Supreme Court questions Biden admin.'s loosening of abortion pill restrictions
The U.S. Supreme Court came one step closer to issuing another abortion decision as it pondered the Biden administration's loosening of restrictions on the abortion pill on Tuesday, questioning if courts can second guess government expert determinations.
The justices held oral arguments in the case of FDA v. Alliance for Hippocratic Medicine, based on a lawsuit filed in the U.S. District Court for the Northern District of Texas Amarillo Division in late 2022 by pro-life medical organizations and professionals.
The case centers around the U.S. Food and Drug Administration's removal of in-person dispensing requirements for mifepristone in 2021 and its 2016 decision to enable medical professionals other than doctors to dispense and prescribe the drug.
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Additional changes made in 2016 enabled the FDA to stop reporting non-fatal complications from the abortion pill and allowed women to take the drug as late as 10 weeks into pregnancy as opposed to seven.
Last spring, Judge Matthew Kacsmaryk, a Trump appointee, sided with the plaintiffs by striking down the FDA's approval of the chemical abortion pill marketed as mifepristone in the U.S. The synthetic steroid endocrine disruptor essentially destroys the environment in the uterus and starves an unborn baby to death.
The 5th U.S. Circuit Court of Appeals upheld the lower court decision striking down the relaxed requirements for the abortion pill while putting on hold the aspect of the decision striking down the FDA's 2000 approval of the abortion pill altogether. The U.S. government is asking the justices to reverse the decision.
U.S. Solicitor General Elizabeth Prelogar defended the administration's loosening of dispensing requirements. In her opening statement, she said that "rolling back FDA's changes would unnecessarily restrict access to mifepristone with no safety justification."
"Some women could be forced to undergo surgical abortions. Others might not be able to access the drug at all," she added, dismissing the idea that the abortion pill puts women at risk of serious complications.
"Only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment," she said.
"There is no basis to conclude that any of that would be traceable to the incremental changes that FDA made in 2016 and 2021 as opposed to the availability of mifepristone in general."
Prelogar insisted that the plaintiffs did not have standing to bring the lawsuit because they have "no certain injury of their own" as a result of the loosening of requirements for the abortion pill.
Supreme Court Justice Samuel Alito, one of the court's conservative members, suggested that Prelogar was making the case that "it doesn't matter if the FDA flagrantly violated the law and didn't do what it should have done, endangered the health of women, that's just too bad, nobody can sue."
When questioning Jessica Ellsworth, the attorney for the abortion pill manufacturer Danco Laboratories, also a party in the lawsuit, Alito asked her to describe how the company was "aggrieved by the challenge that is brought in this case." He asked Ellsworth if mifepristone was the only product her company was currently marketing, and she answered in the affirmative.
"The Fifth Circuit decision does not prohibit you from continuing to produce and sell that product, right?" he asked. After Ellsworth acknowledged that Alito's analysis was correct, he followed up, "I gather your injury is that you think you're going to sell more if the restrictions that previously were in place were lifted."
"The injury is that we are prevented from selling our product in line with FDA's scientific judgment about the safe and efficacious use of the drug," she responded.
Picking up on the line of questioning with Prelogar, Alito inquired whether Ellsworth viewed the FDA as "infallible." She indicated that she did not but said that it would be different if plaintiffs presented patients suffering from such adverse effects.
Justice Ketanji Brown Jackson circled back to the question about the FDA being "infallible," asking Ellsworth whether she thought "courts have specialized scientific knowledge with respect to pharmaceuticals" and "as a company that has pharmaceuticals, do you have concerns about judges parsing medical and scientific studies?"
Ellsworth said she shared Jackson's concerns and accused the district court decision of relying on faulty science.
In his ruling last year, Kacsmaryk accused the FDA of having "acquiesced on its legitimate safety concerns ... based on plainly unsound reasoning and studies that did not support its conclusions." Kacsmaryk also wrote that the FDA faced "significant political pressure to forego its proposed safety precautions to better advance the political objective of increased 'access' to chemical abortion."
Ellsworth said Kacsmaryk relied on "one study that was an analysis of anonymous blog posts."
"You have another set of studies that he relied on that were not in the administrative record," she said.
Contending that judges were "not experts in statistics" or "the methodology used for scientific studies for clinical trials," Ellsworth reiterated the point made throughout the arguments that courts should not "second guess" FDA data on the matter.
Erin Hawley, an attorney with the religious liberty law firm Alliance Defending Freedom, maintained that the FDA "concedes that between 2.9 and 4.6% of women will end up in the emergency room" after taking the abortion pill. She said, "Women are even more likely to need surgical intervention and other medical care without an in-person visit."
Hawley stated that "FDA approved abortion by mail based on data it admitted was 'not adequate,'" characterizing the agency's actions as a violation of the Administrative Procedure Act.
Jackson engaged in a similar line of questioning with Hawley, taking issue with efforts to engage in what she characterized as "second guessing" of the FDA.
The newest member of the Supreme Court asked, "What deference, if any, do courts owe the opinion of the expert concerning the safety and efficacy of drugs?"
"We're not asking that the court second guess the agency determinations at all," Hawley replied, criticizing the lack of transparency behind agency determinations.
"These proceedings go on between Danco and the FDA behind closed doors," she said. "This is not a notice and comment process."
During an exchange with Justice Clarence Thomas, Hawley alleged that the FDA's allowing the abortion pill to be sent through the mail violated federal law.
"We don't think that there's any case of this court that empowers FDA to ignore other federal law," she said. "With respect to the Comstock Act, as relevant here, the Comstock Act says that drugs should not be mailed … either through the mail or through common carriers."
The Supreme Court is expected to rule on the case before the end of its current term this summer. A decision will mark the second time in the past two years the court has issued a significant ruling on abortion.
In 2022, the Supreme Court handed down its landmark decision in Dobbs v. Jackson Women's Health Organization, which determined that the U.S. Constitution does not contain a right to abortion.
Ryan Foley is a reporter for The Christian Post. He can be reached at: [email protected]
