Mother Jones; Olga Fedorova/SOPA/ZUMA; Michael Nigro/Pacific Press/ZUMA; Justin Rex/AP; Tim Mossholder/Unsplash
When far-right activists won their decades-long crusade to overturn Roe v. Wade, they likely expected that eradicating the constitutional right to an abortion would result in the number of abortions plummeting. But two years after the decision in Dobbs v. Jackson Women’s Health, abortions have actually risen in the US, thanks to medications that now account for almost two-thirds of pregnancy terminations nationwide.
Conceding there were reproductive rights battles yet to be fought, a coalition of anti-abortion medical groups and doctors—represented by the Alliance Defending Freedom, the most powerful religious law firm in the country— launched an audacious attack on the Food and Drug Administration, challenging its regulation of mifepristone, a key component of medication abortions.
Today, in a unanimous decision, the Supreme Court swatted away that challenge in the case FDA v. Alliance for Hippocratic Medicine. The ruling, written by Trump appointee Justice Brett Kavanaugh, held that anti-abortion doctors and groups lacked standing to bring the lawsuit because they could not show that the FDA regulations caused them or their members any direct harm. Read the opinion here.
“Given the broad and comprehensive conscience protections guaranteed by federal law,” Justice Kavanaugh wrote, “the plaintiffs have not shown—and cannot show—that FDA’s actions will cause them to suffer any conscience injury.”
“Precedents require a plaintiff to demonstrate that the defendant’s challenged actions caused his asserted injuries.”
The ruling was hailed by abortion rights groups, which had seen the case as an existential threat. But the decision doesn’t overturn state laws that have made the abortion pill illegal or imposed restrictions on access. Nor is it likely to slow down other efforts underway to ban the abortion pill around the country, including arguments based on the Victorian-era federal obscenity law known as the Comstock Act.
And it offers little insight into how the court will ultimately decide the other blockbuster abortion-related case waiting in the wings this term: Moyle v. United States. The key issue there is whether the federal Emergency Medical Treatment and Labor Act preempts strict abortion bans in Idaho and other states.
The mifepristone decision “keeps medication abortion care safe for now,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project, but she added that dismissing the case based on standing is “a slap on the wrist—anti-abortion extremists will continue trying to put mifepristone back under lock and key.”
“This is a case that never should have reached the nation’s highest court,” Jocelyn C. Frye, President of the National Partnership for Women & Families, said in a statement. “Although this ruling staved off a catastrophic outcome, the threat has been averted temporarily, not erased.”
The case brought together an unusual coalition of business and advocacy organizations alarmed by the potential ramifications of undermining and potentially gutting, the FDA’s long-established regulatory process. Drug companies warned that rescinding the FDA’s rules on mifepristone might set off a chain reaction that would destabilize the global pharmaceutical industry. Public health advocates warned that if the attacks on the abortion pill succeeded, conservative groups would likely respond by targeting a wide array of other medications and devices, including IUDs, emergency contraception, vaccines, HIV prevention pills, and hormones used in gender-affirming care.
Mifepristone is the first of two drugs that make up the standard medication- abortion protocol in the US. Sometimes known as RU-486, it blocks the production of progesterone, the main hormone that supports the developing pregnancy. The second drug, misoprostol, causes the uterus to contract, expelling the pregnancy.
Developed by researchers in France in the 1980s, mifepristone was approved for use in that country in 1988 but banned in the US until almost the end of the Clinton administration in 2000. When the FDA finally gave its OK, it imposed several stringent conditions including: The medication could only be used through the seventh week of pregnancy, and patients had to see a doctor at least three times.
In 2016, the FDA relaxed some of those rules, allowing mifepristone to be used up to 10 weeks’ gestation while cutting the recommended dosage by two-thirds. The agency also permitted certified nurse practitioners and physician assistants to prescribe abortion pills and reduced the number of required medical appointments to a single visit. In 2021, when the pandemic wreaked havoc on all types of medical and reproductive care, the FDA removed the in-person office-visit requirement, opening the floodgates for telehealth consultations and mailed pills. The new rules were supported by more than 100 scientific studies, going back decades. As leading medical groups pointed out in an amicus brief, “Mifepristone’s safety profile is on par with common painkillers like ibuprofen and acetaminophen, which more than 30 million Americans take in any given day.”
The FDA rule changes have revolutionized abortion care in the US, even as Dobbs has emboldened conservative lawmakers to push for more draconian restrictions. Since the end of Roe, 14 states have banned abortion in virtually all circumstances, and seven more have limited the procedure to earlier in pregnancy. Yet abortions have continued to rise nationwide, according to the latest data from the Society for Family Planning’s #WeCount project: to an average of 86,000 per month in 2023, vs. 82,000/month in 2022.
Telemedicine now accounts for almost 1 in 5 of those abortions, up from just 4 percent in 2022, aided by shield laws that protect blue-state providers who ship mifepristone and misoprostol to anti-abortion states. From July to December of last year, about 40,000 patients—most of them in states with abortion bans—were able to access reproductive health care thanks to shield laws, #WeCount reports.
Enter the Alliance for Hippocratic Medicine, a coalition of five anti-abortion medical groups incorporated in August 2022 in Amarillo, Texas—not coincidentally, home to one of the most conservative federal courts in the country. Representing the coalition was the Alliance Defending Freedom, a religious-right legal behemoth that has played a pivotal role in most of the big anti-abortion and anti-LGBTQ+ court and policy battles of recent years.
ADF sued the FDA in November 2022, claiming the agency did not properly study the safety of mifepristone first when it approved its use in 2000, then when it permitted a generic version of the drug in 2019, and again when it loosened access in 2016 and 2021. Thanks to where the Alliance incorporated, the case was based in Amarillo, whose sole federal judge, Matthew J. Kacsmaryk, is a Trump appointee known for his reflexively far-right, religion-infused rulings. Kacsmaryk gave the ADF what it had been hoping for, issuing an unprecedented nationwide order in April 2023 that suspended the FDA’s approval of mifepristone. His opinion was filled with extremist rhetoric, calling providers “abortionists,” for instance, and claiming that mifepristone “starves the unborn human until death.”
The Fifth Circuit scaled back that ruling, holding that the Alliance had waited too long to challenge the FDA’s original approval and that the agency’s approval of generic mifepristone could stand. But nonetheless, it let the rest of the case proceed. The Supreme Court, meanwhile, put the Kacsmaryk and Fifth Circuit rulings on hold pending its own decision in the case.
The SCOTUS arguments this past March focused on the 2016 and 2021 rule changes. The Alliance accused the FDA of “betraying women and girls” and putting patients at grave risk. Those arguments blew up this February when three of the studies the ADF cited about mifepristone’s supposed lack of safety were retracted by their publisher, Sage. As my colleague Madison Pauly reported, an independent review of the papers found “fundamental problems,” “incorrect factual assumptions,” “material errors,” “misleading presentations,” and undisclosed conflicts of interest between the studies’ authors and anti-abortion advocacy groups.
Abortion rights organizations, meanwhile, were able to point to reams of research from around the globe showing that mifepristone is safe and effective— and that, if anything, the FDA’s regulations continue to be more conservative than real-world experience warrants. In Sweden and Norway, for example, mifepristone is routinely used through 12 weeks of pregnancy. In 2019, the World Health Organization classified mifepristone and misoprostol as “core” essential medications that it says should be available in healthcare systems at all times.
“Access to medication abortion care should never have been in question,” says Dr. Ushma Upadhyay, a researcher with Advancing New Standards in Reproductive Health. “Policies predicated on junk science have no place in health care. Decades of evidence affirm that medication abortion is safe and effective—maintaining and advancing access to it will benefit public health and patient well-being.”
For its case to succeed, the Alliance had to show that its own members would be harmed by mifepristone remaining on the market, giving them the right—or standing—to sue. Yet the coalition’s argument depended on so many hypotheticals that it seemed more like a law-school thought experiment than something that might happen to large numbers of people in the real world. The Alliance contended that a patient might be one of the rare people for whom the abortion pill didn’t work as intended, that she might then seek emergency care at a hospital, where she might encounter a provider who might belong to one of the anti-abortion groups in the lawsuit, who might be put in the position of having to perform an emergency procedure to remove the fetus.
During oral arguments, even Justices Amy Coney Barrett and Neil Gorsuch, both ardent abortion opponents, seemed skeptical that the anti-abortion groups and doctors had standing to sue. Several justices also pointed out that medical providers who object to participating in an abortion can already refuse to do so under conscience exceptions embedded in numerous federal laws since the 1970s.
In his opinion, Kavanaugh pointed to those existing conscience protections as a key reason that the anti-abortion doctors lack standing in this case. “As the Government explains, federal conscience laws definitively protect doctors from being required to perform abortions or to provide other treatment that violates their consciences,” he wrote, adding that those protections mean that “doctors cannot be required to treat mifepristone complications in any way that would violate [their] consciences.” The same conscience protections apply to the federal Emergency Medical Treatment and Labor Act, Kavanaugh wrote, alluding to oral arguments in the other big abortion case of the term. “EMTALA does not require doctors to perform abortions or provide abortion-related medical treatment over their conscience objections because EMTALA does not impose obligations on individual doctors,” he wrote.
“Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue,” Kavanaugh wrote.
Nor did the Kavanaugh and his colleagues buy the Alliance’s somewhat circular argument that because anti-abortion groups had spent so much time and money fighting the FDA over mifepristone, the costs of that fight gave them—as opposed to their individual members—a separate standing to sue. “An organization that has not suffered a concrete injury caused by a defendant’s action cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action,” Kavanaugh wrote. “An organization cannot manufacture its own standing in that way.”
Justice Clarence Thomas, who during oral arguments had seemed to be one of the lawsuit’s possible defenders, wrote a concurrence that underscored his agreement with the other justices. But he also took aim at the concept of “third-party standing” — often evoked by doctors on both sides of the abortion fight to bring lawsuits on behalf of their patients. “Precedents require a plaintiff to demonstrate that the defendant’s challenged actions caused his asserted injuries,” Thomas wrote, adding: “Just as abortionists lack standing to assert the rights of their clients, doctors who oppose abortion cannot vicariously assert the rights of their patients.”
