Almost two years after ending a constitutional right to abortion, the Supreme Court returns to that intense controversy on Tuesday, exploring this question: will women still have full access to the most common method for safely ending a pregnancy – the “abortion pill”? The Court will also examine the power of the courts to decide that question.
For a century and a half – that is, since the 1870s – America has been debating abortion as a national issue. In 1873, Congress passed the “Comstock Act,” banning the mailing of any device or medicine used to cause abortion. That was the high point of a wave of new laws criminalizing the procedure.
The Act was never fully repealed, but it was made mostly meaningless a century later, when the Supreme Court issued its 1973 decision in Roe v. Wade protecting abortion as a woman’s constitutional right. However, Roe v. Wade was overruled by the Court in the famous Dobbs v. Jackson Women’s Health Organization decision in June 2022, reopening the nationwide controversy and threatening reproductive rights anew.
The threat deepened quickly. Five months after the Dobbs decision, abortion opponents went to federal court in Amarillo, Texas, in an attempt to force the abortion pill completely off the market. That court has only one judge, one with a strong conservative record: U.S. District Judge Matthew J. Kaczmaryk.
Last April 7, the judge relied upon the long-dormant Comstock Act as authority for blocking the nationwide distribution of the drug, mifepristone. That medicine is used in a two-drug combination allowing, under federal drug policy, a pregnant woman to end a pregnancy in the privacy of her home.
Judge Kaczmaryk declared that, when the challenge goes to a trial, it would very likely succeed on the claims that the U.S. Food and Drug Administration had no authority to approve that method when it first did so in 2000, and no authority to make it more widely available in later actions. That decision to forbid distribution was put on hold temporarily by the Supreme Court last year, so the procedure remains fully available as of now. These cases put the issue back before the Supreme Court in the first abortion dispute to be heard by the Justices since Roe v. Wade was cast aside.
Tuesday hearing, combining two cases: Food and Drug Administration v. Alliance for Hippocratic Medicine (and others) and Danco Laboratories v. Alliance for Hippocratic Medicine (and others). The hearing begins at 10 a.m. and is scheduled for one hour.
Background: What is the “abortion pill,” and how does it work? Some 63 percent of all abortions in the nation are now done by this method; nearly 6 million women in America have used the procedure to end pregnancy. Used fairly early in pregnancy (up to ten weeks), it is considered by the FDA and numerous studies to be very safe, and has fewer complications than abortion by surgery. Depending upon the outcome of these Supreme Court cases, it may remain available – as it now is — by mail and from drugstores, so that it can be used at home. It can be bought in both brand-name and generic versions.
In a medical (non-surgical) abortion, the procedure most often involves two drugs, not one. Both are available only by a prescription by a doctor or a nurse practitioner. The first pill is mifepristone, which blocks a natural hormone that is needed to sustain a pregnancy. The second is misoprostol, a drug originally approved by the FDA for treating stomach ulcers. In combining the two, the procedure causes contractions that empty the uterus.
The dispute over this procedure is now a dominant one in the aftermath of the Court’s Dobbs decision, with more state legislatures and courts narrowing women’s access to abortion. So, the Justices’ decision on these two appeals is eagerly awaited. One appeal is by the FDA, the other is by the drug-making firm Danco Laboratories; Danco’s only product is mifepristone, sold under the brand name Mifeprex. (The company’s location and its officers are kept secret, fearing retaliation for its marketing of mifepristone.)
At this point, the two-drug procedure’s wide availability is the result of both the Justices’ temporary order last April blocking Judge Kaczmaryk’s order and the Justices’ vote last December to hear these appeals while at the same time denying review of a separate appeal by the abortion foes, attempting to revive their plea to ban the procedure altogether.
It may be, however, that the coming ruling by the Court will not settle the terms of the procedure’s availability because there is a basic question of the challengers’ right to file their lawsuit at all. That question must be answered by the Court first.
Since 1793, the Court has interpreted the Constitution’s Article III grant of power to the federal courts to require that there be a genuine legal dispute for a court to act. Federal courts may not decide abstract legal issues or give legal advice on hypothetical questions. This limitation is called the “standing” doctrine, meaning simply: did those who sue have a right to do so? This is, fundamentally, a question of a court’s power. Because that is now up to the Court to decide, Judge Kaczmaryk in Amarillo is still waiting to begin a formal trial.
Who are the challengers? The Texas lawsuit was filed by four medical associations, whose members are opposed to abortion as a matter of their religious or moral views, and four doctors who share those views. Both Judge Kaczmaryk and the federal appeals court ruled that those who sued have a keen interest in the issue and, most importantly, that each would be harmed in a legal sense by FDA’s actions.
The four doctors, while not prescribing the procedure in their own practices and not being required by FDA to do anything themselves, may encounter women who have had the procedure and may come to them in emergency situations of side-effects or complications, according to the lower courts’ conclusions. Doctors may find themselves having to perform procedures that their consciences forbid them to do, and may be diverted from their normal practices to provide such care, the courts found.
The appeals court, differing in part with Judge Kaczmaryk, ruled that none of those who sued could show any harm from FDA’s approval of a generic version of mifepristone, so none had a right to challenge that version. The appeals court also ruled that the challengers had waited too long to oppose FDA’s original approval of mifepristone in 2000, so that claim was barred.
The appeals court, like Judge Kaczmaryk, ruled that the FDA had acted illegally when it took actions in 2016 and 2021 to make mifepristone more easily available and more convenient for pregnant women to use. Both of the lower courts also found fault with FDA for failing, in those courts’ perception, to fully assess the risk of the abortion bill method, questioning the reliability of some of the scientific studies on which the agency had relied for its actions on mifepristone.
What has the FDA done about the pill? Mifepristone, invented in France in 1980 and known there as RU-486, was first approved in 2000 by FDA as a safe and effective new drug for use in the U.S. That was based on four years of study. The initial approval of the procedure was for the brand-named Mifeprex version. (In 2019, FDA approved the use of a generic version – an action no longer in dispute.) The 2000 ruling by FDA covered not only the use of mifepristone, but also its use together with misoprostol for medical abortion.
As usual when allowing a new drug to go on the market, FDA in 2000 spelled out how mifepristone had to be used in order to work and to be safe. It specified that only a doctor could prescribe it, and had to do so in a personal visit with the woman.
Other requirements were that the woman had to visit the doctor three times: to take mifepristone, then two days later to take misoprostol, and then two weeks later a follow-up visit to confirm that the pregnancy had been terminated. The FDA also limited the use of mifepristone to only the first seven weeks of pregnancy.
If the Supreme Court were now to uphold the procedure as the federal appeals court would have allowed, those original conditions would return for any woman seeking the procedure. Over the years after 2000, however, FDA took repeated action to ease access.
These changes are the ones now at issue before the Court (that is, if the Court does decide the legality issue in the way urged by FDA and Danco Laboratories, and not just the right-to-sue issue):
- In 2016, FDA allowed the procedure with only one in-person visit to the doctor, extended the period of use from seven to ten weeks, and allowed licensed health-care providers other than doctors to issue prescriptions. The agency justified those changes after finding that studies showed that serious side-effects would be “exceedingly rare.”
- In 2021, based on further studies, the agency removed the in-person visit requirement for dispensing the drug. That opened the way for women to obtain it by mail or buying it in retail pharmacies. There still must be a prescription by a doctor or a nurse practitioner.
After the appeals court’s latest ruling, FDA and Danco Laboratories appealed to the Supreme Court.
The questions before the Court: Did any of the challengers have a right to file this lawsuit, and thus did the courts have authority to decide it? Did the FDA act legally in 2016 and 2021 in easing access to mifepristone? Will the 1873 anti-abortion Comstock Act play any role in judging what FDA has done? Did Judge Kaczmaryk have authority to issue his sweeping order after only a preliminary review?
Significance: The impact of the Supreme Court’s coming decision in these cases depends, in a significant way, on whether a ruling goes beyond the question of the challengers’ right to sue to test the FDA’s actions. It is extraordinarily rare for courts to question the FDA’s expertise in deciding whether a drug is safe and effective. If this dispute is allowed to go forward, it could have a major influence on drug regulation in general, as well as posing a potential threat to abortion access for tens of thousands of women each year. (The most recent data show that, within the last full year, 642,700 abortions were performed with the use of the two medicines, not surgery.)
The Court’s current conservative majority has lately been more willing to expand the right to sue, so these cases could be a new test of that trend.
If the Court rules that the challengers’ case was barred, that would end it and leave in place the full access that the FDA decisions have sought to assure. However, should the Court instead rule that this lawsuit was permitted, the Justices could move on to decide the legality of what the FDA did in 2016 and 2021. Both sides have argued that question at length in their legal briefs, so it is set up for the Court as ready for a ruling. The FDA has gone to considerable lengths, in its filings, to persuade the Court that its core function of making sure that drugs are safe is at issue in this controversy, and that the entire pharmaceutical industry’s reliance on FDA analyses is seriously at risk.
There is a further, large significance here, if the Court does go ahead to judge FDA’s powers: This will be the first time since the Court cast aside the constitutional basis for abortion that the Justices have faced any of the consequences that have developed following that decision. By turning the control of access to abortion largely over to state governments, the Dobbs decision of 2022 has set loose a wide campaign by opponents of abortion – in and out of public office – to curtail access to any form of procedure for ending pregnancy.
This dispute does not involve action at the state level, but it does confront the Justices with the real-world impact on women of their loss of reproductive choice and what it means when pregnancy may have to continue under the compulsion of law and public policy, especially in the face of an unrelenting effort to completely eliminate the procedure.
The Court’s majority, of course, will not reconsider the Dobbs decision, but it surely has a good deal of information – in the large stack of briefs filed in these cases – that it did not have before about abortion access when there is no longer dependable constitutional protection for that choice. The FDA policy at the center of this dispute has been its own promise that women will have that choice, so the agency’s power is of profound consequence.
If the Court were to find any serious flaws in the FDA process for mifepristone, that could also threaten the legality of its approval of birth-control pills and of fetility drugs used in the IVF procedure to help achieve pregnancy. The anti-abortion movement appears determined to accomplish, as a nationwide priority, the legal and constitutional principle that no fertilized human egg can ever be destroyed or prevented from development, because life, in that view, begins at conception. In the opening weeks of this year, more than 40 bills to recognize “personhood” for embryos or fetuses have been introduced in 16 states’ legislatures.
It will be of passing interest if the Court were now to say anything about the Comstock Act of 1873, and whether it must decide anything about its current effect – if any. Judge Kaczmaryk definitely relied upon it in ruling against FDA, and one of the three judges on the appeals court panel would have based that court’s narrower decision on the old law. The challengers have briefly raised it in their legal filings, and the FDA has replied that it is not a factor here because that law says nothing about FDA’s power.
The Court will broadcast “live” the audio (no video) of this hearing on its homepage, supremecourt.gov To listen, click on “Live Audio” and follow the prompt when the courtroom scene appears lower on the page. The audio also will be available, under the title of the two cases, on C-Span TV at this link: cspan.org/supremecourt
