BREAKBREAK,
Judge Matthew Kacsmaryk temporarily suspended FDA approval for mifepristone, which is used in drug-induced abortions.
A federal judge in Texas has temporarily withdrawn approval for the use of mifepristone, one of two pills used for drug-induced abortions, in a ruling that will have major implications for reproductive health care in the United States.
In a victory for anti-abortion advocates, Judge Matthew Kacsmaryk issued a 67-page ruling suspending U.S. Food and Drug Administration (FDA) approval of the mifepristone, which would make the sale of the widely used drug illegal.
The decision gives Democratic President Joe Biden’s administration seven days to appeal before the temporary ban takes effect.
Kacsmaryk’s decision is considered the first time a single judge has overruled the FDA’s medical authority. Shortly after the order was announced, a Washington state judge, Thomas O Rice, issued another ruling that would block “any action to remove mifepristone from the market.”
The withdrawal of mifepristone’s FDA approval comes at the request of plaintiffs in the Texas case, a coalition of anti-abortion medical providers called the Alliance for Hippocratic Medicine. They filed a preliminary injunction to remove mifepristone from the market, filing a lawsuit alleging that the FDA was wrong to approve the drug more than two decades ago.
The case is being heard by a federal court in Amarillo, Texas. The order would last for the duration of the case or until a successful appeal.
Kacsmaryk, an appointee of former Republican President Donald Trump, has yet to rule on the plaintiffs’ overall lawsuit. It alleges that the FDA “failed to meet its legal obligations to protect the health, safety and well-being of women and girls” when it approved mifepristone and called for its removal from the market.
Mifepristone has been available in the US since 2000 and is approved for use in the first 10 weeks of pregnancy, in combination with a second pill, misoprostol. Medical abortion – performed with pills – is now the most common form of abortion in the country.
The Guttmacher Institute estimates that more than half of all abortions in the US were completed with a combination of mifepristone and misoprostol in 2020, up from 39 percent in 2017. It is generally considered safe to use.
Abortions are possible with misoprostol alone, but that drug regimen is not considered effective.
This is an evolving story. More details to to follow.