Florida and Texas re-file lawsuit challenging abortion pill

The States of Texas and Florida have filed a new lawsuit against the U.S. Food and Drug Administration (FDA), asserting that "the FDA’s approval and deregulation of abortion drugs have placed women and girls in harm’s way."

"The lawsuit, filed Tuesday in federal court in Wichita Falls, Texas, by Florida Attorney General James Uthmeier and Texas Attorney General Ken Paxton," CBS News reported, "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."

Key Claims:

Claims made by the two states in the latest lawsuit were similar to those previously made and detailed by Live Action News:

• The approval process was "political from the start."

• "States have the sovereign power to enact and enforce regulations on abortion."

• "The FDA’s actions seek to enable the violation of state laws restricting abortion."

• Telehealth and mail-order abortion was a "boon for sex traffickers" and mailing abortion pills to men has "facilitated the death[s] of multiple preborn children."

• States "have been forced to divert resources to address the explosion of abortion drugs mailed to their residents by abortionists operating under...'shield laws.'"

• "... The FDA’s actions have inflicted concrete economic injury on states as the payers and insurers of residents’ medical expenses."

• "Chemical abortions are often deleterious to mental health."

• The 2000 approval did not comply with the federal Comstock Act. 

Texas and Florida also claimed that "inadequate adverse event reporting" has led to the undercounting of "true rates of risks associated with chemical abortion drugs," meaning that the risks are "therefore... unknown."

Backstory:

The Alliance for Hippocratic Medicine (AHM) initially challenged the FDA's abortion pill approval as well as its expansions. However, in 2024, the U.S. Supreme Court ruled that the plaintiff doctors in AHM did not have standing to sue, and they eventually dropped their challenge.

Then, in January 2025, Judge Matthew Kacsmaryk ruled that the states of Missouri, Kansas, and Idaho could intervene in that case and file a complaint in Amarillo, Texas. A month later, in May, Trump’s Department of Justice (DOJ) called for dismissal of the lawsuit.

In August 2025, the states of Texas, and Florida first petitioned the court to intervene — and one month later (September 2025), the State of Louisiana along with Rosalie Markezich filed a motion to do the same. Markezich claimed in her complaint that her boyfriend ordered abortion pills from a California provider and coerced her into taking the pills. Her baby died.

But, later that same month, Judge Kacsmaryk denied the motions by Texas, Florida, and Louisiana and moved the venue to Missouri.

In October of 2025, Alliance Defending Freedom (ADF) refiled the lawsuit in State of Louisiana v. FDA (along with Rosalie Markezich) in the Western District of Louisiana, Lafayette Division.

This week (on December 9, 2025), a new lawsuit, State of Florida and the State of Texas v. FDA was filed in the Northern District of Texas, Wichita Falls Division.

The Newest Lawsuit:

Abortion Drugs Harm Women

In their latest lawsuit, the States of Florida and Texas claimed:

Abortion drugs harm women and girls. The FDA’s Patient Agreement warns women that a range of listed “symptoms” could “require emergency care.”

Mifepristone’s label states that roughly one in 25 women who take abortion drugs will end up in the emergency room. The FDA acknowledges that up to 7% of these women require a “surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding” and other “miscellaneous complications.

They also stated:

Studies estimate that as many as 20% of women who take mifepristone suffer a serious adverse event, and the FDA’s own label estimates that one in every 25 users will need to visit the emergency room.

The risks do not end with hospitalization. FDA data shows that, on average, abortion drugs claim the life of at least one woman each year in the United States.

These are tragic but predictable consequences of prioritizing politics over public health.

Deception and Lies

Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to present to emergency rooms and falsely claim that they are experiencing natural miscarriages. This deception virtually guarantees that complications have been misreported for many years, and quite possibly will never be accurately reported. The lawsuit also pointed to this:

Many abortion providers and facilitators shroud their operations in deception and encourage women to lie to emergency room staff by saying they are having a miscarriage if they suffer complications requiring urgent care. This advice places women in significant danger, as doctors who mistake botched abortions for a miscarriages may not provide the proper care. Allowing the drug to be self-administered has thus created a state of affairs where emergency room doctors often do not know that their patients are experiencing complications from abortion drugs.

Protecting Preborn Life

The lawsuit emphasized, "States have the sovereign power to enact and enforce regulations on abortion," adding:

State abortion laws serve the important state interests of “respect for and preservation of prenatal life at all stages of development; the protection of maternal health and safety; the elimination of particularly gruesome or barbaric medical procedures; the preservation of the integrity of the medical profession; the mitigation of fetal pain; and the prevention of discrimination on the basis of race, sex, or disability.”

"Mail-Order Abortion Economy"

"Telehealth abortion is illegal in Florida and Texas," the lawsuit stated, challenging recent expansions of the abortion pill by mail as "inflict[ing] economic injury" because of the "expense of investigating, prosecuting, and enforcing judgments for illegal mail-order abortions."

The states said abortion pill dispensing changes created "a mail-order abortion economy in all 50 states" which has forced the Plaintiffs "to divert resources to address the explosion of abortion drugs mailed to their residents by abortionists operating under... their States’ 'shield laws.'”

The lawsuit also called out the recent FDA approval of a second generic drug maker, Evita Solutions, LLC, claiming the "second generic version will further increase competition and lower the cost of chemical abortion when it becomes available in January 2026."

Violating Federal Law

The abortion pill (mifepristone 200 mg) was approved in 2000 by President Bill Clinton's administration. It was the Obama administration’s FDA in 2016 that weakened the FDA's REMS safety requirements, expanding use of the drug to 10 weeks gestation and removing the requirement for the manufacturer to report the drug’s non-fatal adverse events (complications), among other changes. The lawsuit refers to these as "Major Changes"(emphasis added):

These 2016 Major Changes were made without a single study evaluating the safety and effectiveness of mifepristone and misoprostol under the new conditions and without the safety assessment for pediatric populations required by law...

... After Biden’s inauguration as President, the FDA gutted what was left of the mifepristone REMS from 2021 to 2023, authorizing abortion drugs to be sent by mail and dispensed at pharmacies (the “2021/2023 Dispensing Changes”).

The lawsuit also acknowledges that the federal Comstock Act "prohibits the mailing or delivery" of abortion drugs:

In addition to being untethered to any medical research evaluating the safety and effectiveness of mail-order abortion drugs, these changes openly defy federal law criminalizing the use of the mails to convey “[e]very article or thing designed, adapted, or intended for producing abortion.” 18 U.S.C. § 1461...§ 1462...

"These actions... were arbitrary, capricious, an abuse of discretion, not in accordance with law, and therefore invalid under the Administrative Procedure Act," the legal document claimed. "To protect their residents and vindicate their economic and sovereign interests, the States of Florida and Texas... petition this Court to declare the Challenged Actions unlawful and set them aside," they wrote.

Politicized Process

Texas and Florida argued that the abortion pill's approval process was "politicized" from the start, citing a 1994 memo composed by HHS Chief of Staff Kevin Thurm, underscoring the drug's "great significance" to "pro-choice and women’s groups" and cautioning that a failure to introduce it would "weaken our political base."

The legal challenge also cited Ruth B. Merkatz, former director of HHS’s Office of Women’s Health from 1994 to 1996:

"It was really a revolutionary decade in the ‘90s. We knew RU-486 was going to be very important especially in states where surgical abortions are not permitted. And if they overturn Roe v. Wade, it’s going to be really important."

The states further contend that subsequent expansions were politically motivated, pointing out that these changes were implemented without studies on safety and effectiveness. They cited then-Vice President Joe Biden, who promised to "vastly expand" abortion access and declared that there "should be no restrictions at all on the ability to get those drugs."

Finally, the complaint notes recent commitments from the Biden administration (which described the overturning of Roe as “an extreme decision”) and HHS Secretary Becerra to "use every lever" to "defend" and "strengthen" the so-called right to abortion.

As President, Biden described the overturning of Roe as “an extreme decision" and “committed to doing everything in his power” to “protect access” to abortion.

Summing Up:

"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.