FDA on the Docket at Supreme Court: What to Know Ahead of Abortion-Pill Case

The March 26 hearing before the Supreme Court will mark the first time the high court has considered a major case on abortion since Dobbs in 2022.

By Judy Roberts, originally published March 14, 2024, National Catholic Register

Abortion advocates like to say their fight for the right to terminate life in the womb is simply about “women’s health,” but that assertion is being challenged by a case going before the U.S. Supreme Court March 26.

At stake in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration is the federal lifting, in 2016 and 2021, of restrictions by the Food and Drug Administration (FDA) on use of the chemical abortion pill mifepristone, making it easier to obtain.

In a case originally brought by a group of medical associations and doctors challenging both the drug and the eased restrictions, the U.S. 5th Circuit Court of Appeals ruled in August that the approval of the drug can stand, but the FDA must reinstate the restrictions. The Biden administration has appealed that decision to the Supreme Court. This will mark the first time the high court has considered a major case on abortion since overturning the constitutional right to an abortion in 2022.

The Alliance for Hippocratic Medicine, a group that includes the American Association of Pro-Life Obstetricians and Gynecologists and the Catholic Medical Association, has argued that eliminating the restrictions has endangered the health of women who take mifepristone as part of a two-drug regimen. Mifepristone, which blocks nutrition to the baby, is taken first and is followed by a second drug, misoprostol, which induces uterine contractions.

In approving the regimen for use in 2000, the FDA had said mifepristone could not be safely used without certain measures, including limiting its administration to women with pregnancies at seven weeks or less. Additionally, only doctors able to diagnose ectopic pregnancies and determine gestational age could prescribe the regimen. Doctors also had to administer the first and second drugs in person and see patients for follow-up visits on the 14th day to check for complications.

Those restrictions were changed in 2016, when the FDA eliminated in-person visits to administer the second drug on the third day and to check the patient on the 14th day and increased the gestational age at which the drugs could be administered from seven to 10 weeks. At the same time, the FDA said prescribers no longer had to be physicians.

The restrictions were further relaxed in April 2021, when the FDA, citing the COVID-19 pandemic, allowed mifepristone to be dispensed by mail, and in December 2021, when the initial in-person visit was eliminated as a requirement. Women now can be prescribed the abortion pill via a virtual appointment.

Dramatic Increase in Complications

Erik Baptist, senior counsel for Alliance Defending Freedom, which is representing the Alliance for Hippocratic Medicine and four physicians in the Supreme Court case, said with the lifting of restrictions, his clients have treated many women who have suffered complications from taking the abortion drugs.

“Our doctors have testified that they have seen a dramatic increase in the number of women presenting complications since the FDA’s removal of the follow-up, in-person doctor visits in 2016 and the elimination of the [initial] in-person visit in 2021,” Baptist said, adding that these changes have left women who take the abortion drugs without any ongoing care by a doctor. “There is no in-person office visit to check them before taking the drug and no follow-up care afterwards to screen for complications.”

The doctors represented by ADF, Baptist said, include obstetricians, emergency-room physicians and hospitalists. All have been affected by what he called the reckless removal of abortion-drug restrictions because the FDA itself has directed women to go to emergency rooms for complications related to taking the drugs.

“The FDA’s own label,” Baptist said, “estimates that 1 in 25 women will end up in the ER.”

He told the Register, “Our doctors will never turn away patients with life-threatening conditions, but they also care about the patients and don’t want them in this situation in the first place. Because of the FDA’s reckless action, women are suffering unnecessarily.”

Putting More Women at Risk

Dr. Donna Harrison, director of research for the American Association of Pro-Life Obstetricians and Gynecologists and an associate scholar with the Charlotte Lozier Institute, concurred. She said the changes in restrictions by the FDA put women more at risk for complications, some of which are life-threatening.

“This isn’t about women’s health,” she said. “The FDA will have to say why they are recklessly endangering women with a dangerous drug. This is not about making life better for women. It is making life more dangerous for women.”

Harrison said she is concerned about the elimination of the in-person visits because they can help ensure that a patient is not being coerced or a victim of sex trafficking. And medically speaking, she said, they are the only way in which a health-care provider, using ultrasound, can screen for an ectopic pregnancy (one that is implanted outside the womb) or accurately determine the length of gestation. This is important, she said, because giving mifepristone to a woman with an ectopic pregnancy or one who is past 10 weeks in her pregnancy can be dangerous.

Ultrasound Critical in Protecting Women

Dr. Grazie Pozo Christie, who has filed an amicus brief with The Catholic Association in the Supreme Court case, agreed.

“As a practicing radiologist specializing in diagnostic radiology,” she told the Register, “I see every day how critical ultrasound is in protecting women.”

Although a fetal ultrasound is not a requirement for prescribing mifepristone, when a physician attends a patient personally, Christie said, one often is done as a natural part of the exam. By eliminating the in-person visit, the FDA in effect has taken away the only reliable method of determining the age of the embryo or fetus.

“That is unconscionable,” she said, “because women very often are wrong about how pregnant they are. In my own personal experience, one of the reasons we perform ultrasounds is to date the pregnancy. More often than not, women don’t know how long they’ve been pregnant. And if they’re off by a couple weeks, the complication rate shoots through the roof with chemical abortions.”

Just last week, Christie said, she saw a patient who thought she was seven weeks’ pregnant based on the date of her last cycle. Her baby’s actual gestation was 13 weeks.

Christie also is troubled by the FDA’s removal of the in-person follow-up visit, during which a doctor would make certain that the chemical abortion was complete, and nothing remained in the uterus. If the uterus is not evacuated, the patient can experience bleeding and cramping, which could lead to hemorrhaging, infection, sepsis and even death.

“By eliminating the follow-up visit,” Christie said, “… the woman ends up in the emergency room and has to be followed there. It’s not fair to her to have a Wild West approach to something so serious. It’s like we’re back to the back alley.”

Catholic Concerns

Christie’s amicus brief also points out that the reliance on emergency-room care brought about by the FDA’s deregulation of mifepristone “means that Catholic hospitals and Catholic emergency-room doctors, nurses and other health-care providers can be conscripted into completing attempted abortions, or otherwise participating in medical treatment that facilitates an abortion, in violation of their conscience.”

Harrison added that another factor to be considered is that a woman cannot give her informed consent to treatment with mifepristone without an accurate determination of the length of her baby’s gestation. “Unless you know how far along she is in the pregnancy, you can’t tell her the risks.”

This issue has been raised by the U.S. Conference of Catholic Bishops and 10 other groups in another amicus brief filed in the case.

Under the current FDA protocols for mifepristone, the brief states, the fundamental principles of informed consent, which protect both patients and medical professionals, cannot be met. These include basing the patient’s decision on adequate disclosure of the diagnosis, the proposed treatment and its benefits, risks and alternatives in addition to the patient’s capacity and freedom from coercion.

The brief goes on to say that the in-person visits eliminated by the FDA are critical to adequate diagnosis and informing a woman of her risks related to mifepristone: “Women can only benefit from more information and more protection, especially when considering whether to take a drug that FDA acknowledges is dangerous and that has permanent consequences.”

As the National Association of Catholic Nurses, USA stated in the brief they joined with the bishops and other groups, Catholic nurses remain “critically concerned” “for the well-being of women and their unborn children threatened by the FDA-approved protocol for prescribing and dispensing mifepristone.”

Although Christie said she wishes chemical abortions were never practiced and continues to do what she can to promote the dignity of life, she sees the loosening of restrictions on them as a different injustice because they are putting women at great risk. “As long as chemical abortions exist — and I wish they didn’t — I would like them to be safe for women.”

Judy Roberts is a journalist who has worked for both the secular and Catholic press. In addition to the Register, she has written for Legatus Magazine, Franciscan Way and Our Sunday Visitor, and is a former religious books reviewer for Publishers Weekly. She also blogs about living more serenely in a busy world at quietkeepers.com.