The Justice Department filed an emergency motion in a federal appeals court on Monday to overturn a judge’s ruling last week that would suspend access to the abortion drug mifepristone nationwide.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, on Friday ordered a pause until the FDA’s approval of mifepristone, which is used along with the drug misoprostol to terminate a pregnancy within the first 70 days. Kacsmaryk gave the federal government seven days to seek emergency relief from the U.S. Court of Appeals for the Fifth Circuit.
Lawyers from the Ministry of Justice called that ruling “extraordinary and unprecedented” in their appeal on Monday.
Plaintiffs have no authority to challenge FDA’s approval of a drug they do not use or prescribe; their challenge to FDA actions dating back to 2000 is clearly premature; and they have provided no basis for questioning scientific judgment of the FDA,” the lawyers wrote. “If it goes into effect, that order will cause irreparable damage to patients, healthcare systems and businesses.”
Mifepristone (Mifeprex) and Misoprostol, the two medications used in a drug-induced abortion, are seen June 17, 2022 at the Women’s Reproductive Clinic, which provides legal drug-induced abortion services, in Santa Teresa, New Mexico. (ROBYN BECK/AFP via Getty Images)
Lawyers asked the appeals court to stay Kacsmaryk’s ruling while the matter works its way through the courts. It will likely end with the Supreme Court, which last year overturned Roe V. Wade and returned abortion restrictions to the states.
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Separately, Obama-appointed U.S. District Judge Thomas Rice issued a preliminary injunction on Friday preventing the FDA from “altering” the current availability of mifepristone in several Democratic-led states. Attorneys general for those states had sued the health department earlier this year, arguing that mifepristone is “safer than many other commonly used drugs regulated by the FDA, such as Viagra and Tylenol.”
The Biden administration was quick to condemn Kacsmaryk’s ruling, with Health Secretary Xavier Becerra suggesting that the FDA could ignore Kacsmaryk’s ruling altogether.
Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15, 2023. (MOISES AVILA/AFP via Getty Images)
A spokesperson for the Department of Health and Human Services retracted that statement on Sunday.
“People are rightfully frustrated with this decision — but as a dangerous precedent it sets for a court to override the FDA’s verdict on a drug’s safety and efficacy, it would also set a dangerous precedent for the government to binding decision,” Department of Health and Human Services spokesperson Kamara Jones tweeted Sunday.
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More than 300 biotech and pharmaceutical industry executives signed an open letter on Monday calling for a retraction of Kacsmaryk’s ruling.
“We call for the reversal of this decision to disregard science, and the appropriate return of the mandate for the safety and efficacy of drugs for all to the FDA, the agency entrusted with this in the first place,” the authors wrote. executives.
