A federal judge in Texas on Friday suspended the Food and Drug Administration’s approval of mifepristone, a drug commonly used in medication abortions, in a closely watched case with potentially explosive implications for the availability of abortion nationwide, regardless of state laws and politics.
Judge Matthew Kacsmaryk’s order suspending the FDA’s approval of mifepristone takes effect in seven days—giving the federal government time to ask the Fifth Circuit to block it.
On the same day Kacsmaryk issued his ruling, a federal judge in Washington state issued a dueling order in a case brought by Democratic state attorneys general. That order temporarily forbids the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.” It’s not yet clear what the two conflicting orders mean for the future of the pill.
Kacsmaryk didn’t just rule that the FDA’s approval isn’t valid—he also put his stamp of approval on a controversial legal theory that a 19th century anti-obscenity law, known as the Comstock Act, makes mailing mifepristone illegal, according to reproductive law scholar Mary Ziegler.
“It is indisputable that chemical abortion drugs are both ‘drug[s]’ and are ‘for producing abortion,'” Kacsmaryk wrote in his order. “Therefore, federal criminal law declares they are ‘nonmailable.'”
In response to Kacsmaryk’s ruling, Attorney General Merrick Garland released a statement saying the Justice Department “strongly disagrees” with the Texas judge and will be appealing the decision. “Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” Garland wrote.
Mifepristone is used in approximately 50 percent of abortions in the United States and has been in use for over two decades. As I reported last month:
The medication at issue in the lawsuit, sold under the brand name Mifeprex, has been approved by the FDA for over two decades as part of a two-drug regimen to end pregnancies within the first 10 weeks. Mifepristone blocks the hormone progesterone, causing pregnant peoples’ uterine lining and implanted embryo to begin breaking down. The second drug in the regimen, the anti-ulcer drug misoprostol, is taken 24 to 48 hours later to soften the cervix and cause contractions. The drugs can be taken safely at home and are successful in 99.6 percent of cases, according to the National Academies of Sciences, Engineering, and Medicine.
Yet the lawsuit was brought by anti-abortion groups who strategically filed in Kacsmaryk’s district:
The lawsuit Kacsmaryk is considering was brought by the Alliance Defending Freedom, the conservative Christian legal behemoth that drafted the Mississippi abortion ban at the heart of the case that overturned Roe v. Wade. The complaint, filed on behalf of four doctors and a handful of anti-abortion medical organizations, claimed that the FDA had overlooked potentially harmful side effects when it green-lit mifepristone 23 years ago. (According to the FDA, the original approval of mifepristone was based on “a thorough and comprehensive review of the scientific evidence” that found the drug was “safe and effective” when used as directed, and follow-up data in the ensuing years has turned up no new safety concerns.) In addition, the lawsuit argues the FDA’s approval “exceeded its regulatory authority” in part because pregnancy is not an “illness,” and also because an 1873 federal law made it a crime to distribute “obscene, lewd or lascivious” material through the mail, including “any article or thing” intended to be used for abortion.
The arguments in the case are seen by legal experts as a stretch, and that’s being generous. But in a strategic move, Alliance Defending Freedom filed the complaint in Amarillo, Texas—virtually guaranteeing that it would be heard by Judge Kacsmaryk. A former staff attorney for a religious-right legal firm, the controversial judge was already known for making anti-abortion and anti-LGBTQ statements at the time he was nominated by Trump and confirmed by a Republican Senate. Since then, conservative legal activists have been lining up to send him their cases—and he’s delivered, forcing the Biden administration to reinstate Trump’s “Remain in Mexico” border policy. In two cases late last year, Kacsmaryk ruled that anti-LGBTQ discrimination was permissible in heath care and struck down a rule that had promised confidentiality to teens who sought birth control from federally funded family planning programs. Both lawsuits happen to have been filed by former Texas solicitor general Jonathan Mitchell, the architect of the state’s 6-week abortion ban and its “bounty hunter” enforcement mechanism.
You can read Kacsmaryk’s ruling here:
This post has been updated.