Supreme Court to hear abortion pill case after FDA loosens dispensing rules
The U.S. Supreme Court has agreed to hear a legal challenge related to the U.S. Food & Drug Administration's loosening of restrictions on how the chemical abortion pill mifepristone can be distributed and who can distribute it to patients.
In a miscellaneous orders list released Wednesday, the high court agreed without comment to hear the combined cases of FDA et al v. Alliance Hippocratic Medicine et al and Danco Laboratories LLC v. Alliance Hippocratic Medicine et al.
While the Supreme Court granted the requests by the Biden administration to review lower court rulings against its relaxing of longstanding distribution regulations, the high court rejected the request of pro-life organizations to weigh in on the legality of the FDA's 2000 approval of mifepristone.
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White House Press Secretary Karine Jean-Pierre praised the court's decision to take on the administration's appeal of the 5th Circuit ruling on mifepristone, which she claims "threatens to undermine the FDA's scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion."
"This Administration will continue to stand by FDA's independent approval and regulation of mifepristone as safe and effective," she said in a statement. "As the Department of Justice continues defending the FDA's actions before the Supreme Court, President Biden and Vice President Harris remain firmly committed to defending women's ability to access reproductive care."
Mifepristone is the first drug in the chemical abortion regimen, which works to destroy the environment in the uterus and starves an unborn baby to death. The abortion pill is reportedly used in about half of all pregnancy terminations in the United States.
In November 2022, the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians & Gynecologists, the Christian Medical & Dental Associations and four individual doctors filed a lawsuit seeking to overturn the FDA's 2000 approval of mifepristone.
The lawsuit also sought to overturn the Biden administration's recent lifting of restrictions, such as allowing the drug to be distributed by mail or sold at retail pharmacies without requiring women to see a doctor first. Previously, the drug was mostly dispensed by certified doctors or clinics.
The pro-life organizations argued that the drug can be dangerous for pregnant women to take when administered outside of a medical environment to women who haven't been screened for ectopic pregnancies or other potential complications that could endanger them.
U.S. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas, a Trump appointee, issued a stay in April of the FDA's 2000 approval of mifepristone, arguing that "FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions."
"There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased 'access' to chemical abortion — which was the 'whole idea of mifepristone,'" continued Kacsmaryk.
Kacsmaryk contends that the FDA's loosening of restrictions "resulted in many deaths and many more severe or life threatening adverse reactions."
Shortly after the stay was granted, a three-judge panel on the U.S. 5th Circuit Court of Appeals partially granted the request of the Biden administration to stop the lower court decision from taking effect.
The appellate court panel overruled the district court's suspension of the FDA's approval of mifepristone, citing a six-year statute of limitations as justification. However, the appellate court upheld Kacsmaryk's striking down of the administration's relaxed requirements for distributing the chemical abortion drug.
On April 21, the Supreme Court released an unsigned ruling allowing the abortion pill to remain on the market during the legal proceedings.
Supreme Court Justices Clarence Thomas and Samuel Alito indicated they would have denied the requests. Alito authored a dissent suggesting that the appellants "are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim."
"The applicants claim that regulatory 'chaos' would occur due to an alleged conflict between the relief awarded in these cases and the relief provided by a decision of the United States District Court for the Eastern District of Washington," Alito wrote.
"It is not clear that there actually is a conflict because the relief in these cases is a stay, not an injunction, but even if there is a conflict, that should not be given any weight."
