The Biden administration and drugmaker Danco Laboratories filed a request Friday appealing a lower court’s decision to strip Food and Drug Administration approval of abortion drug mifepristone. On behalf of the Biden administration, the Department of Justice is taking the appeal to the Supreme Court.
Last week, Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump, blocked the FDA’s approval of mifepristone following a lawsuit by an anti-abortion rights group, claiming the FDA rushed the drug’s approval more than two decades ago and it poses health risks to those who use it.
It was a decision decried by abortion-rights advocates.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement.
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Mifepristone is one of two medications the FDA has approvedto be taken together — one after another — for a medicated abortion. Mifepristone is a one-dose pill only approved for patients up to 10 weeks into a pregnancy, or 70 days.
The Department of Justice said in its filing on behalf of the administration that last week’s ruling would “‘immediately’ render all extant doses of mifepristone misbranded because their labeling would be inconsistent with the operative conditions of approval. The generic version of the drug would cease to be approved altogether. FDA and mifepristone’s sponsor would have to adjust the drug’s labeling to account for the lower courts’ actions — a process that could take months.”
The decision comes as many Republican-led states try to ban or severely restrict access to abortion. The Biden administration has said that abortion pills should still be accessible through the mail.
According to the Guttmacher Institute, which advocates for abortion rights, 98% of medication abortions in the United States in 2020 used the mifepristone and misoprostol combination. As for safety, a 2022 Scripps News investigation found that for every 1 million patients who used mifepristone, 6 and a half patients died, and that the death rate for penicillin is 4 times higher.
Drugmaker Danco said the Fifth Circuit court was flawed in its decision.
