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

In 1987, Ms. magazine asked me to write about RU-486, a new medication that caused the uterus to expel a fertilized egg before it could gestate. It wasn’t a contraceptive, but it wasn’t what most people considered an abortion, either. At the time, anti-abortion campaigners were brandishing ultrasound images that purported to show fetuses crying out in pain as they were being surgically removed. RU-486, which was developed in France but not yet available in the United States, threatened to stymie this tactic: there would be no fetal development to flaunt. Even the president of the National Right to Life Committee acknowledged that there was little P.R. value in images of what appeared to be menstruating women. This disarming of the pro-life movement, and the drug’s seemingly benign effect, I wrote, “may serve to decimate the ranks of abortion foes.” Étienne-Émile Baulieu, the primary developer of RU-486, which is better known as mifepristone, was even more hopeful. With this drug, he declared, abortion “should more or less disappear as a concept, as a fact, as a word in the future.”

Mifepristone, administered in conjunction with the drug misoprostol, now accounts for more than half of all abortions in the United States. The F.D.A. approved it for use within the first seven weeks of pregnancy, in 2000, and, sixteen years later, extended its use to within ten weeks. In 2021, the F.D.A. removed the requirement that the drug only be dispensed in medical settings; that way, it could be sent through the mail. In January, the agency allowed retail pharmacies to apply for a certification to sell it by prescription in their stores. But, by then, a Tennessee-based group called the Alliance for Hippocratic Medicine had sued the F.D.A. in the Northern District of Texas, claiming, among other things, that the agency erred 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, an organization based in Tennessee, would file a lawsuit in Texas, a state that has already outlawed surgical and medical abortion, has everything to do with the anti-abortion views of the presiding judge, Matthew Kacsmaryk. Kacsmaryk came to the bench from First Liberty Institute, a conservative Christian legal organization, where, as counsel, he argued that pharmacists should be able to deny women emergency contraceptives and called those who fight for reproductive rights “sexual revolutionaries.” The Fifth Circuit Court of Appeals, which hears cases that emanate from Kacsmaryk’s courtroom, has long been considered the most conservative judicial body in the nation. Trump appointed six of its justices, one of whom decried “the moral tragedy of abortion” and another who wrote that same-sex marriage “imperils civic peace,” a view that Kacsmaryk has echoed in his own writing. By shopping for a sympathetic judge, the Alliance for Hippocratic Medicine has been able to present a weak case, full of spurious arguments, that has the potential to disadvantage anyone who can become pregnant, neuter the F.D.A., curtail drug development, and undermine the authority of federal agencies. To be clear, the plaintiffs are not asking for a ban on mifepristone outright. Rather, they are petitioning the court to impose an injunction to take the medicine off the market nationally.

The Alliance for Hippocratic Medicine, which is being represented by the same legal team that argued the Mississippi case that led to the repeal of Roe v. Wade, has presented a hodgepodge of claims to support its case. They argue, for instance, that “the F.D.A. never studied the safety of the drugs under the labeled conditions of use.” But, in an amicus brief for the F.D.A., the American College of Obstetricians and Gynecologists, the American Medical Association, and other clinical experts note that the F.D.A.’s initial assessment did, in fact, include clinical test results, and that, in 2016, when the agency extended mifepristone’s use to ten weeks, the decision “was supported by substantial evidence, including a wide-ranging systemic review, a randomized control trial, and several observational studies” that included more than thirty-thousand participants. And then, of course, there is the empirical evidence collected in the past twenty-three years. Mifepristone has been used nearly four million times. Its safety profile is comparable to ibuprofen, penicillin, and Viagra.

The Alliance is also claiming that, because pregnancy is not an illness, the F.D.A. exceeded its authority when it approved the drug. But a group of nineteen F.D.A. legal scholars point out, in a separate amicus brief, that the purview of the F.D.A. also extends to “conditions” such as pregnancy, and to claim that it does not is inaccurate and ahistorical.

The most ludicrous assertion by the Alliance may be that medical abortions (which they call chemical abortions, presumably because it sounds creepier) would lead to emergency-room resources being drained by women in need of medical care for the complications caused by the two-drug regimen. Not only are complications from medical abortion exceedingly rare—less than half a per cent require hospitalization—it is far more likely that making medical abortions more difficult to obtain will itself burden the health-care system, since desperate women and teens will resort to do-it-yourself abortions, as they did in the pre-Roe days. Moreover, mifepristone is also used to treat miscarriages and other pregnancy-related conditions; removing it from a physician’s armamentarium will also increase the burden on patients, doctors, and the medical system more generally.

During Kacsmaryk’s confirmation hearings, in 2017, he said that he would “not advocate for particular policies” based on his religious beliefs. There is a chance that he may end up being a man of his word and see this case as the ideological overreach that it is. But, if Judge Kacsmaryk does accept the plaintiff’s arguments and issues a nationwide injunction, the Justice Department is likely to request a stay, which, if granted, will keep mifepristone in circulation until the case makes it to the Supreme Court. But first, an appeal would have to be presented to the Fifth Circuit, which is overseen by Samuel Alito, the author of the decision that repealed Roe, who can decide whether to present the case to the full court. One might assume that the six Supreme Court Justices who overturned Roe would be sympathetic to efforts to eliminate medical abortions, especially in states where abortion remains legal. The court could follow its playbook in West Virginia v. Environmental Protection Agency and use the so-called major-questions doctrine, an invention created to strip the agency of its authority to regulate carbon emissions, which says that if a federal agency is ruling on an issue of major national significance, the decision must be authorized by clear congressional guidance. But it’s anyone’s guess. At least two of the court’s conservative Justices, Thomas and Gorsuch, for instance, have been critical of nationwide injunctions made by a single judge in a single district.

And then there is the F.D.A. itself. In their amicus brief, the nineteen F.D.A. legal scholars warn that, if Kacsmaryk sides with the Alliance, he will be undermining the authority of a federal agency assigned to determine if a drug is safe or not. This, they write, “could extend far beyond mifepristone.” Drug manufacturers would not only have to determine whether a drug is needed and safe but also if the political and judicial will exists to bring it to market. As the F.D.A. legal scholars wrote in their brief, “This would fundamentally confound the expectations of industry, leave manufacturers vulnerable to challenges to their currently marketed drugs, and discourage investment in research and development of new drugs.” David S. Cohen, a law professor at Drexel University, recently wrote, in Slate, that, even if Kacsmaryk decides that the F.D.A.’s initial approval of mifepristone was unlawful, “he cannot force the F.D.A. to enforce the decision.” But it remains unclear if Biden’s F.D.A. would ignore a judicial decision and open itself up to criticism that it is taking a political stance.

In what may be a harbinger of things to come, Walgreens, the nation’s second-largest pharmacy chain, has already announced that it would not carry the medicine in the states where abortion has been outlawed or severely restricted. But, under threat of litigation, they are also declining to sell in four states where abortion remains legal. No matter how the case is resolved in the courts, such moves will likely have far-reaching consequences. Reducing the market for a drug gives its manufacturer less incentive to continue to make it. “It would have been one thing to pre-announce that Walgreens would agree to abide by the ruling, should it come out that the drug is withdrawn from the market, but quite another to get ahead of it and essentially say, even if these drugs are safe, effective, recognized as such by F.D.A., and the courts recognize they should remain on the market, we are deciding right now not to provide them,” I. Glenn Cohen, a Harvard law professor and one of those nineteen F.D.A. scholars, told me. “It takes a lot to shock me in this area, but I did find this shocking.”

Almost forty years ago, for my piece in Ms., I spoke with Jacqueline Darroch Forrest, who was then the research director of the Guttmacher Institute, the nation’s premier reproductive-rights research and advocacy organization. People were “over-excited” about the prospect and promise of RU-486, she told me, because it was unlikely to be available in the United States anytime soon—if ever. Like Baulieu and me, Forrest was wrong. But maybe, after all these years, she will finally be proved right. 

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