
08/01/2024
Kacsmaryk ruled in favor of the plaintiff in a 2022 lawsuit from a group of anti-abortion rights groups called the Alliance for Hippocratic Medicine who sued the FDA in 2022. The plaintiffs in the Texas case are also targeting misoprostol, which is used to treat multiple medical conditions including stomach ulcers.
In Kacsmaryk’s 67-page decision, he ruled that the FDA “improperly” approved the abortion pill mifepristone more than two decades ago. Kacsmaryk wrote that the FDA overstepped its authority in approving the drug partially by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.”
FDA regulations state that pregnancy is a medical condition that can be serious and life threatening, but Kacsymaryk, who is not a scientist, argues it is a “natural process essential to perpetuating human life.” According to a report from the Centers for Disease Control and Prevention (CDC), the US had one of the worst rates of maternal mortality in the country’s history in 2021. The study found 32.9 maternal deaths per 100,000 live births, which is more than 10 times the estimated rate of other high income countries.
United States Health Secretary Xavier Becerra told CNN on Sunday that the ruling threatening the availability of the drug was “not America.” He did not rule out defying the judge’s order if necessary. “We want the courts to overturn this reckless decision,” Secretary Becerra said. “We want, yes, that women continue to have access to a drug that’s proven itself safe. Millions of women have used this drug around the world.”
[Related: What science tells us about abortion bans.]
Becerra added that Kacsmaryk’s order could have incredibly serious ramifications for the legality of any future or current FDA-approved drug.