President Joe Biden did not mince words about a Texas judge’s ruling last week to suspend the FDA’s approval of abortion medication mifepristone.
“It’s completely out of bounds what the judge did,” Biden told reporters on Tuesday ahead of his trip to Belfast, Ireland.
If allowed to stand, the order would restrict access to the drug as soon as Friday. Mifepristone, which has been widely available for more than two decades, is used in the most common method of abortion nationwide.
Biden’s comments about the ruling issued last week by U.S. District Judge Matthew Kacsmaryk, an appointee of his predecessor, Donald Trump, come one day after the Justice Department appealed the decision, calling it “extraordinary and unprecedented.”
“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 Justice Department wrote in its filing asking for an emergency stay to block Kacsmaryk’s ruling.
The FDA approved mifepristone, one of two drugs used for medication abortion in the United States, in 2000. There is no precedent for a single judge overruling the regulator’s medical decisions.
The ruling has sparked outcry from advocates and pharmaceutical industry figures alike, as well as Democrats and even some Republicans.
More than 300 current and former pharmaceutical industry executives signed a letter Monday opposing the ruling, saying it “ignores decades of scientific evidence and legal precedent.” They accused Kacsmaryk of “judicial interference” that sets a “precedent for diminishing FDA’s authority over drug approvals.”
“We cannot stay quiet,” the letter’s signatories wrote. “We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place.”
“Judicial activism will not stop here,” the letter reads. “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.”
Other Biden administration officials expressed similar concerns.
White House Press Secretary Karine Jean-Pierre slammed the ruling at a press briefing on Monday, calling it an “attack on FDA authority” that could open the floodgates for other medications to be targeted and denied to people who need them.”
Health and Human Services Secretary Xavier Becerra said Sunday that “when you turn upside down the entire FDA approval process, you’re not talking about just mifepristone, you’re talking about every kind of drug.”
“You’re talking about our vaccines, you’re talking about insulin, you’re talking about the new Alzheimer’s drugs that may come on,” he said Sunday on CNN. “If a judge decides to substitute his preference, his personal opinion for that of scientists and medical professionals, what drug isn’t subject to some kind of legal challenge?”
Adding to the uncertainty was a Washington state judge’s ruling issued minutes after Kacsmaryk’s decision, which ordered federal authorities not to make any changes that could restrict access to the drug. The competing rulings could force an expedited review by the Supreme Court, which undid the 50-year-old precedent of Roe v. Wade last year.
Some lawmakers on both sides of the aisle — ranging from progressive Rep. Alexandria Ocasio-Cortez, D-N.Y., to Republican Rep. Nancy Mace of South Carolina — have even called on the Biden administration to ignore the judge’s ruling.
“This is an FDA approved drug,” Mace, who has called for some moderation on abortion restrictions, said on CNN on Monday. “Whether you agree with its usage or not, that’s not your decision. That is the FDA’s decision.”
“I believe that the Biden administration should ignore this ruling,” Ocasio-Cortez told CNN, calling it “an unprecedented and dramatic erosion of the legitimacy of the courts.”
A pair of Republican lawmakers representing New York criticized the ruling in statements to Spectrum News, with one calling it a “dangerous precedent” for a federal judge to set.
“I think this is a dangerous precedent for a federal district court,” Rep. Marc Molinaro said. “I supported expanding access to this medication as a member of the State Assembly and support access now.”
“I am deeply concerned with a U.S. District Court judge’s recent decision to block access to an FDA approved medication key to safeguarding women’s health, and I am currently reviewing ways Congress can best ensure women’s care is not interrupted by this ruling,” said fellow New York GOP Rep. Anthony D’Esposito.
Some Democratic governors, including those in California, Massachusetts and Washington state, have started stockpiling abortion medication amid fears of the court’s ruling.
Spectrum News’ Kevin Frey, Joseph Konig and The Associated Press contributed to this report.
