The administration of United States President Joe Biden has filed an emergency motion to stay a decision that would suspend the sale of the abortion pill mifepristone, as part of an ongoing legal dispute that could affect access to reproductive healthcare for millions of Americans.
The US Department of Justice (DOJ) filed the motion in an appeals court on Monday, stating that last Friday’s ruling by conservative Judge Matthew Kacsmaryk would undermine the ability of the Food and Drug Administration (FDA) to determine the safety of medications and deny women access to abortion pills.
“The court’s sweeping nationwide relief was especially unwarranted given the balance of harms: If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the DOJ stated.
Kacsmaryk’s ruling on Friday granted a temporary injunction on the sale of mifepristone, while a case over the FDA’s approval of the drug was heard. That injunction was scheduled to take effect seven days after Friday’s ruling, to allow time for an appeal.
In a press conference on Monday, White House Press Secretary Karine Jean-Pierre denounced Friday’s ruling as a “dangerous” attack on women’s rights and FDA authority. She also articulated the Biden administration’s support for the DOJ’s appeal.
“It probably is going to go up to the Supreme Court, which we feel pretty confident that we’re going to win,” Jean-Pierre said. “We stand by the FDA’s approval of mifepristone, and we are prepared for a long legal fight.”
Jean-Pierre also pushed back against criticism from within the Democratic Party. Several members, including New York Representative Alexandria Ocasio-Cortez and Oregon Senator Ron Wyden, have called on the Biden administration to “ignore” Friday’s ruling.
“This devastating ruling has no basis in law and will ban the most common method of abortion in EVERY single state,” Wyden tweeted on Friday, calling on the Biden administration to take strong action to override the ruling.
But Jean-Pierre responded on Monday that disregarding a court decision would set a “dangerous precedent”, echoing a statement that US Department of Health and Human Services (HHS) spokesperson Kamara Jones made on Sunday.
This devastating ruling has no basis in law and will ban the most common method of abortion in EVERY single state.
President Biden can and must ignore this ruling and keep mifepristone on the market and accessible for every woman in America. https://t.co/g5fyYI4zkr
— Ron Wyden (@RonWyden) April 7, 2023
Mifepristone was approved by the FDA in 2000 as the first of two pills used in medication abortion, along with the drug misoprostol.
There is a strong scientific consensus that the pills are safe to use, and they account for more than half of all abortions in the US. Mifepristone is also used to treat Cushing’s syndrome, and misoprostol to prevent ulcers.
The push to restrict access to abortion pills such as mifepristone has become a focus of anti-abortion groups following a decision last June by the US Supreme Court to overturn Roe v Wade, a 1973 case that established the right to an abortion in the US.
Since Roe was reversed, numerous Republican-led states have passed abortion bans and other laws that would make the procedure harder to access.
Another federal judge in the state of Washington issued a decision that would block “any action to remove mifepristone from the market” shortly after Kacsmaryk’s ruling on Friday. Those conflicting rulings increase the likelihood that the case could ultimately make its way to the US Supreme Court.
People are rightly frustrated about this decision — but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision.
— Kamara Jones (Acting ASPA) (@HHS_Spox) April 9, 2023
Already, some Democrat-led states, including Massachusetts and Washington, have announced that they would build emergency stockpiles of abortion medication.
California Governor Gavin Newsom posted on Twitter on Monday that his state had “secured up to 2 million pills” of misoprostol to ensure continued abortion access.
Health experts say the case could also have implications for the scientific assessment of the safety of drugs and medications more widely.
On Monday, a group of more than 300 biotech and pharmaceutical company leaders released an open letter calling for the decision to be reversed, stating that the ruling ignores decades of scientific evidence and undermines the authority of the FDA.
“Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing [the] FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry,” said the letter, which was signed by high-profile figures including the CEO of Pfizer Inc, Albert Bourla.
“Judicial activism will not stop here,” it continued. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
