WASHINGTON — A federal judge in Texas revoked the U.S. Food and Drug Administration’s two-decade-old approval of the abortion pill Friday, though he gave the federal government seven days to appeal the case.
U.S. District Court Judge Matthew Joseph Kacsmaryk’s opinion in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, can be found here.
The Friday ruling will not take effect immediately, though if it does, abortion rights organizations have suggested health care providers could use just the second drug, misoprostol, without mifepristone.
“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.
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 lawsuit, filed in mid-November by anti-abortion organizations, argued the FDA “exceeded its regulatory authority” when it approved mifepristone and misoprostol to end pregnancies.
Kacsmaryk’s opinion 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 conservative-leaning 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.
Friday’s ruling overturns the FDA’s 2000 approval of mifepristone, including in states where abortion remains legal following the Supreme Court’s decision last summer to end the nationwide, constitutional right.
Friday’s ruling sides with four anti-abortion groups and four anti-abortion doctors who filed a lawsuit in mid-November arguing the FDA erred in approving mifepristone in 2000. The lawsuit was filed by Alliance Defending Freedom, an anti-abortion legal organization.
Democrats in Congress called for an immediate appeal by the Biden administration.
“Because of today’s lawless ruling by an extremist Republican judge, women across the country could lose access to a safe and legal medication they’ve relied on for decades,” said Sen. Elizabeth Warren of Massachusetts. “Attorney General Garland should quickly appeal this decision in order to preserve access to medication abortion, and I urge the Biden administration to use every legal and regulatory tool in its power to keep this drug available.”
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.”
ADF attorneys wrote in their 113-page lawsuit the FDA “exceeded its regulatory authority” when it approved mifepristone and misoprostol 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.
Erik 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.
That would place a second abortion case with nationwide implications before the same justices that overturned the constitutional right to abortion.
This is a breaking news story and will be updated.