Federal judge orders abortion pill off U.S. market but immediate appeal expected
The FDA approved mifepristone under the brand-name Mifeprex in 2000, and an abortion-drug regimen that has seen few deaths and a low rate of adverse events in more than two decades of use. (Peter Dazeley/GettyImages)
WASHINGTON — A federal judge in Texas revoked the U.S. Food and Drug Administration’s two-decade-old approval of the abortion pill Friday, and gave the federal government seven days to appeal the case.
Judge Matthew Joseph Kacsmaryk, from the U.S. District Court for the Northern District of Texas, issued a nationwide ruling in the case before his court, though his ruling will not take effect until at least a week from Friday.
The Texas judge’s opinion, however, wasn’t the only ruling on medication abortion released Friday night.
A federal judge in Washington state released a separate opinion telling the FDA it cannot alter “the status quo and rights as it relates to the availability of Mifepristone” in the 16 states that filed a lawsuit in that court.
The contrasting rulings are likely to sow confusion about when and how health care providers can dispense the abortion pill, mifepristone, increasing the odds both cases make their way rapidly to the U.S. Supreme Court.
Judge Thomas Rice, from the U.S. District Court for the Eastern District of Washington, ordered the FDA not to substantially change access to mifepristone in Arizona, Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.
Rice was nominated by President Barack Obama while Kacsmaryk was nominated by President Donald Trump. The U.S. Senate confirmed Rice following a 93-4 bipartisan vote while Kacsmaryk was confirmed on a 52-46 mostly party-line vote.
Kacsmaryk’s opinion in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, can be found here.
If Kacsmaryk’s ruling does take effect amid the appeals process, abortion rights organizations have suggested health care providers could use just the second drug in the medication abortion process, misoprostol, without mifepristone.
Medication abortion, a two-step regimen, is used in more than half of pregnancy terminations in the United States, according to the Guttmacher Institute.
The medication is approved up to 10 weeks into a pregnancy, though it was originally approved in 2000 for up to seven weeks.
The Texas lawsuit, filed in mid-November by anti-abortion organizations and argued by Alliance Defending Freedom, argued the FDA “exceeded its regulatory authority” when it approved mifepristone and misoprostol to end pregnancies.
Kacsmaryk sided with those organizations in his Friday ruling.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
“There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion — which was the ‘whole idea of mifepristone,’” Kacsmaryk added.
Kacsmaryk’s opinion in the Texas case is expected to start an appeals process that will next go to the conservative-leaning 5th Circuit Court of Appeals in New Orleans before likely ending at the U.S. Supreme Court.
That would place a second abortion case with nationwide implications before the same Supreme Court justices who overturned the constitutional right to abortion in 2022.
Democrats in Congress called for an immediate appeal of the Texas ruling by the Biden administration.
New Jersey Democratic Rep. Frank Pallone, ranking member on the U.S. House Energy and Commerce Committee, said the “unprecedented decision must be immediately appealed and overturned.”
“A single right-wing judge should not be able to abolish decades of peer reviewed scientific evidence on the safety of a medication,” Pallone said. “This decision creates a dangerous precedent that attempts to undermine FDA’s drug approval process and furthers Republican efforts to dictate their ideological views to our nation’s public health agencies.”
Minnesota Democratic Sen. Tina Smith said she was “furious” with the ruling.
“This is nothing but an extremist, anti-democratic national abortion ban,” Smith wrote on Twitter. “This outrageous decision would do irreparable harm to women’s health. It’s a blatant attack on our freedom and it cannot be allowed to stand.”
Senate Majority Leader Chuck Schumer of New York said the ruling is “another massive step towards Republicans’ goal of a nationwide abortion ban and could throw our country into chaos. Rightwing activists sought out an extremist judge who is vehement in his desire to take women’s rights away.”
“This ruling from an activist judge is wildly out of step with the law and sets a dangerous new precedent,” Schumer said. “Senate Democrats are relentlessly working to protect a woman’s right to choose from this extreme MAGA Republican agenda. We are committed to passing the Women’s Health Protection Act to enshrine the right to choose into law, ensuring mifepristone remains available in pharmacies, protecting health data around abortion, and much more.”
Alliance Defending Freedom Senior Counsel Erik Baptist said the Texas ruling would protect women and girls.
“The FDA never had the authority to approve these hazardous drugs and remove important safeguards,” Baptist said. “This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls.”
ADF attorneys wrote in their 113-page lawsuit that was filed in mid-November that the FDA “exceeded its regulatory authority” when it approved mifepristone to end pregnancies.
They also questioned the safety and efficacy of the abortion pill, a claim that was strongly refuted by medical organizations.
The American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Maternal-Fetal Medicine and the American Academy of Family Physicians, among others, wrote in court documents that the abortion pill is safe and effective.
“Serious side effects occur in less than 1% of patients, and major adverse events — significant infection, blood loss, or hospitalization — occur in less than 0.3% of patients,” the medical groups wrote. “The risk of death is almost non-existent.”
The medical groups noted that mifepristone’s “safety profile is on par with common painkillers like ibuprofen and acetaminophen, which more than 30 million Americans take in any given day.”
“There is a greater risk of complications or mortality for procedures like wisdom tooth removal, cancer-screening, colonoscopy, plastic surgery, and the use of Viagra than by any abortion method (medication or procedural),” they wrote.
Attorneys for the federal government argued in a 52-page response to the lawsuit that pulling an FDA-approved medication off the market after more than two decades would be “extraordinary and unprecedented.”
“Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay,” wrote attorneys for the U.S. Justice Department.
Kacsmaryk held a four-hour hearing in mid-March where attorneys for ADF and the Department of Justice had two hours each to present their case. He declined to livestream the hearing or allow audio recordings.
Baptist, senior counsel at Alliance Defending Freedom, argued during the hearing the FDA’s approval of mifepristone under a fast-track process known as Subpart H was improper, according to the Texas Tribune.
Kacsmaryk listed the HIV and cancer drugs approved under that designation before the FDA approved mifepristone, then noted that ADF was asking him to “deem one of these not like the others,” according to the Tribune.
Lawyers for the DOJ contended the statute of limitations on the anti-abortion organizations complaints had expired “and they have not satisfied the requirements to reopen the FDA’s approval of mifepristone,” according to the Tribune.
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