The status of the abortion pill was thrown into doubt after a federal judge temporarily blocked the Food and Drug Administration’s approval of mifepristone, only to have the order countered by another federal judge.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee based in Amarillo, Texas, signed an injunction Friday staying the FDA’s 2000 approval of the drug pending the outcome of a lawsuit filed by pro-life doctors represented by the Alliance Defending Freedom.
He was promptly contradicted by U.S. District Judge Thomas O. Rice, an Obama appointee in Spokane, Washington, who blocked the FDA from making any changes to the drug’s access in the 17 states and District of Columbia.
Those jurisdictions sought a preliminary injunction affirming the agency’s “original conclusion that mifepristone is safe and effective.”
Judge Rice rejected their request to apply the injunction nationwide, saying that abortion restrictions “vary state-by-state and Plaintiffs allege harm not shared nationwide.”
The conflicting orders heightened the drama surrounding the legal battle over mifepristone, one of two drugs used in the abortion-pill regimen, now the most popular method of pregnancy termination in the nation.
Judge Kacsmaryk acknowledged that the FDA approved mifepristone 23 years ago, asking: “Why did it take two decades for judicial review in federal court?” He then answered his own question.
“Simply put, FDA stonewalled judicial review—until now,” said the judge in the 67-page ruling. “Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within ‘180 days of receipt of the petition.’”
He said the case would have been settled in court decades earlier, but instead, “FDA postponed and procrastinated for nearly 6,000 days.”
Judge Kacsmaryk said his order temporarily blocking the FDA approval does not go into effect for seven days, allowing the Biden administration an opportunity to seek review from appellate courts.
Pro-life groups cheered the Texas-based judge’s decision in the lawsuit, which was filed by the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, and other pro-life medical organizations and doctors.
“The FDA never had the authority to approve these hazardous drugs and remove important safeguards,” said ADF senior counsel Erik Baptist. “This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”
March for Life president Jeanne Mancini said the “court’s decision today is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs.”
BREAKING: A federal judge has stayed the approval of mifepristone, the chemical abortion pill that the FDA approved in 2000 without going through any appropriate safety evaluations.
— Kristan Hawkins (@KristanHawkins) April 7, 2023
In 7 days, chemical abortion pills will not be legal in the US, protecting women and children. pic.twitter.com/BV27r0tpzZ
Meanwhile, Sen. Ron Wyden, Oregon Democrat, called on the FDA to “ignore the ruling” by the Texas judge.
“There is no way this decision has a basis in law,” said Mr. Wyden. “It is instead rooted in conservatives’ dangerous and undemocratic takeover of our country’s institutions.”
The pro-choice group UltraViolet urged the Biden administration to challenge the temporary injunction.
“The Biden administration must appeal this decision to the 5th Circuit Court immediately,” said UltraViolet executive director Shaunna Thomas. “Upon appeal, we urge the Fifth Circuit to remedy today’s ruling by ensuring access to this FDA approved medication.”
The FDA has approved the abortion-pill regimen for pregnancies through 10 weeks’ gestation.
In December, the agency made permanent pandemic-era rules allowing the pills to be prescribed via telehealth and delivered by mail. Certified retail pharmacies have also been permitted to dispense prescriptions by mail.
Maryland Attorney General Anthony Brown called the Texas judge’s injunction “an attack on reproductive freedom” but emphasized that “mifepristone remains available in Maryland.”
“Thankfully, even as the ruling in Texas threatened reproductive freedom, the Court in our case in the Eastern District of Washington preserved access to mifepristone in Maryland and the other states that joined the lawsuit,” said Mr. Brown.
Rep. Chris Smith, New Jersey Republican and chair of the Congressional Pro-Life Caucus, said the FDA has “blatantly ignored warnings of life-threatening complications associated with mifepristone and misoprostol,” the two drugs in the protocol.
“While the FDA has enabled the abortion industry to prey on women and girls during their most vulnerable moments of need, today’s decision finally puts the health of women first—protecting them from the known and unknown risks of chemical abortion,” said Mr. Smith.
• Valerie Richardson can be reached at vrichardson@washingtontimes.com.
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