The U.S. Food and Drug Administration estimates 5.6 million women in the United States used mifepristone, the first drug in the abortion pill’s two-drug regimen, for abortion between September 2000 and June 2022.

Despite its growing use, the abortion pill’s safety has been repeatedly called into question by pro-life doctors and advocates since the FDA’s approval in 2000 of mifepristone.

On May 17, a U.S. appeals court considered a lawsuit filed in Texas against the FDA, alleging that the agency unnecessarily accelerated mifepristone’s initial approval in 2000 without following usual protocols, and that the FDA also incrementally removed safeguards for the regimen’s use without sufficient evidence to support the deregulation.

While abortion advocates have praised the lowering of restrictions around the drug in the name of access, pro-life advocates say that has come at the expense of women taking the drug.

“The health and safety of women has just been thrown out the door to allow for online, no test distribution,” said Kristi Hamrick, chief media and policy strategist for Students for Life of America, which runs the website thisischemicalabortion.com and has fought against expanding the abortion pill’s distribution on college campuses.

Mifepristone — also known as RU-486 or under the brand Mifeprex — works by blocking the hormone progesterone, which the preborn child needs to live. Misoprostol, also known under the brand name Cytotec, induces contractions to expel the aborted baby. Pro-life advocates refer to the process as “chemical abortion” because they say “medication abortion” — the term often used by abortion proponents — connotes health.

For the first two decades following mifepristone’s FDA approval, prescriptions for the abortion pill required the first drug to be administered at a medical clinic. Medical professionals needed to confirm the pregnancy and determine that the pregnancy was not ectopic — where the fertilized egg grows outside of the uterus, and, if undetected, is deadly to the mother — or that the baby’s gestational age had not exceeded the drug’s approved timeframe.

When the FDA first approved Mifeprex, it was authorized for the first seven weeks of pregnancy. In 2016, the FDA expanded its use to the first 10 weeks of pregnancy. Studies show that the risk for complications increases the further along the pregnancy is.

In 2021, the FDA announced it was permanently allowing the abortion pill to be obtained by mail, rather than through an in-person visit to a clinic — a requirement it first lifted temporarily during the COVID-19 pandemic. In January, the FDA changed regulations to allow drugstores to fill prescriptions for mifepristone. The changes have made it possible for women to obtain a prescription for the abortion pill without having been physically evaluated to determine how old the baby is, screened for risk factors, or evaluated for signs of trafficking, abuse or coercion.

Last year’s U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization returned abortion policy to state lawmakers, creating a patchwork of abortion laws across the country. Between April and December 2022, abortion pills obtained through telehealth visits with virtual-only clinics increased by 136% — from 3,610 to 8,540, increasing each month — according to an April 2023 report from the Society of Family Planning, an organization which studies abortion trends.

Abortion activists view telehealth as a means to get the abortion pill to women in states where abortion is restricted or outlawed, or where contested laws made its future legality uncertain.

In November, the pro-life organization Alliance for Hippocratic Medicine filed a lawsuit in Texas alleging that the FDA caved to political pressure and violated its own safety standards by fast-tracking its 2000 approval of mifepristone, and it has not sufficiently studied complications associated with mifepristone to support its initial approval or subsequent reduction of safety protocols. The complaint also alleged that the FDA was in violation of the Comstock Act, which prohibits the mailing of abortion drugs.

In April 7, a U.S. district judge in Amarillo ruled in favor of the plaintiffs and issued a stay on mifepristone, effectively suspending the FDA’s approval of the drug. Shortly after, a U.S. district judge in Washington state filed a conflicting ruling aiming to block the FDA from “altering the status quo” for mifepristone. A week later, a three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans ruled to temporarily block the drug’s total suspension, but restored the restrictions present with the drug’s initial approval in 2000.

On April 21, the U.S. Supreme Court granted a request from the Justice Department and Danco Laboratories, whose sole product is Mifeprex, to block the stay, allowing mifepristone’s current use as the case moves through the 5th Circuit. The court heard arguments in the case May 17.

The FDA states that as of June 2022, there had been 28 reports of death associated with, but not necessarily caused by, mifepristone, since its September 2000 approval. Other associated complications include hospitalization, blood loss requiring transfusion and infections. The drug carries a “black box warning” — the FDA’s strongest warning for drugs with major risks — and a Risk Evaluation and Mitigation Strategy, or REMS, which the FDA describes as “a drug safety program … for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”

However, Plan C, a website Planned Parenthood supplies as a resource to help women obtain the abortion pill by mail, calls them “very safe” and focuses on potential legal risks over health risks when advising women how to obtain the abortion pill. The Plan C website includes scenarios where women have “gotten in legal trouble” for going to urgent care, where “my doctor reported me to the police,” or cases where trusted family or friends “reported” them. It also says people can buy pills now to use later, “just in case,” a practice pro-life advocates say is rife with potential abuse by traffickers and abusers. The drugs reportedly cost from $40 to $600 or more.

As some states have expanded the availability of the abortion pill, they also have sought to eliminate the availability of abortion pill reversal, where mifepristone’s effects are reversed prior to the dose of misoprostol through a strong dose of progesterone. The practice is controversial, but doctors who use it say it has helped women save their babies. A Colorado ban on the treatment is moving through the courts.

Dr. Ingrid Skop, a board-certified OB-GYN and vice president and director of medical affairs for Charlotte Lozier Institute, the research arm of the pro-life organization SBA Pro-Life America, said she is grateful for the media attention drawn to the Alliance for Hippocratic Medicine’s lawsuit. Charlotte Lozier filed an amicus brief in the Texas lawsuit. The complaint includes Skop as a declarant, in which she describes her experience caring for women who had complications due to chemical abortion.

The lawsuit raises awareness about chemical abortion and provides an opportunity to draw attention to its widespread use and risks, she said, as well as dispels misunderstandings, such as that it’s the same as Plan B — also known as the morning-after pill or “emergency contraception” — an abortion-inducing drug taken within days of having sex, not weeks into a pregnancy.

And while she hopes that the lawsuit will lead to FDA oversight, force the agency to further study mifepristone, reinstate the drug’s initial 2000 regulations and institute a federal mandate for abortion reporting, she said she’s not advocating for mifepristone to be taken off the market entirely. If that happens, she is concerned that chemical abortion providers will turn to misoprostol-only methods, which induce labor without first killing the baby.

“No. 1 is to really get people thinking about what is abortion,” Skop said. “Does it help women, and if a woman is going to have an abortion, should we give her one that’s more dangerous, as opposed to a surgical abortion?”