Texas launched a lawsuit against the U.S. Food and Drug Administration last week over the agency’s approval of mifepristone, marking the state’s latest effort to crack down on access to abortion pills.
Joined by Florida, Texas Attorney General Ken Paxton filed the case on Dec. 9 in federal court in Wichita Falls. The two states argued in a 120-page complaint that the FDA did not properly evaluate mifepristone’s safety and effectiveness when approving the drug in 2000 and its subsequent generic versions. They also challenged the agency’s moves that expanded access to the pills, including the ability to dispense them by mail.
“The FDA’s regulation of mifepristone was political from the start,” the lawsuit said, pushing for the removal of the drug from the market.
In addition, the lawsuit argues that the Comstock Act of 1873 prohibits the mailing or delivery of anything intended for producing abortion, which could affect more than just mifepristone. The Biden administration interpreted this law, which has been unenforced for decades, to only cover unlawful abortions.
Mifepristone, when used with misoprostol, is the most common way Americans end their pregnancies. Studies have also shown the drug to be safe and effective.
The FDA said in a statement that it does not comment on litigation. Abortion access advocates have blasted the lawsuit.
“If they succeed in restricting access to mifepristone, abortion access will be devastated across the country, even in states where abortion remains legal,” Shellie Hayes-McMahon, executive director of Planned Parenthood Advocates of Texas, said in a Dec. 10 news release. “This lawsuit is not about safety or health care; it is about control. And nothing short of full control over our bodies will satisfy them.”
Mary Ziegler, a professor and abortion legal historian at the University of California Davis School of Law, said it was not surprising to see this lawsuit.
In recent years, there have been several efforts in the country to legally challenge access to mifepristone — the new frontier of the fight over abortion access after the fall of Roe v. Wade. They include a case filed in Amarillo, though the U.S Supreme Court rejected it last year and said the plaintiffs didn’t have standing to sue.
There has also been rising frustration among anti-abortion activists about the federal government’s approach, including the FDA’s decision in September to approve a generic version of mifepristone. In response, the agency told The New York Times that by law, these applications must be approved if “the generic drug is identical to the brand-name drug.”
“What we’re seeing is Texas is behaving more like Joe Biden as president than you would expect, right?” Ziegler said. “This is not a situation where Ken Paxton is sitting back and saying, ‘You know, the FDA is going to make these changes.’”
Texas’ latest mifepristone lawsuit comes days after its House Bill 7, which allows private citizens to sue anyone who manufactures or distributes abortion drugs to or from the state, went into effect.
Ziegler said these developments reflect the anti-abortion movement’s reliance on the courts to make gains, as there is less political appeal to take on the issue elsewhere in the country compared to Texas.
A federal policy change on mifepristone could also make blue states’ abortion shield laws that seek to protect providers from outside prosecution moot, the professor added. Texas went after an Ulster County clerk for refusing to file a civil judgment against a New York doctor accused of prescribing abortion pills to a Collin County woman, but a New York judge dismissed that challenge in October.
“A lot of it is about going to court because going to court seems a lot more promising right now than any of the alternatives,” Ziegler said.
Paxton’s office didn’t immediately respond to comment requests.
