Biden White House press secretary Karine Jean-Pierre issued a statement lamenting a federal court ruling this week that could block the U.S. Food and Drug Administration’s (FDA) loosened restrictions on mifepristone, the first drug used in a two-drug chemical abortion regimen.
Jean-Pierre claimed Wednesday:
We strongly disagree with today’s ruling from the Fifth Circuit Court of Appeals in Alliance for Hippocratic Medicine v. FDA, which undermines FDA’s scientific, independent judgment and reimposes onerous restrictions on access to safe and effective medication abortion.
A three-judge panel of the conservative U.S. Court of Appeals for the Fifth Circuit ruled that the FDA’s 2016 decision to allow the abortion pill to be taken later in pregnancy 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.
The opinion continues:
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. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.
Despite the court’s ruling against the government and the drug manufacturer, mifepristone will remain available, for now, 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. If the Supreme Court does not take the case, the Fifth Circuit’s order will go into effect.
“Due to the Supreme Court’s stay, mifepristone remains broadly available for now,” the White House statement continued:
But if the Fifth Circuit’s ruling stands, it will significantly roll back the ability for women in every state to get the health care they need, and undermine FDA’s scientific, evidence-based process for approving safe and effective medications that patients rely on.
Jean-Pierre further claimed that the lawsuit “poses an unprecedented threat to the FDA’s authority to review, approve, and set evidence-based requirements for a wide range of safe and effective drugs” and that the Department of Justice (DOJ) is seeking a Supreme Court review on the Fifth Circuit’s ruling. Jean-Pierre added that, regardless, President Joe Biden and Vice President Kamala Harris will continue to be relentless in their efforts to defend ending the lives of unborn babies.
“As our fight continues in the courts, President Biden and Vice President Harris remain firmly committed to defending reproductive health care, and the Administration will continue to stand by FDA’s independent approval of mifepristone as safe and effective,” she said. “In the face of these unprecedented attacks on women’s health, we will continue to fight for women’s freedom to make decisions about their own bodies.”
The Alliance Defending Freedom (ADF) filed the lawsuit in November 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 alleged 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 also 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 also states that the “only way” the agency could have approved chemical abortion drugs “was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments.”
“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs,” the ADF argued.
Mifepristone works by blocking 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 case is Alliance for Hippocratic Medicine v. FDA and Danco Laboratories, No. 23-10362, in the U.S. Court of Appeals for the Fifth Circuit.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on Twitter @thekat_hamilton.