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. “The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v.
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.
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