The Supreme Court announced Wednesday that it has decided to hear a case about the U.S. Food and Drug Administration (FDA) rolling back safety restrictions around mifepristone, the first drug used in a two-drug medication abortion regimen.
In September, both President Joe Biden’s Department of Justice (DOJ) and Danco Laboratories LLC, which distributes mifepristone under the brand name Mifeprex, asked the Supreme Court to reverse a lower court decision halting two FDA actions that loosened restrictions around the abortion pill. The Supreme Court ultimately granted a hearing to both cases, consolidating them into one with a total of one hour allotted for oral argument.
“This Administration will continue to stand by FDA’s independent approval and regulation of mifepristone as safe and effective. 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,” White House Press Secretary Karine Jean Pierre said in response. ” We continue to urge Congress to pass a law restoring the protections of Roe v. Wade — the only way to ensure the right to choose for women in every state.”
Biden’s DOJ and Danco Laboratories appealed an August ruling from the U.S. Court of Fifth Circuit, which found that the FDA’s 2016 decision to allow the abortion pill to be taken up to ten weeks of pregnancy instead of seven weeks is unlawful. The court said the same of the FDA’s 2021 rule change, which allowed the abortion pill to be mailed directly to patients and allowed medical professionals other than doctors to prescribe mifepristone.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” reads the panel opinion, penned by Judge Jennifer Walker Elrod.
“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the opinion continued. “And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
Elrod wrote that at the preliminary stage, plaintiffs “have made a substantial showing” that the 2016 and 2021 rule changes violate the Administrative Procedure Act (APA).
Despite the Fifth Circuit’s ruling against the government and the drug manufacturer, mifepristone has remained available under existing regulations while the litigation continues. The Supreme Court preemptively paused any ruling from an appeals court this spring, pending a petition for the Supreme Court to take the case.
The Alliance Defending Freedom (ADF) filed the lawsuit in November of 2022 against the FDA on behalf of four national medical associations and several doctors, alleging the agency “chose politics over science and approved chemical abortion drugs for use in the United States.”
The lawsuit points to six discrete agency actions since the legalization of mifepristone and misoprostol in 2000. The ADF alleges that the agency was only able to approve the drug by falsely classifying pregnancy as an “illness.” The lawsuit also alleges that the FDA never studied the safety of mifepristone under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded evidence that chemical abortion drugs cause more complications than surgical abortion, and eliminated necessary safeguards for pregnant girls and women who take the regimen.
The lawsuit additionally details how, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take the abortion drugs — from seven weeks gestation to ten weeks gestation. Then, in 2021, the FDA allowed abortionists to send mifepristone through the mail, which the ADF says was “in direct violation of federal law.” The FDA recently made permanent its rule to allow women and girls to receive a prescription for mifepristone via telemedicine.
The complaint alleges:
All of the FDA’s actions on chemical abortion drugs — the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement — failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier. Instead, the FDA’s actions permitted and sometimes even encouraged these illegal activities.
The Fifth Circuit took up the case after U.S. District Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas handed down a 67-page decision that the FDA’s decisions were illegal under federal law, issuing a nationwide injunction blocking the abortion pill.
Days later, the U.S. Court of Appeals for the Fifth Circuit partially granted a stay requested by the Biden Justice Department. The court’s 42-page opinion temporarily put on hold the part of the decision about the 2000 FDA decision because it might be past the deadline for bringing legal challenges, though added that it was a “close call” and that the court might go the opposite direction after receiving additional legal arguments. But the appellate court rejected a stay on anything from 2016 to the present, affirming the trial court’s injunction.
The Supreme Court then put a hold on Kacsmaryk’s entire decision. As Breitbart News previously noted, an administrative stay is not in any way a reflection on the legal merits of the case. A Supreme Court justice can issue one just to preserve the status quo while the court is receiving arguments from both sides.
ADF Senior Counsel Erin Hawley released a statement on Wednesday accusing the FDA of making a “politically driven decision” pushing chemical abortions.
“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions. We urge the Supreme Court to do the same. The FDA has harmed the health of women and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen,” Hawley said.
“Like any federal agency, the FDA must rationally explain its decisions. Yet its removal of common-sense safeguards — like a doctor’s visit before women are prescribed chemical abortion drugs — does not reflect scientific judgment but rather a politically driven decision to push a dangerous drug regimen,” she continued.
The Supreme Court declined to take up an appeal from the ADF asking justices to rule on the legality of the FDA’s 2000 approval of mifepristone.
According to former abortionist Dr. Anthony Levatino, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
The pro-abortion Guttmacher Institute found that mifepristone is used for more than half of all abortions in the United States. In 2020, the drug accounted for 53 percent of all abortions, up from 39 percent in 2017.
The Biden administration has relentlessly promoted medication abortions, and in January, the FDA allowed retail pharmacies to dispense abortion pills. At the same time, several Democrat governors have stockpiled abortion pills while enacting shield laws that protect health care providers who prescribe mifepristone to women and girls in states with laws protecting the unborn.
The case is FDA v. Alliance for Hippocratic Medicine, No. 23-235 in the Supreme Court of the United States.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.