Deaths of two pregnant women in Georgia reopens debate about safety of abortion pills

The Food and Drug Administration, which approved the abortion pill in 2000, has been chipping away at regulatory restrictions and eliminating medical safeguards, such as requiring doctors to issue prescriptions in person and follow up with patients afterward.

After an explosive report about two Georgia women who died after taking the abortion drugs in 2022, pro-life advocates are again accusing the agency of going too far.

“The FDA needs to be held accountable for these reckless changes that they made that are allowing these kinds of things to happen,” said Dr. Christina Francis, CEO of the American Association of Pro-Life Obstetricians and Gynecologists.

Three months after the Supreme Court dismissed a challenge to the FDA’s approval of mifepristone, one of two drugs in the abortion pill process, the report has reignited debate about the regimen’s risks.

Candi Miller, 41, and Amber Thurman, 28, died from complications after the self-administered drugs failed to expel all the fetal tissue from their aborted pregnancies, according to a two-part series published last week by ProPublica.

Both needed a routine procedure known as dilation and curettage, or D&C, to remove the tissue. Doctors waited until it was too late to perform the procedure on Thurman, who died during surgery. Miller died at home after refusing to go to a hospital.

Dr. Ingrid Skop, vice president and director of medical affairs for the pro-life Charlotte Lozier Institute, said the women’s deaths “demonstrate conclusively how dangerous medically unsupervised, ‘self-managed’ abortion drugs are, as we have been warning for years.”

“Yet, the FDA has steadily removed important safeguards on these drugs, allowing them to be ordered online and delivered in the mail without a single in-person doctor visit,” Dr. Skop told The Washington Times. “Both women suffered failed abortions requiring surgical treatment.”

Their deaths became a campaign issue after Vice President Kamala Harris cited the report to attack state abortion restrictions. They also raised alarm about the safety of the drugs, which now account for 63% of U.S. abortions.

Planned Parenthood, the nation’s largest abortion provider, called the two-pill abortion process “very safe” and said severe problems are rare.

“This FDA-approved medication abortion process has a 95% effective rate and has maintained a consistent safety record for nearly 25 years,” the National Women’s Law Center said in March. “Leading medical and scientific organizations recognize it as safe and effective, including the American Medical Association and the American College of Obstetricians and Gynecologists.”

The Lozier Institute countered that the pills have a complication rate four times higher than surgical abortions. It cited studies showing that as many as 15% of women will experience hemorrhaging and 2% will acquire an infection.

As the number of women using abortion pills increases, more are turning up in emergency rooms. The number of abortion-related ER visits jumped by 500% from 2002 to 2015, according to the institute.

The ProPublica report pinned the blame for the women’s deaths on Georgia’s heartbeat law, which bans most abortions after six weeks of gestation. It accused the state of making D&C procedures a “felony, with few exceptions,” but pro-life groups were having none of it.

Live Action called the allegation “demonstrably false.” The D&C procedure is commonly used to clear out remaining fetal tissue from the uterus after miscarriages and retained placenta after live births, as well as for surgical abortions.

The Georgia law that took effect in 2022 bans abortions after about six weeks of gestation with several exceptions, including in cases of “medical emergency” to prevent the death of the mother or “substantial and irreversible” physical harm.

“The laws are clear: No state law, including Georgia’s, prevents a hospital from treating a woman in a medical emergency,” said Susan B. Anthony Pro-Life America. “A D&C to remove an unborn child that has died, or dead pregnancy tissue, is not an abortion (let alone a ’felony’ or ‘criminalized’) in Georgia or anywhere.”

ProPublica said the women’s deaths were deemed preventable. Pro-life advocates agree, although not for the same reasons.

Eight years ago, women seeking prescriptions for the two pills in the abortion regimen — mifepristone and misoprostol—would have been required under the FDA protocol to visit a medical doctor three times, including once after taking the drugs to check for complications.

In 2016, the agency extended the gestational age from seven to 10 weeks, allowed professionals without medical degrees to prescribe the pills and reduced the number of in-person visits from three to one.

The agency temporarily eliminated the requirement for an in-person visit in 2021, during pandemic lockdowns, and made the change permanent in 2023. Thus, the pills could be prescribed via telehealth and dispensed by mail.

Miller, who suffered from lupus, diabetes and hypertension, was able to order the drugs online with no in-person medical oversight. Despite experiencing intense pain after taking the pills, she refused to see a doctor because of fears about the Georgia law, ProPublica said.

Dr. Skop said Miller had no reason to fear the measure and accused pro-choice groups of scaremongering. “Misinformation is to blame for these women’s tragic deaths, not pro-life state laws,” she said.

“Candi’s family states she did not seek medical care because she was worried about prosecution, but every pro-life state law prohibits prosecution of women for seeking an abortion,” Dr. Skop said. “Intentional misinformation by pro-abortion media regarding criminal penalties and claims that abortion drugs are ‘safer than Tylenol’ frighten women so that they do not seek medical care when they suffer complications like severe pain and heavy bleeding.”

Thurman drove four hours to North Carolina to obtain her prescription. About a week later, she was taken by ambulance to a local emergency room after she vomited blood and passed out at home. Doctors waited 20 hours to operate.

ProPublica suggested that doctors feared running afoul of the Georgia law, although the article acknowledged that it was “not clear from the records available why doctors waited to provide a D&C to Thurman.”

The FDA has long stood by the safety of mifepristone, sold under the brand name Mifeprex, for use in at-home pregnancy termination. It says the regimen is “safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy.”

“The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation,” the agency said on its website.

At the same time, the FDA said it “does not recommend buying mifepristone online.” The agency does not have regulatory authority over prescription medication outside the country.

The FDA label for mifepristone says 1 in 25 women will need treatment at an emergency room. The drug carries a “black box” warning for potentially deadly sepsis.

Despite the safety concerns, the Supreme Court ruled in June against the Alliance for Hippocratic Medicine’s challenge to the FDA’s approval of mifepristone, saying the pro-life doctors lacked legal standing.

On the other hand, the families of Thurman and Miller may well have standing to sue over the safety of abortion pills, given that they suffered direct injury.

“I absolutely think the families of these women would have standing. Even women who are still alive but were harmed by these drugs have standing,” Dr. Francis said. “I would certainly hope that maybe there would be some women who would hear about these tragedies, or the families who have lost someone, and would realize their family member could still be here today were it not for those drugs. I think it’s time people really understand the truth.”