A Texas judge ruled late Friday to block the Food and Drug Administration’s approval of a common and effective abortion pill. Under this order, which is set to take effect in seven days, the drug mifepristone—which is safer than Viagra and 18 times safer than childbirth—may be yanked from the market regardless of whether a state protects abortion rights.
Judge Matthew Kacsmaryk’s ruling suspending FDA’s 2000 approval of mifepristone came in response to a lawsuit filed late last year by a group of anti-abortion doctors and organizations. They accused the FDA of abusing its authority when it approved mifepristone more than two decades ago.
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Kacsmaryk, who was appointed by former President Donald Trump, gave the Biden administration one week to appeal his ruling before it takes effect. The ruling could be appealed to the famously conservative U.S. Court of Appeals for the Fifth Circuit in Louisiana. It could then land in front of the Supreme Court and its 6-3 conservative majority, making it the first abortion-related case to be heard by the Supreme Court since the justices struck down Roe v. Wade last year.
The case is perhaps especially likely to end up at the Supreme Court because a Washington state judge ruled on Friday that the FDA should not change its approach to mifepristone. This conflicting ruling, written by a judge appointed by former President Barack Obama, found that a nationwide injunction would be “inappropriate.”
After a four-hour marathon hearing in Amarillo, Texas in the case, Kacsmaryk previously pressed lawyers from the Justice Department and from the Alliance Defending Freedom, which is representing the anti-abortion groups. He asked whether the “courts have intervened in such a way” and intervened so many years after the FDA had approved a drug, the Washington Post reported.
An Alliance Defending Freedom lawyer admitted that no, this has never happened before. Experts have also agreed that Kacmaryk’s ruling is unprecedented. It could also open up challenges to other forms of medication that political and advocacy groups object to—such as hormone treatment for transgender people.
As of 2020, medication abortions, which typically use mifepristone, accounted for more than half of all abortions in the United States. Pulling mifepristone from the market will not immediately vaporize access to medication abortion, although it will complicate it.
At least one senator, Democratic Oregon Sen. Ron Wyden, has already urged the FDA and the Biden administration to ignore Kacsmaryk. Three major abortion providers—Whole Woman’s Health, Trust Women, and the telehealth organization Hey Jane—have said that they will continue dispensing mifepristone until the FDA issues a directive telling them to stop. Washington state has also started to stockpile mifepristone in anticipation of Kacsmaryk’s ruling.
Several abortion providers have announced in recent weeks that if the FDA eliminated legal access to mifepristone, they would pivot to inducing medication abortions using another pill, misoprostol. Although American abortion providers typically use mifepristone and misoprostol in medication abortions, it is possible—though slightly less effective—to do it with misoprostol alone. The World Health Organization already has a recommended protocol for doing so.
However, the underground market for mifepristone is already thriving. Covert channels shipped at least 20,000 packets of abortion pills out to people in the United States between the June overturning of Roe and December. Medical experts widely consider it safe to self-manage an abortion, early in a pregnancy. However, there is a legal risk. Although just a few states explicitly ban self-managed abortion, advocates have long warned that an anti-abortion prosecutor who wants to charge someone will find a statute with which to do that. Between 2000 and 2020, at least 61 people were criminalized for allegedly being involved in a self-managed abortion, according to a report last year from the advocacy group If/When/How.
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