Florida, Texas sue FDA over long-standing approval of abortion drug mifepristone

ORLANDO, Fla. - Two Republican-led states are challenging more than two decades of federal decisions that allowed mifepristone to be approved, regulated and shipped by mail. 

The lawsuit seeks to roll back FDA actions that expanded access to the drug, arguing they violate both federal law and state abortion restrictions.

What we know:

Florida and Texas filed a federal lawsuit Tuesday in Wichita Falls, Texas, seeking to invalidate FDA decisions dating back to 2000 that approved and later loosened restrictions on mifepristone, a medication used to end pregnancies. 

The 120-page complaint argues that the FDA’s actions were "arbitrary" and an "abuse of discretion" under the Administrative Procedure Act. It also cites an 1873 law, the Comstock Act, in asserting that abortion drugs cannot legally be mailed.

The lawsuit names the FDA, the U.S. Department of Health and Human Services and agency leaders as defendants and claims federal policies conflict with state abortion limits passed after the U.S. Supreme Court overturned Roe v. Wade in 2022.

What we don't know:

It remains unclear how quickly the federal court will take up the case or how it may interact with two other ongoing lawsuits involving mifepristone access. 

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The long-term effect on nationwide availability of the drug is uncertain, especially as state-level abortion bans continue to evolve. It is also not known what specific regulatory changes the Trump administration’s newly announced review of mifepristone may produce or whether they could influence the litigation.

The backstory:

The FDA first approved mifepristone in 2000 and has since updated its regulations, including expanding gestational limits from 49 to 70 days in 2016, allowing non-physicians to dispense the drug and lifting in-person dispensing requirements in 2021 and 2023. 

Those changes coincided with major political shifts and were implemented under Democratic administrations.

After Roe v. Wade was overturned in 2022, Florida, Texas and other Republican-led states enacted more restrictive abortion laws. Florida’s six-week abortion limit took effect in May 2024 and includes in-person dispensing requirements and a ban on telehealth abortions.

Big picture view:

Mifepristone is used in roughly two-thirds of U.S. abortions, according to reproductive-rights groups, making any ruling on its legality nationally significant. 

With multiple lawsuits targeting the drug and a pending regulatory review by the Trump administration, access to medication abortion has become one of the most contested issues in post-Roe America. 

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The outcome could reshape not only abortion access but also the FDA’s authority to regulate pharmaceuticals.