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Florida, Texas seek to overturn FDA's Mifepristone regulations, claiming mail access undermines state abortion laws

Florida and Texas have filed a lawsuit challenging more than two decades of federal government decisions that cleared the way for the use of abortion drugs — and said the availability of the drugs through the mail has interfered with state laws designed to prevent abortions.

The lawsuit, filed Tuesday in federal court in Wichita Falls, Texas, by Florida Attorney General James Uthmeier and Texas Attorney General Ken Paxton alleges that decisions by the U.S. Food and Drug Administration dating back to 2000 were "arbitrary, capricious" and an "abuse of discretion" and should be rejected.

"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 120-page lawsuit said, partially quoting from a federal law.

The lawsuit focuses on mifepristone, a drug that stops pregnancies. Another drug, misoprostol, is used to induce contractions and cause women's bodies to expel tissue.

ACLU lambasts the lawsuit, saying it has nothing to do with the medication's safety

The American Civil Liberties Union blasted the lawsuit, which it said is one of three cases across the country targeting Mifepristone. It said mifepristone is used in two-thirds of U.S. abortions.

"These lawsuits have nothing to do with the safety of this medication and everything to do with making it harder for people to get an abortion," Julia Kaye, senior staff attorney with the ACLU's Reproductive Freedom Project, said in a prepared statement. "Politicians in Texas and Florida are asking for a nationwide ban on a safe and effective medication that millions of Americans have used since the FDA first approved it 25 years ago. Anyone who believes that our access to essential medicines should be based on science, not political ideology, should be disgusted by these legal attacks."

The lawsuit challenges an initial FDA decision in 2000 to allow use of mifepristone and a series of subsequent decisions over the years that loosened restrictions. As an example, it said 2016 changes extended a maximum gestational period for using the drugs from 49 days to 70 days and allowed non-physicians to dispense the drugs.

Also, for example, it said the federal government in 2021 and 2023 did away with an in-person dispensing requirement and allowed the drugs to be shipped.

The lawsuit alleges the FDA's actions violated a federal law known as the Administrative Procedure Act, which directs the process for agencies to set rules. Also, it contends that an 1873 law known as the Comstock Act prevents sending abortion drugs through the mail.

The lawsuit also argues that the FDA decisions were politically motivated, as they were made under Democratic Presidents Bill Clinton, Barack Obama and Joe Biden.

The debate surrounding abortion medication has ramped up since the overturning of Roe. v. Wade

Debates about Mifepristone have ramped up after the U.S. Supreme Court in 2022 overturned the landmark Roe v. Wade abortion-rights decision. Republican-led states such as Florida and Texas then passed abortion restrictions.

A Florida law, which took effect in May 2024, prevents abortions after six weeks of pregnancy, with limited exceptions. The law also barred physicians from using telehealth to perform abortions and required in-person dispensing of abortion drugs.

The lawsuit alleges that the FDA's actions interfere with the ability of Florida and Texas to carry out their abortion restrictions. In addition to the FDA, the lawsuit names as defendants the U.S. Department of Health and Human Services and leaders of the agencies.

"Absent the relief sought in this lawsuit, defendants' actions will continue to encourage the violation of plaintiffs' laws and will harm plaintiffs' sovereign interests in the enforcement and enactment of their laws," the lawsuit said.

The ACLU said in a news release on its website that the Florida and Texas lawsuit "comes as the Trump administration appears to be gearing up to make it even harder for people to access the medication nationwide." The ACLU said the Trump administration announced this year that it is conducting a new review of mifepristone regulations.

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