The Biden administration asked the Supreme Court to overturn a lower court’s ruling that reversed regulations that had made abortion pill mifepristone easier to obtain.
A medication abortion generally involves the use of mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions. Mifepristone is also known as Mifeprex and RU-486. Misoprostol, which is widely available because it has many medical uses, isn’t an issue in the current litigation.
The court’s decision in the exhaustively litigated case could affect the availability of mifepristone.
In 2016, the Food and Drug Administration (FDA) changed the drug’s official label and extended the cutoff for its use from 49 days of gestation to 70 days. At the same time, the agency allowed the drug to be prescribed with only one in-person visit and halted the requirement that prescribers report nonfatal adverse events related to the drug.
In 2021, the FDA allowed prescriptions to be sent by mail.
Opponents of the abortion pill argue that the 2016 and 2021 regulatory changes removed important protocols intended to protect women.
The Supreme Court will hear two consolidated cases, Danco Laboratories LLC v. Alliance for Hippocratic Medicine (AHM), and FDA v. AHM, together on March 26.
The mission statement page on the AHM website states that the group “upholds and promotes the fundamental principles of Hippocratic medicine.”
“These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing health care with the highest standards of excellence based on medical science,” it states.
Among the AHM’s “partnering organizations” are groups such as the American College of Pediatricians, the American Association of Pro-Life OBGYNs, and the Christian Medical and Dental Associations. Individuals cannot apply for AHM membership.
FDA Controversy
The legal controversy began last year when U.S. District Judge Matthew Kacsmaryk of Texas, an appointee of President Donald Trump, held that the FDA was wrong to approve mifepristone for public use in 2000 and that the agency had deliberately dragged out judicial review of the drug for years.The judge also found that the FDA had improperly lifted restrictions related to accessing the drug. He issued a preliminary nationwide injunction retroactively staying the FDA’s approval.
The judge wrote that the FDA had not properly assessed the drug’s risks before approving it, buckling under political pressure to get it on the market.
The U.S. Department of Justice (DOJ) appealed against Judge Kacsmaryk’s decision, but the conservative-leaning U.S. Court of Appeals for the Fifth Circuit declined to block most of the order.
The appeals court held that the FDA’s actions in 2016 and 2021 were probably unlawful—a finding that the FDA and Danco Laboratories have asked the Supreme Court to review.
In August 2023, the Fifth Circuit upheld the district judge’s restrictions on the abortion pill, holding that the FDA failed to give proper consideration to public safety concerns when approving it.
The Fifth Circuit noted that the AHM and the other plaintiffs argued that they had “associational standing” because the various organizations involved in the lawsuit have members who “are likely to sustain injuries as a result of FDA’s actions.”
The court found that the plaintiffs “made a ‘clear showing’ that their members face injury with sufficient likelihood to support entering a preliminary injunction.”
The DOJ appealed to the Supreme Court, which blocked the injunction over the original approval of the drug, allowing mifepristone to remain on the market.
In September 2023, U.S. Solicitor General Elizabeth Prelogar told the Supreme Court in a brief that the Fifth Circuit’s ruling was the first time that a court had second-guessed the FDA’s “expert judgment” in approving medication.
The courts also erred in countermanding the FDA’s “scientific judgments by imposing novel requirements that have ‘alarmed the entire pharmaceutical industry’ ... and in ordering disruptive preliminary relief,” she wrote.
“[AHM’s] attempt to defend those holdings only underscores how far the decisions below strayed from black-letter Article III, administrative law, and equitable principles,” Ms. Prelogar wrote.
Article III of the U.S. Constitution deals with the powers of the federal judiciary.
AHM provided evidence related “to only seven identified doctors, whose declarations span just a few dozen pages and are often vague or conclusory,” and the lower courts “did not even purport to find that those barebones declarations establish that any identified doctor satisfies Article III,” she wrote.
The Biden administration also claims that mifepristone is safe for women to use.
Studies involving tens of thousands of women demonstrate that “the serious adverse events that could give rise to the emergency situations” that could involve physicians “are extremely rare.”
“Hospitalization, serious infections, and bleeding requiring a transfusion each occur in between [zero percent] and 0.7 [percent] of cases,” the new brief states.
The brief comes after Danco Laboratories, which makes mifepristone, filed its own brief on March 14, stating that the Fifth Circuit’s decision “to enjoin FDA’s 2016 and 2021 decisions was unprecedented.”
The decision should be reversed because the AHM’s “claim to standing combines a statistical theory of future injury to unnamed members ... with claimed past injury by a few members ... for parties unregulated by the challenged action ... without linking traceability or redressability to the challenged action,” Danco’s attorney, Jessica Ellsworth of Washington law firm Hogan Lovells, wrote.
