Texas, Florida Sue To Invalidate the FDA’s Approval of Abortion Drug

The lawsuit says that the approval of the drug was ‘arbitrary’ and ‘capricious.’

Natalie Behring/Getty Images
A packet of mifepristone is seen at the Wellspring Center at Casper, Wyoming, on March 10, 2025. Natalie Behring/Getty Images

Two conservative states are challenging the federal government’s approval of the medical abortion drug mifepristone in an effort to have that approval invalidated.

Texas and Florida filed a federal lawsuit this week, challenging the Food and Drug Administration’s approval of mifepristone, which occurred in 2000.  It also challenges the FDA’s subsequent decision to relax restrictions on the pill, such as letting nonphysicians dispense the drug. Mifepristone is used in roughly two-thirds of abortions in America.

The lawsuit argues that the decision to approve the drug was “arbitrary, capricious” and an “abuse of discretion.”

“The United States Food and Drug Administration is responsible for ‘protect(ing) the public health by ensuring that … drugs are safe and effective.’ Yet the FDA’s approval and deregulation of abortion drugs have placed women and girls in harm’s way,” the lawsuit alleges.

The complaint argues that the ability to ship abortion pills through the mail interferes with states’ ability to enforce their abortion restrictions and violates the 1873 Comstock Act, which prohibits the shipment of abortion drugs but has not been enforced for decades.

Several federal lawsuits brought by individuals have also argued that the shipment of abortion pills violates the Comstock Act. The lawsuits appear to be part of a strategy to get the Supreme Court to consider the legality of the interstate shipment of abortion medication.

In 2024, the Supreme Court rejected a challenge to the FDA’s decision to loosen restrictions on mifepristone, finding that the plaintiffs — a group of doctors and organizations opposed to abortion — had not shown that they had been harmed by the moves to increase access to the drug.

Justice Brett Kavanaugh said that the challengers had “sincere legal, moral, ideological, and policy objections” to abortion, but that, with the lack of evidence of being harmed by the policies, they did not have standing to bring the case in federal court.

There are two other federal lawsuits challenging the approval of mifepristone, and the Trump administration announced earlier this year that it is reviewing the FDA’s approval of the pill. It remains to be seen whether the administration will announce any regulatory changes regarding mifepristone and how those could impact the litigation.

The lawsuit from Texas and Florida has received criticism from the ACLU, which said the multiple lawsuits challenging mifepristone have “nothing to do with the safety of this medication and everything to do with making it harder for people to get an abortion.”

Conservative states have been trying to stop the shipment of abortion pills through other means. Texas and Louisiana have sought civil and criminal sanctions against a New York-based doctor accused of sending abortion pills to those states.


Meanwhile, Texas enacted a law that lets private citizens sue doctors for a minimum penalty of $100,000 for shipping abortion pills to the state.


The New York Sun

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