The Supreme Court heard oral arguments Tuesday in a case challenging the Food and Drug Administration’s relaxation of rules that govern how abortion-causing drugs are given and accessed.
The abortion drug mifepristone has been legally available in the United States since FDA approval in 2000. The FDA, in 2016 and 2021 under Presidents Obama and Biden, removed what pro-life advocates and some doctors argue were medically valid safeguards in order to increase access to the abortion drug regimen of mifepristone and its companion drug, misoprostol.
With those safeguards removed, women can access the abortion drugs by mail delivery and without in-person medical visits. Further, the abortion pills are legally available at 10 weeks’ gestation, up from six weeks when the FDA first approved mifepristone in 2000.
Pro-life groups, along with the respondents in the case, four doctors and four medical associations led by the Alliance for Hippocratic Medicine, have argued the relaxed FDA standards put more women at risk of serious complications.
Erin Hawley, a senior counsel at Alliance Defending Freedom, which represented the groups of Christian physicians and health care workers including emergency room doctors who deliver babies, told the court that the FDA in 2021 “approved abortion by mail based on data it admitted was not adequate” and violated legal requirements in doing so.
“FDA’s outsourcing of abortion drug harm to [the] respondent doctors forces them to choose [in emergency room situations] between helping a woman with a life-threatening condition and violating their conscience. This hostage choice is intolerable,” argued Hawley, a law professor and the wife of Sen. Josh Hawley (R-Missouri).
“On the merits, FDA failed to comply with basic APA [Administrative Procedure Act] requirements. In 2021, it eliminated the initial in-person visit based on data it says elsewhere is unreliable,” Hawley added. “And in 2016, it failed to consider or explain the cumulative effect of its wholesale removal of safeguards. These actions fall far short of what the APA requires and this court should affirm.”
Meanwhile, the government’s solicitor general and attorneys for the abortion drug manufacturer Danco questioned whether the respondents in the case had proper legal grounds to challenge the FDA’s policies because they offered no specific instances where they were forced to participate in abortions.
Several commentators observed that the question of legal standing seemed to resonate among several justices from both the conservative and liberal sides of court, though no justice said as much outright.
During oral arguments, Hawley sought to dispel such notions, stating that the FDA relies on “O.B. hospitalists to care for women harmed by abortion drugs. … The FDA concedes that between 2.9% and 4.6% of women [using the drug regimen] will end up in the emergency room. And … the FDA acknowledges that women are even more likely to need surgical intervention and other medical care without an in-person visit.”
Hawley added, “Ruling against respondents on standing here would allow federal agencies to conscript nonregulated parties into violating their consciences and suffering other harms without judicial recourse.”
When the FDA approved mifepristone in 2000, it was over objections from pro-life advocates and some physicians that the drug posed too many health risks. In 2016, the FDA under Obama expanded accessibility of mifepristone but also eliminated the requirement that health-care providers report non-fatal complications, or “adverse effects.” Because of this, pro-life groups have argued that such complications are under-reported.
At one point, Justice Samuel Alito seemed to question the wisdom of the FDA’s 2016 decision to stop requiring the reporting of non-fatal complications as he questioned the attorney for Danco.
“Why would [reporting] be a bad thing?” Alito asked. “Wouldn’t your company—you don’t want to sell a product that—that causes very serious harm to the people who take your product, relying on your tests and the FDA’s tests. Wouldn’t you want … that data?”
Another question in the case is whether delivery of abortion drugs by mail violates an 1873 law still on the books, the Comstock Act. That law forbade postal delivery of obscene materials, which included pornography but also substances that cause abortion. In 1971, Congress amended the act to allow the mailing of contraceptives.
In April 2023, U.S. District Judge Matthew Kacsmaryk ruled that the FDA approved the drug despite “legitimate safety concerns.” His ruling sought to suspend the FDA’s initial approval of mifepristone in 2002 and subsequent rulings relaxing rules on its use and availability.
In August, the U.S. 5th Circuit Court of Appeals, based in New Orleans, ruled that too much time had passed for the respondents to challenge the FDA’s approval of mifepristone, but it did uphold Kacsmaryk’s judgments on the FDA’s decisions in 2016 and 2021, ruling that the FDA must restore the safeguards around chemical abortion drugs and prohibit their shipment by mail to protect the health and safety of women.
The high court is expected to announced a ruling by late June or early July.
Photo: Dalibor Brlek / Alamy Stock Photo