Supreme Court questions Biden administration's loosening of abortion pill restrictions

The US Supreme Court came one step closer to issuing another abortion ruling as it considered the Biden administration's loosening of restrictions on the abortion pill on Tuesday, questioning whether courts can second-guess government expert decisions.

The judges held oral arguments in the case of FDA v. Alliance for Hippocratic Medicine, based on a lawsuit filed in the US 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 US Food and Drug Administration's removal of personal dispensing requirements for mifepristone in 2021 and its 2016 decision to allow medical professionals other than doctors to dispense and prescribe the drug.

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Further changes made in 2016 enabled the FDA to stop reporting non-fatal complications of the abortion pill and allowed women to take the drug up to 10 weeks into pregnancy as opposed to seven.

Last spring, Judge Matthew Kacsmaryk, a Trump pick, sided with the plaintiffs by striking down the FDA's approval of the chemical abortion pill marketed as mifepristone in the United States. The synthetic steroid endocrine disruptor essentially destroys the environment in the womb and starves an unborn baby to. death

The 5th US Circuit Court of Appeals upheld the lower court decision removing 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 US government is asking the judges to overturn the decision.

US Attorney General Elizabeth Prelogar defended the administration's relaxation of delivery requirements. In her opening statement, she said that “reversing FDA's changes will unnecessarily limit access to mifepristone without safety justification.”

“Some women might be forced to undergo surgical abortions. Others might not be able to access the drug at all,” she added, rejecting the idea that the abortion pill puts women at risk of serious complications.

“Only an exceptionally small number of women suffer such serious complications that could trigger any need for emergency treatment,” she said.

“There is no basis to conclude that any of this 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 relaxation of requirements for the abortion pill.

Supreme Court Justice Samuel Alito, one of the conservative members of the court, suggested that Prelogar made the case that “it doesn't matter if the FDA flagrantly violated the law and failed to do what it should have done, endangered women's health. , that's just a shame, no one can sue.”

After questioning Jessica Ellsworth, the lawyer for the abortion pill manufacturer Danco Laboratories, also a party in the lawsuit, Alito asked her to describe how the company was “affected 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 yes.

“The Fifth Circuit decision doesn't prohibit you from continuing to make and sell that product, does it?” he asked. After Ellsworth acknowledged that Alito's analysis was correct, he continued, “I gather that your injury is that you think you would sell more if the restrictions that were previously in place were lifted.”

“The injury is that we are prevented from selling our product in accordance with FDA's scientific judgment regarding the safe and effective use of the drug,” she replied.

Picking up the line of questioning with Prelogar, Alito asked if Ellsworth viewed the FDA as an “infallible authority.” She indicated that she did not but said it would be different if plaintiffs presented patients suffering from such adverse effects.

Judge Ketanji Brown Jackson returned to the question of the FDA being “infallible,” asking Ellsworth if she thought “courts have specialized scientific knowledge with respect to pharmaceuticals” and “as a company that has pharmaceuticals, do you have concerns about judges analyzing medical and scientific studies?”

Ellsworth said she shared Jackson's concerns and accused the district court of relying on flawed science.

In his ruling last year, Kacsmaryk accused the FDA of having “acquiesced to its legitimate safety concerns … based on clearly weak reasoning and studies that did not support its conclusions.” Kacsmaryk also wrote that the FDA faced “significant political pressure to waive its proposed safety precautions to better advance the policy goal of increased 'access' to chemical abortion.”

Ellsworth said Kacsmaryk relied on “one study, which was an analysis of anonymous blog posts.”

“You have another set of studies that he relied on that were not in the administrative file,” she said.

Claiming 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 freedom law firm Alliance Defending Freedom, claimed that the FDA “admits 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 'inadequate,'” characterizing the agency's actions as a violation of the Administrative Procedure Act.

Jackson engaged in a similar line of questioning with Hawley, discussing efforts to engage in what she characterized as “second guessing” by the FDA.

The newest member of the Supreme Court asked, “What deference, if any, do courts owe the opinion of the expert regarding the safety and effectiveness of drugs?”

“We are not asking the court to second guess the agency determinations at all,” Hawley responded, criticizing the lack of transparency behind agency determinations.

“These proceedings continue 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 claimed that the FDA's allowing the abortion pill to be sent through the mail violated federal law.

“We don't think there is any case from this court that authorizes FDA to ignore another federal law,” she said. “Regarding the Comstock Act, as relevant here, the Comstock Act says that drugs should not be sent … 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. The decision will mark the second time in the past two years that the court has issued a significant ruling on abortion.

In 2022, the Supreme Court gave its important decision in Dobbs v. Jackson Women's Health Organization, which determined that the American constitution does not contain a right to abortion.


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