The Latest Attack on the Abortion Pill Is Forty Years in the Making

1987, MS. The magazine asked me to write about RU-486, a new drug that causes the uterus to release a fertilized egg before it can go to term. It wasn’t birth control, but it wasn’t what most people considered an abortion either. At the time, anti-abortion advocates were peddling ultrasound images that purported to show fetuses screaming in pain while they were surgically removed. RU-486, developed in France but not yet available in the United States, threatened to impede this tactic: there would be no fetal development to display. Even the president of the National Right to Life Committee acknowledged that images of women who appeared to be menstruating had little PR value. This disarming of the pro-life movement and the drug’s seemingly harmless effects, I wrote, “may serve to decimate the anti-abortion ranks.” Étienne-Émile Baulieu, the main developer of RU-486, better known as mifepristone, was even more hopeful. With this drug, he explained, “abortion should more or less disappear as a concept, as a fact, as a word in the future.”

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Mifepristone, which is given with the drug misoprostol, now accounts for more than half of all abortions in the United States. The FDA approved it for use within the first seven weeks of pregnancy in 2000, and sixteen years later expanded its use to within ten weeks. In 2021, the FDA lifted the requirement that the drug be dispensed only in medical facilities; That way it could be mailed. In January, the agency allowed retail pharmacies to apply for certification to sell it in their stores by prescription. But by then, a Tennessee-based group called the Alliance for Hippocratic Medicine had sued the FDA in Texas’ Northern District, alleging, among other things, that the agency made a mistake in approving the drug twenty-three years ago. If the group prevails, there is a chance that mifepristone will no longer be available anywhere in the country, even in states where abortion is legal.

Why the Alliance for Hippocratic Medicine, a Tennessee-based organization, would file a lawsuit in Texas, a state that has already banned surgical and medical abortions, has everything to do with Presiding Judge Matthew Kacsmaryk’s anti-abortion views. Kacsmaryk joined the bench from the First Liberty Institute, a conservative Christian rights organization, where he advocated arguing that pharmacists should be able to refuse women emergency contraception and calling those fighting for reproductive rights “sexual revolutionaries.” The Fifth Circuit Court of Appeals, which hears cases originating in Kacsmaryk’s courtroom, has long been considered the most conservative judicial body in the country. Trump appointed six of his judges, one deploring “the moral tragedy of abortion” and another writing that same-sex marriage “endangers civil peace,” a view Kacsmaryk has echoed in his own writings. By finding a sympathetic judge, the Alliance for Hippocratic Medicine was able to present a weak case full of flawed arguments that has the potential to disadvantage anyone who can get pregnant, neutralize the FDA, limit drug development, and undermine the authority of federal agencies. To be clear, plaintiffs are not directly seeking a ban on mifepristone. Rather, they are asking the court to issue an injunction to take the drug off the market nationwide.

The Alliance for Hippocratic Medicine, represented by the same legal team that argued the Mississippi case leading to the overturning of Roe v. Wade has produced a smorgasbord of allegations to support her case. For example, they argue that “the FDA has never evaluated the safety of the drugs under the stated conditions of use.” But in an amicus brief for the FDA, the American College of Obstetricians and Gynecologists, the American Medical Association, and other clinical experts note that the FDA’s first review actually included clinical test results, and that was in 2016, when the agency stopped using mifepristone to 10 weeks, the decision was “supported by substantial evidence, including a wide-ranging systemic review, a randomized controlled trial and several observational studies” involving more than thirty thousand participants. And then, of course, there is the empirical evidence that has been accumulated over the past 23 years. Mifepristone has been used nearly four million times. Its safety profile is comparable to ibuprofen, penicillin and Viagra.

The alliance also claims that the FDA exceeded its powers when approving the drug because pregnancy is not a disease. But a group of nineteen FDA legal scholars, in a separate amicus brief, point out that the FDA’s jurisdiction also extends to “conditions” such as pregnancy, and to suggest that it doesn’t is inaccurate and ahistorical.

The Alliance’s most ludicrous claim might be that medical abortions (which they call chemical abortions, presumably because it sounds scarier) would result in the draining of emergency room resources for women who need medical care for complications caused by the two drugs Regime. Complications from medical abortions are not only extremely rare – less than half a percent require hospitalization – it’s far more likely that making medical abortions more difficult will put a strain on the health care system itself, as desperate women and teenagers will resort to — abortions like the ones they are in did the days before Roe. In addition, mifepristone is also used to treat miscarriage and other pregnancy-related conditions; Removal from a doctor’s arsenal will also increase the burden on patients, doctors, and the medical system in general.

During the 2017 Kacsmaryk confirmation hearing, he said that he “would not advocate for any particular policy” because of his religious beliefs. There’s a chance he might end up being a man of his word and will view this case as the ideological hyperbole it is. But if Judge Kacsmaryk accepts the plaintiff’s arguments and issues a statewide injunction, the Justice Department will likely seek a stay, which, if granted, will keep mifepristone in circulation until the case reaches the Supreme Court. But first an appeal would have to be made to the Fifth Circuit, which is overseen by Samuel Alito, the author of the decision to overturn Roe, who can decide whether the case goes to full court. One might assume that the six Supreme Court justices who overthrew Roe would be sympathetic to efforts to abolish medical abortion, particularly in states where abortion remains legal. The court could follow its playbook in West Virginia against Environmental Protection Agency, using what it calls the Major Question Doctrine, a concoction created to strip the agency of its power to regulate carbon emissions, stating that if a federal agency decides an issue of great national importance, the decision must be approved by clear instructions from Congress. But it’s anyone’s guess. For example, at least two of the court’s conservative judges, Thomas and Gorsuch, have criticized statewide injunctions made by a single judge in a single district.

And then there’s the FDA itself. In their amicus brief, the FDA’s nineteen legal scholars warn that by siding with the alliance, Kacsmaryk will undermine the authority of a federal agency tasked with determining whether a drug is safe or not. This, they write, “could go well beyond mifepristone.” Drug manufacturers would not only have to determine whether a drug is needed and safe, but also whether there is the political and legal will to bring it to market. As FDA legal scholars wrote in their letter, “This would fundamentally disrupt industry expectations, leave manufacturers vulnerable to challenges with their currently marketed drugs, and discourage investment in research and development of new drugs.” David S. Cohen, law professor at the Drexel University, recently wrote in Slate that even if Kacsmaryk decides that the FDA’s original approval of mifepristone was unlawful, “he cannot compel the FDA to enforce the decision.” However, it remains unclear whether Biden’s FDA would seek a judicial review Ignore the decision and open up to criticism for taking a political stance.

Heralding the future, Walgreens, the country’s second-largest pharmacy chain, has already announced that it will not stock the drug in states where abortion is banned or severely restricted. But under threat of lawsuits, they also refuse to sell in four states where abortion remains legal. Regardless of how the case is resolved in court, such moves are likely to have far-reaching consequences. Reducing the market for a drug gives its manufacturer less incentive to keep making it. “It would have been one thing to announce in advance that Walgreens would agree to comply with the ruling if it came out that the drug would be withdrawn, but quite another to pre-empt it and essentially say even if it was.” these drugs are safe, effective, and recognized as such by the FDA, and the courts recognize that they should remain on the market, we choose right now not to make them available,” said I. Glenn Cohen, Harvard law professor and one of those nineteen FDA grantees told me. “It takes a lot to shock me in this area, but I found it shocking.”

Almost forty years ago, for my piece in MS., I spoke to Jacqueline Darroch Forrest, then director of research at the Guttmacher Institute, the nation’s leading reproductive rights research and advocacy organization. People are “over-excited” by the prospect and promise of RU-486, she told me, because it’s unlikely to be available in the United States any time soon — if at all. Like Baulieu and I, Forrest was wrong. But maybe, after all these years, she’s finally right. ♦