The administration of US President Joe Biden has filed an emergency motion to suspend a decision that would suspend sales of the abortion pill mifepristone, as part of an ongoing legal dispute that could affect access to reproductive health care for millions of Americans.
The U.S. Department of Justice (DOJ) filed the motion in an appeals court on Monday, stating that last Friday’s ruling by conservative Justice Matthew Kacsmaryk undermined the Food and Drug Administration’s (FDA) ability to establish the safety of drugs. couples and refusing women would undermine. access to abortion pills.
The court’s sweeping nationwide relief was especially unwarranted given the balance of harm: If enacted, the court’s order would thwart the FDA’s scientific judgment and seriously harm women, especially those for whom mifepristone is a medical or practical necessity,” the DOJ stated. .
Kacsmaryk’s ruling on Friday granted a temporary injunction to sell mifepristone while a case over the drug’s FDA approval was considered. That order would take effect seven days after Friday’s ruling, allowing time for an appeal.
At 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 the authority of the FDA. She also expressed the Biden administration’s support for the DOJ’s appeal.
“It’s probably going to the Supreme Court, which we’re pretty sure we’re going to win,” said Jean-Pierre. “We stand by the FDA’s approval of mifepristone and we are prepared for a long legal battle.”
Jean-Pierre also resisted 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 legal basis and will ban the most common method of abortion in EVERY single state,” Wyden tweeted Friday, calling on the Biden administration to take strong action to override the ruling.
But Jean-Pierre responded Monday that ignoring a court decision would set a “dangerous precedent,” echoing a statement made by U.S. Department of Health and Human Services (HHS) spokesman Kamara Jones on Sunday.
This devastating ruling has no legal basis and will ban the most common method of abortion in EVERY state.
President Biden can and must ignore this ruling and keep mifepristone on the market and accessible to every woman in America.
— Ron Wyden (@RonWyden) April 7, 2023
Mifepristone was approved by the FDA in 2000 as the first of two pills used in drug-induced abortion, along with the drug misoprostol.
There is strong scientific consensus that the pills are safe to use, and they are responsible for more than half of all abortions in the US. Mifepristone is also used to treat Cushing’s syndrome and misoprostol to prevent ulcers.
Push to restrict access to abortion pills like 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 abortion in the US to make.
Since Roe was reversed, numerous Republican-led states have passed abortion bans and other laws that would make access to the procedure more difficult.
Another federal judge in Washington state issued a decision shortly after Kacsmaryk’s ruling on Friday that would block “any action to remove mifepristone from the market.” Those conflicting rulings increase the likelihood that the case will eventually end up in the US Supreme Court.
People are rightly frustrated with this decision — but as dangerous as it is for a court to override an FDA expert’s verdict on a drug’s safety and efficacy, it would also set a dangerous precedent for the government to binding decision.
— Kamara Jones (Acting ASPA) (@HHS_Spox) April 9, 2023
Health experts say the case could also have implications for the scientific assessment of drug safety and medicines more broadly.
On Monday, a group of more than 300 biotech and pharmaceutical company leaders released an open letter calling for the decision to be reversed, saying the ruling ignores decades of scientific evidence and undermines the FDA’s authority.
“Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing[the]FDA’s authority over drug approval, thereby creating uncertainty for the entire biopharmaceutical industry,” said the letter, which was signed by high-profile figures, including Pfizer Inc CEO Albert Bourla.
“Legal activism will not stop here,” it continued. “If courts can overturn drug approvals without regard to science or evidence, or the complexity required to fully investigate the safety and efficacy of new drugs, any drug risks having the same outcome as mifepristone.”
