The legal battle over the abortion pill, the most common abortion method in the country, is the new frontier of pro-life and pro-abortion advocacy in a post-Roe world.  

With pro-life laws banning abortion having taken effect in 13 states in the wake of the U.S. Supreme Court’s Dobbs decision overturning Roe v. Wade, abortion advocates are pushing for the broad deregulation of access to medication abortion to undermine these laws. 

But while the Biden administration recently framed the chemical-abortion regimen for women as “medication that they need,” pro-life doctors have continued to sound the alarm over health and safety concerns that they say have been ignored amid the push for greater access to abortion. And now, one judge in Texas could block access to the abortion pill in the Alliance for Hippocratic Medicine v. FDA case, where groups have filed suit alleging that the U.S. Food and Drug Administration disregarded safety concerns and protocols in approving and deregulating the abortion pill mifepristone.

Medication abortions, performed by taking the abortifacient drug mifepristone along with another drug called misoprostol, accounted for 53% of abortions in the U.S. in 2020, according to the Guttmacher Institute. Following last year’s Dobbs decision, medication abortions are likely even more widespread. The New York Times recently noted that around 40% of the nation’s abortion facilities only provide medication abortions. 

While the abortion industry, and the White House, backs these pills as needed health care that, they claim, is “safer than Tylenol,” the case before Texas Judge Matthew Kacsmaryk highlights the FDA’s fast-tracked approval process, significant safety concerns, and the failure to track complications. 

Erik Baptist, senior counsel at Alliance Defending Freedom (ADF), told the Register that the abortion pill’s approval was a politicized process that skipped important safeguards. ADF filed the Texas lawsuit against the FDA on behalf of several pro-life physicians and medical organizations, including the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists and the American College of Pediatricians.

 

Approval History

Baptist pointed out a portion of his organization’s lawsuit, noting that in order to approve the abortion-pill regimen in the U.S. in 2000, the Clinton administration pressured “the French manufacturer of the key chemical abortion drug, mifepristone (also known as ‘RU486’ and ‘Mifeprex’), to donate for free the U.S. patent rights of the drug to the Population Council — as its name suggests, an entity focused on population control”; the council then “submitted a new drug application, worked closely with the Clinton FDA during the review process, and, not surprisingly, obtained the agency’s approval.”

The approval was obtained through Subpart H, Baptist noted, which applies to “new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” The Population Council initially opposed this method of approval, stating in a letter to the FDA that “[n]either pregnancy nor unwanted pregnancy is an illness, and Subpart H is therefore inapplicable for that reason alone.” The Population Council eventually withdrew their opposition, and the drugs were approved in that way.

Baptist said that the FDA “was also required to have studies that actually evaluated the real-world use of these drugs as directed by the label,” but the agency “has never done that.” Additionally, the suit contends that the agency ignored “the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls in violation of the Pediatric Research and Equity Act (PREA),” despite approving its use for girls under 18 years of age.

Carolyn McDonnell, litigation counsel at Americans United for Life, told the Register that the FDA is required to have “sufficient studies of a drug’s safety and efficacy before they can approve that new drug for use”; and in the case of the abortion pills, “the FDA did not have sufficient data when they were approving these drugs.”

She pointed out that then-FDA Commissioner Jane Henney testified before Congress in February 2000, as the drugs were nearing their final approval, that “the primary clinical trials conducted by the sponsor to support the safety and efficacy of mifepristone” did “not include an evaluation of the psychological effects of the drug in women or an evaluation of the long-term medical consequences of the drug in women. FDA is unaware of any published studies on the psychological effects or the long-term medical consequences of mifepristone in women.” 

McDonnell believed that the judge is likely to issue a preliminary injunction against the abortion pill in the coming weeks, and it’s also likely that the Supreme Court will eventually hear the case, as the Biden FDA is poised to appeal such a move. 

 

Deregulating Abortion Pills After Roe

McDonnell said that since Dobbs overturned Roe and “there is no federal statute that protects abortion as a right,” the Biden administration “has turned to the administrative agency level, and they’re trying to rewrite statutes and trying to create this abortion right within administrative regulations.” She sees the administration’s attempts to deregulate chemical abortion pills as part of this, calling it “one of the new battlegrounds of our post-Roe world.”

Baptist said the Biden administration’s December 2021 removal of the in-person dispensing requirement for the abortion pill is “dangerous on many fronts.” Without seeing the woman in person, he said, a doctor is unable to confirm the woman’s child’s gestational age or screen for a potentially life-threatening ectopic pregnancy. 

Physicians like Dr. Ingrid Skop, a Texas OB-GYN and director of Medical Affairs at the Charlotte Lozier Institute, have noticed significant complications due to these pills. She said that one of the reasons she became involved in speaking out against chemical abortions was due to the fact that, in her 30 years as an OB-GYN, she has cared “for women who come into the emergency room with complications,” and it made her question why she was “seeing these complications when they say they’re so rare.”

She emphasized that the United States does not have any “system that tries hard to collect complications” from chemical abortions. She highlighted a study from the Charlotte Lozier Institute, which gathered data from the 17 states that use Medicaid to pay for abortion and was able to link women who had chemical abortions with subsequent complications. The study found that “about 5% of women presented to an emergency room within a month of the chemical abortion with a complication from the abortion,” and, “60% of the time, those complications were miscoded as due to a miscarriage.” 

Added Skop, “Other studies tell us that complications are four times as high with a chemical abortion compared to a surgical abortion.’” 

Skop said that by removing the requirement for a woman to have an in-person visit beforehand, the Biden administration is exposing women to additional dangers and complications. Without an exam to confirm the gestational age of the unborn baby, “if the pregnancy is maybe a month further along than the woman thinks it is, her complications are higher.” She added that an undetected ectopic pregnancy “can lead to catastrophic hemorrhage,” and “some women have died from ruptured ectopic pregnancies when they thought they were having a chemical abortion.”

The FDA itself acknowledged some of these concerns, in relation to the question of allowing the advance provision of the abortion pill in cases where the woman is not yet pregnant. The FDA told Politico in October that in such cases, “a medical professional may not be able to assess if a pregnancy is intrauterine or ectopic or date pregnancies properly” when the woman does take the abortion pill. The FDA did not respond at the time to a question from the Register regarding why those same concerns wouldn’t apply to any medication abortion without an in-person doctor’s visit.

Skop also noted that “not being sure who’s ordering the pill” means that abusers and coercive boyfriends can obtain it and can do so even more readily now that the Biden administration recently allowed its distribution through pharmacies. 

Skop has seen the abortion industry rely increasingly on abortion pills due to pro-life laws in various states as well as the ongoing shortage of doctors who are willing to perform abortions. “This has been a way for the abortion industry to solve its staffing problem and to save money,” she said. “It’s more lucrative to sell pills than it is to provide surgical services; pay a surgeon; pay for the equipment and sterilization.” 

“They did see on the horizon that Roe might be overturned,” she added. “I think that that was part of the plan to be able to get into states like Texas.” She said that “despite the fact that Texas has a total abortion restriction,” she still sees “women who come into the emergency room with complications” from the abortion pill.

 

Pro-Life State Battles  

Red and blue states have entered into legal battles on both sides of the abortion-pill issue. Following the FDA’s recent announcement that certified pharmacies could distribute the abortion pill, Walgreens announced that it will not distribute the abortion pill in 20 states where the Republican attorneys general wrote a letter warning, “Federal law expressly prohibits using the mail to send or receive any drug that will ‘be used or applied for producing abortion.’” These states disagree with the Biden administration’s interpretation of the law permitting mail-order abortions, arguing that it also violates state law and would not hold up in court.

In contrast, a group of a dozen Democratic attorneys general recently sued the FDA, asking the FDA to remove all remaining restrictions on mifepristone. They accused the FDA of obstructing abortion access by “singling out mifepristone — and the people in the Plaintiff States who rely on it for their reproductive health care — for a unique set of restrictions” that are “burdensome.”  

An example they gave of a burdensome regulation included “documentation of the patient’s use of mifepristone for the purpose of abortion, making telehealth less accessible and creating a paper trail that puts both patients and providers in danger of violence, harassment, and threats of liability amid the growing criminalization and outlawing of abortion in other states.” They claimed that complications from the drug are “exceedingly rare.” 

Rebecca Parma, senior legislative associate at Texas Right to Life, told the Register that while the abortion pill has been around for a while, “in the past couple of years, it’s become the main method by which abortions are performed in our country and in Texas as well.” Following pro-life laws in Texas that have made abortion, including abortion by pills, illegal, the pro-life group has seen “the abortion industry pivoting to pills because they are more accessible. They are accessible via the internet. They are accessible by being trafficked across the border.” Abortion pills “are certainly the new focus of our movement and it seems of the abortion industry as well,” she said.

Parma sees the Alliance for Hippocratic Medicine v. FDA case as having the potential to end up before the Supreme Court and hopefully spur necessary conversations about chemical abortions. She described the fight to regulate abortion pills as a new frontier, saying that “the way that the FDA approved the drugs is not in line with how they normally do so, especially when we’re considering such a dangerous drug that has so many ramifications and complications for women.”