Florida and Texas agree to put abortion pill lawsuit against FDA and others on hold

The States of Florida and Texas have agreed to a 'stay' in a joint lawsuit filed against the U.S. Food and Drug Administration (FDA) and abortion pill manufacturers Danco and GenBioPro (GBP), while the FDA conducts a safety review of mifepristone (200mg)/Mifeprex.

The Response to the Motion to Stay on April 24, 2026, concluded:

In light of the FDA’s substantive reevaluation of all the Challenged Actions, the States agree that this case should be stayed for a reasonable amount of time. If a stay is not granted, the Court should deny the motions to dismiss.

The States of Florida and Texas are among six states which have filed lawsuits against the FDA —but they are the first to agree to put their lawsuits temporarily on hold.

Key Takeaways:

• The States of Florida and Texas have agreed to put their joint lawsuit against the FDA and abortion pill manufacturers on hold while the FDA conducts a safety review of mifepristone (200mg).

• The States are two of six states that filed lawsuits against the FDA —but they are the first to agree to put their lawsuits temporarily on hold.

• The States attempted to place conditions (including a nine-month review limit) on agreeing to the stay, but the DOJ/FDA/HHS did not agree to placing any conditions on the stay.

• The FDA's review is reportedly “evaluating issues . . . ranging from eliminating the REMS entirely to withdrawing the approval of mifepristone for termination of early pregnancy, as well as actions in between.”

• Daniel J. Schmid of Liberty Counsel stated that Florida and Texas likely knew the stay would be granted regardless, and made "an eminently practical decision."

The Details:

Florida and Texas noted that because the "FDA is substantively reconsidering each Challenged Action" in their joint lawsuit, the "States agree that the circumstances favor staying these proceedings for a limited period sufficient for the timely completion of the review."

It is important to remember that in State of Louisiana v. Food and Drug Administration (FDA), the FDA admitted that "if the Secretary of Health and Human Services finds that a drug presents "an imminent hazard to the public health,” the Secretary may suspend the approval of the application "immediately...."

Florida and Texas' Response to the Motion to Stay pointed out how the abortion pill (mifepristone 200 mg) not only kills preborn children, but "endanger[s] the life of the mother" with real-world adverse events such as "hemorrhaging, sepsis, and other complications" as well as the risk of death.

The States added that because of the FDA's "approval and regressive deregulation of abortion drugs," it "takes little more than a few clicks of the mouse" to get the drugs delivered by mail. They concluded that this was the result of "politics, plain and simple."

E-mail exchanges

Florida's motion included the declaration of Samuel F. Elliott, deputy solicitor general in the Office of the Florida Attorney General, who detailed an e-mail he received from Noah T. Katzen, an attorney at the U.S. Department of Justice representing the FDA, FDA Commissioner Martin A. Makary, HHS, and Secretary Robert F. Kennedy, and the director of the Center for Drug Evaluation and Research in the case.

The declaration detailed a back and forth exchange, in which Elliott informed Katzen that "the States’ position on the motion for stay 'would likely [depend] on the scope of the FDA’s review of the mifepristone REMS.'"

On January 30, 2026, Elliott stated:

I explained that “our lawsuit challenges the FDA’s regulation of mifepristone going back to the drug’s initial approval in 2000. If the FDA’s review is reevaluating each of the actions challenged in our lawsuit, the States may be willing to consent to the stay. If the FDA’s review is limited to reevaluating only a subset of those actions, it would make little sense for Florida and Texas to consent to the stay.”

On February 6, 2026: Katzen claimed that the review would be more extensive than this:

“The agency’s review of the mifepristone REMS includes reviewing and evaluating issues raised in a number of citizen petitions seeking different actions, ranging from eliminating the REMS entirely to withdrawing the approval of mifepristone for termination of early pregnancy, as well as actions in between, such as reinstating the conditions of use in place before 2016 or reinstating the in-person dispensing requirement.

Of course, we do not know what the outcome of that review will be. But whatever the outcome, following its review, FDA will take any steps it determines are appropriate, in accordance with its statutory and regulatory authorities.”

On February 12, Elliott told Katzen the team would discuss and respond soon.

Then, on March 11, Elliott told Katzen the States were “willing to join the motion under two conditions,” including that a "maximum duration" for the FDA's review must be set, "not to exceed nine months unless the parties agree to an extension," and that the motion specifies that "the States' consent... is premised on..." the FDA's claim that it is examining...

“actions ranging from eliminating the REMS entirely to withdrawing the approval of mifepristone for termination of early pregnancy, as well as actions in between, such as reinstating the conditions of use in place before 2016 or reinstating the in-person dispensing requirement.”

But on March 13, Katzen said the federal government would "not agree to attach conditions." He added that if the States did not agree to the stay without conditions, the government would "file our motion to stay or, alternatively, dismiss today.”

Reportedly, "The States did not respond prior to the filing of the Government Defendants’ Motion to Stay, or Alternatively, to Dismiss later that day."

Florida pointed out:

The FDA’s current review... is “evaluating issues . . . ranging from eliminating the REMS entirely to withdrawing the approval of mifepristone for termination of early pregnancy, as well as actions in between.”

In context, this representation clearly reveals the FDA’s “intention to put the [Challenged Actions] back on the chopping block and rethink things.”

Speculation on Florida's Reasoning

Live Action News reached out to the Florida Solicitor General's Office for comment but as of the writing of this article has not received a reply.

Daniel J. Schmid, Esq., Associate Vice President of Legal Affairs of Liberty Counsel, located in Florida, suggested to Live Action News that the State of Florida may have understood that "the matter was going to be stayed one way or the other," and that it was "an eminently practical decision."

Schmid continued (emphasis added):

"I certainly think there is evidence that the entire [abortion pill] approval [from 2000] should be withdrawn. But, at minimum, I think the FDA is likely to revisit the 2021 Nonenforcement Decision, the 2016 Amendments to the restrictions on dispensing mifepristone, and certainly the 2023 REMS (which essentially and intentionally had no evidentiary support).

Again, Judge Joseph in Louisiana (and the Fifth Circuit before him in its prior Alliance for Hippocratic Medicine decision) have already essentially held... that the FDA did not comply with the law in these actions....

The statement of the federal courts and the current FDA are pretty damning indictments of those decisions and should produce a revision to the most recent decisions, if nothing else.

The Backstory:

Lawsuit Background

2022: Alliance for Hippocratic Medicine (AHM) challenged the FDA's abortion pill approval and erosions of REMS safety regulations.

2024: U.S. Supreme Court ruled that plaintiff doctors in AHM did not have standing to sue, and they eventually dropped their challenge. Since that ruling multiple lawsuits, involving six states, have been filed.

August 2025: State of Florida v. FDA (which included the State of Texas) first petitioned the court to intervene in the lawsuit was refiled was  filed in the Northern District of Texas, Wichita Falls Division in December.

February 2026: FDA's website claimed it is "conducting a safety study of mifepristone" and it would be "done sooner than" the typical year-or-more timeframe.

March 2026: motion was filed by the DOJ to stay or dismiss in the Florida/Texas lawsuit.

April 1, 2026: The States file an extension.

April 12, 2026: Danco and GenBioPro file separate motions to dismiss the Florida/Texas lawsuit.

April 24, 2026: Florida files a response motion to stay or dismiss the the Florida/Texas lawsuit.

Lawsuit Claims

Claims made by the two states in refiled court documents were similar to those previously made and detailed by Live Action News:

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

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

• "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.'"

• "... 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. 

1st Trimester Abortion | The Abortion Pill | What Is Abortion?

The Bottom Line:

Schmid stressed to Live Action News that "the sole purpose of this drug is to slaughter innocent children," and therefore:

"It does not matter what procedures are followed to purportedly legitimize its safety and efficacy, it is neither safe nor efficacious for the millions of children it has slaughtered over the years... [G]iven the significant evidence of substantial harm to the women who take this drug, it adds salt to the already fatal wounds it is delivering to unborn children."

He summed up, "Put simply, it ought to be ripped from the market and its tyrannical regime of death relegated to the dustbin of history."