Pro-Life Plaintiffs Confident Law Is on Their Side as Abortion-Pill Ruling Looms

Supporters and opponents of chemical-abortion pills are bracing for a ruling in the coming days or weeks that could radically alter how abortions are performed in the United States, stemming from a lawsuit that claims that the Food and Drug Administration never had the authority to approve the use of the pills when it did so nearly a quarter century ago.

The FDA also failed to properly study the safety of the two-pill regimen of mifepristone and misoprostol, and for almost two decades it stonewalled the doctors who were attempting to challenge the approval of the regimen, according to the lawsuit filed by Alliance Defending Freedom, which is representing four doctors and four pro-life medical associations.

If U.S. District Judge Matthew Kacsmaryk rules in the plaintiffs’ favor, it could mean that the FDA would be forced to withdraw its approval for the two-drug abortion-pill regimen, or safeguards could be reimposed on the use of the pills for abortions. More than half of all abortions in the U.S. are now done using chemical-abortion pills rather than surgery.

The prospect of Kacsmaryk, a Donald Trump appointee, singlehandedly wiping out the FDA’s approval of the regimen has abortion-rights supporters in a panic. They’ve accused ADF of forum-shopping and have attacked Kacsmaryk as a “villain” and a “lifelong right-wing activist.” The Biden administration has vowed a legal challenge if Kacsmaryk’s ruling restricts the use of abortion pills. Vice President Kamala Harris on Friday called the suit an “an attack on women’s fundamental freedoms” and an “attack on the very foundation of our public-health system.”

But Julie Blake, a senior ADF lawyer, told National Review that they are confident the law is on their side. “It is far past time for the FDA to put politics aside, follow the science, and to begin to fulfill its responsibility to protect women and girls from chemical-abortion drugs,” she said.

Developed in France in the 1980s, the chemical-abortion process involves two pills: mifepristone, a progesterone blocker that kills the unborn child by depriving it of nutrients, and misoprostol, which causes uterine contractions to empty the uterus. While ADF is challenging the FDA’s approval of the two-pill abortion-pill regimen, the focus is on the mifepristone approval.

The 113-page ADF lawsuit, which was filed in November in U.S. District Court in Amarillo, Texas, claims that the FDA exceeded its regulatory authority in September 2000, when it approved the two-pill regimen, which then-president Bill Clinton had aggressively lobbied for.

The FDA approved the use of the regimen under a section of federal code known as Subpart H, which allows for expedited approval of potentially dangerous drugs that can be used to treat “serious or life-threatening illnesses” or that provide a “meaningful therapeutic advantage over existing treatment.” Subpart H also allows the FDA to place restrictions on the distribution of a drug — including things such as in-person dispensing requirements — to ensure its safe use.

ADF argues that the FDA had no business approving the two-drug regime under Subpart H because pregnancy is not an illness but is rather a “normal physiological state that many females experience one or more times during their childbearing years,” the lawsuit states. And Blake contends that “chemical abortion does not provide a meaningful therapeutic benefit over surgical abortion” but is, instead, “much more dangerous.”

Rather than increase scrutiny of the pills, the FDA has instead eliminated the safeguards that did exist and has made them easier to obtain, according to ADF. In 2016, the FDA increased the gestational age of the unborn baby when abortion drugs are allowed from seven weeks to ten, reduced the number of required office visits from three to one, allowed non-doctors to prescribe and administer the pills, and eliminated the requirement for prescribers to report nonfatal adverse events from chemical-abortion pills. And in 2021, during the coronavirus pandemic and after Joe Biden was elected president, the FDA announced that it would allow abortion pills to be dispensed through the mail.

Proponents of legalized abortion pills disagree that the pills are dangerous.

In a court filing, lawyers for the government wrote that mifepristone has been used in the U.S. for over two decades now, and serious adverse events associated with its use through 70 days of gestational age are rare. A group of a dozen medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, also weighed in, writing in a brief that chemical abortions, including mifepristone, are “safe and effective.” “This is not an opinion – it is a fact based on hundreds of medical studies and vast amounts of data amassed over the course of two decades,” their brief said.

But in its lawsuit, ADF claims that the FDA never studied the safety of abortion pills under the labeled conditions of use, and it failed to study how the hormone-blocking regimen might affect the developing bodies of adolescent girls. “They were either studying something different, or they didn’t have the same safeguards in place,” Blake said of the studies.

“One of the most extraordinary safeguards that the FDA eliminated was the duty of doctors to report complications after the fact when they happened under FDA’s approval of these drugs,” she said, adding that because of that lack of data, the actual impact of the drugs in the U.S. has never been appropriately studied. “The only time the FDA requires an adverse event to be reported is if a woman actually dies. And, of course, our doctors are working every day to prevent women from dying and to save their lives from these drugs.”

Blake pointed to evidence from countries such as Finland, which has more robust data on abortion-pill complications. The ADF lawsuit also notes research that found that about 10 percent of women who take abortion pills will need follow-up treatment for an incomplete or failed abortion, and more than a third of women will require surgery if they take abortion pills in their second trimester. Some women experience severe bleeding and life-threatening infections and can be left unable to have future, successful pregnancies, Blake said.

“When you allow a mail-order abortion economy, you leave women alone, you leave women without screenings for important conditions,” Blake said. “And when you allow dangerous drugs that were never tested for their labeled conditions of use, you invite complications.”

Some of the organizations ADF is representing have been attempting to challenge the FDA’s approval of the abortion drug regimen since 2002, when they filed a citizen’s petition with the agency.

“The FDA, knowing that as soon as they rejected the petition, our doctors would have the right to go to court, did two incredibly extraordinary things,” Blake said. “One, they sat on the petition for 14 years, preventing our doctors from going to court. And then, two, on the same day that they denied the citizen’s petition, they modified the drug approval, removing a number of really important safeguards on the drugs’ use, which, as you can imagine, meant that our doctors needed to then come back and file a new citizen’s petition.”

That second petition was also eventually denied.

“When people say, ‘Why didn’t you stand up for your patients before now,’ the answer is, we have, the entire time,” Blake said. “It has been the FDA that has been stonewalling out of political reasons to try and avoid any judicial review of this action.”

In addition to arguing that abortion pills are safe, lawyers for the government have argued that the plaintiffs in the case lack standing and that their theories of injury are “highly speculative.” Abortion-rights supporters have also accused of ADF of intentionally filing the lawsuit in Amarillo, knowing they would almost certainly draw Kacsmaryk, the only judge in the federal district. The Washington Post recently described Kacsmaryk as a “religious conservative who is widely regarded as a thorough and analytical legal thinker, but who also comes to his work with a long history of activism rooted in his religious beliefs.” Before he became a federal judge, Kacsmaryk was a federal prosecutor and then a lawyer for the conservative First Liberty Institute. Opponents say he has long expressed strong anti-abortion convictions.

Testifying before the Senate in 2017, Kacsmaryk vowed to be fair. “As a judge, I’m no longer in the advocate role,” he said. “I’m in the role of reading and applying with all good faith whatever Supreme Court and Fifth Circuit precedent is binding.”

When asked about the accusation that ADF sought to have Kacsmaryk hear the case, Blake noted that one of the doctors they represent is a board-certified obstetrician and gynecologist in Dumas, Texas, which is in the judge’s district. She said that within the last year that doctor helped save the life of a woman who suffered two weeks of heavy bleeding after taking abortion pills she’d obtained in New Mexico.

“There’s no requirement that you go to D.C. to complain that the federal government has broken the law and hurt you,” Blake said.

If Kacsmaryk does rule for the plaintiffs, the Biden administration would have to appeal to the conservative-leaning U.S. Court of Appeals for the Fifth Circuit.

The ADF lawsuit does not target the approval of misoprostol, which has been approved for labeled use for other benign health treatments, Blake said. Some abortion providers have suggested that if the FDA is forced to withdraw its approval of mifepristone, they could use misoprostol alone to terminate pregnancies. They argue that while it would likely be less effective, it is still safe. Blake disagrees.

“Our lawsuit does not prevent providers from using misoprostol off-label for the purpose of chemical abortion. It’s simply beyond the scope of our lawsuit,” Blake said. “However, it would be incredibly dangerous and irresponsible to induce chemical abortions through something the FDA has never approved.”