnancy, the threat of severe complications from taking mifepristone rises exponentially. There are three basic methods used to determine gestational age: menstrual history, clinical exam, and ultrasonography. The American College of OB-GYN’s (ACOG) recommends ultrasound as the most accurate method to determine gestation age. If an ultrasound is not performed, “The pregnancy should be considered sub-optimally dated.”
Under the FDA’s deregulation regime, the only method used for most girls and women will be menstrual history. But studies show that anywhere from 10 to 45 percent of women cannot provide an accurate date of their last period. Studies have also shown that even when women say they are certain of their dates, almost 20 percent turn out to be wrong. One peer-reviewed analysis showed that 14.8 percent of expectant mothers underestimate the age of their embryos.
A woman who thinks she is nine weeks pregnant can easily be eleven weeks pregnant, and this has major implications in a chemical-abortion situation. Without ultrasound and physician oversight, she will be prescribed mifepristone based on her mistaken dates, and her fetus will be well beyond the FDA’s ten-week limit, resulting in a far riskier and more traumatic abortion.
The science is clear. The FDA knows these numbers. It has access, as I do, to studies that show that up to 11.8 percent of women who had a chemical abortion were actually ineligible because of advanced fetal age and size. It also knows that if a chemical abortion happened after 84 days of gestation, 38.5 percent of those women required follow-up surgery and 4 percent sustained significant infection. In fact, all the original studies the FDA used to establish the REMS included an ultrasound in the protocol to properly date the pregnancies. By making mifepristone a “do it yourself” proposition, the agency has abandoned its duty to protect the health and safety of girls and women.
In truth, whether they are pro-life or pro-choice, physicians who care for pregnant women should want to maximize their safety. We know mifepristone is not, as is widely and wrongly reported: “safer than Tylenol.” How could it be, if up to 4.6 percent of women have to visit the emergency room after taking it?
I sincerely hope the Supreme Court will demand the FDA fulfill its legal obligation to protect “the public health by ensuring the safety, efficacy, and security” of drugs. When it comes to mifepristone, the agency has sacrificed that noble mission by putting politics over science and endangering girls and women.