Texas and Florida add persuasive arguments to abortion pill lawsuit

Florida and Texas have moved to intervene in an ongoing lawsuit challenging the expansion of the abortion pill, mifepristone (200mg), alleging that the drug's approval was 'political,' that states have the right to regulate abortion, and that federal law prohibits mailing abortion drugs.

Key Takeaways:

The states of Florida and Texas allege in the lawsuit:

• "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 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."

The Backstory:

The lawsuit, now named State of Missouri v. FDA, was originally filed in Amarillo, Texas, by plaintiff doctors in the Alliance for Hippocratic Medicine (AHM), but in 2024, the U.S. Supreme Court ruled that those plaintiff doctors did not have standing to sue.

In January 2025, U.S. District Judge Matthew Kacsmaryk ruled that the states of Missouri, Kansas, and Idaho could intervene and file a complaint in the lawsuit, but in May, Trump’s Department of Justice (DOJ) called for dismissal of lawsuit.

In August, Texas and Florida petitioned the court to intervene.

The Arguments:

'Politically Motivated'

In 2000, the FDA approved the abortion pill for use up to seven (7) weeks of pregnancy in a regimen with the drug misoprostol. Live Action News has documented the secrecy and conflicts of interest surrounding the drug.

The Clinton Years

Florida and Texas stated:

The FDA’s regulation of mifepristone was political from the start...Bill Clinton promised to bring mifepristone to market... On his second day in office, President Clinton directed the Department of Health and Human Services to 'promote the testing, licensing, and manufacturing in the United States of RU-486....

Correspondence during this time reveals that HSS [sic; HHS] viewed the approval of mifepristone as a 'political issue.' For instance, a memorandum composed by HHS Chief of Staff Kevin Thurm in 1994 reminded the White House that mifepristone was of 'great significance to the pro-choice and women’s groups' who expected the Clinton administration to 'do everything possible to get RU 486 introduced in this country.' Thurm warned that failing to deliver on this 'promise' would 'weaken[] our political base and may subject the President to criticism that he is not sticking to his original position.'

The complaint cited Ruth B. Merkatz, 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.

In 1992, Ron Weddington — a co-counsel for the plaintiff in Roe v. Wade and the ex-husband of Roe attorney Sarah Weddington — wrote an open letter to the Clinton administration recommending that he “eliminate” certain segments of society via abortions, the RU-486 abortion pill, and other means.

Yet, the complaint notes:

President Clinton’s advisors cautioned that approving mifepristone before the 1996 presidential election would 'provide ample opportunity for Republicans and others opposed to the Administration to focus attention on this decision and on its aftermath.'

In 1993, President Clinton signed an executive order directing the FDA to expedite marketing of RU-486. In 1994, his administration pressured the French pharmaceutical manufacturer Roussel-Uclaf to assign the U.S. rights of marketing and distribution to the Population Council, which brought the drug into the U.S. and set up  Danco Laboratories, LLC, as a sub-licensee.

The Obama Years

In the complaint, Texas and Florida suggested that President Obama vowed to "protect[] the gains of the past," motivating his FDA to remove the in-person requirements from the REMS safety regulations on the abortion pill.

Texas and Florida pointed out:

These 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.

"... Vice President Biden promised to 'vastly expand' access to abortion 'across the spectrum.' With respect to chemical abortion, Biden said: 'there should be no restrictions at all on the ability to get those drugs," the lawsuit claimed.

The Biden Years

When Biden became 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," noted the complaint.

Biden also "tasked HHS...to explore steps to 'ensure access to safe and legal abortion.' Officials were to 'use every lever at their disposal to ensure . . . access' for 'every woman . . . across the country,'” the document claimed. Biden was “committed to doing everything in his power” to “protect access” to abortion.

According to the complaint:

HHS would be a key part of this 'whole-of-government approach.' HHS was 'to look for ways to make sure we are providing access to healthcare to women' and the FDA would make a decision about lifting the REMS on mifepristone.

The complaint also cited a statement made by HHS Secretary Becerra during the Biden years, who promised, "We will double down and use every lever we have to protect access to abortion care," later stating the administration would “take steps to increase access to medication abortion” and “leave no stone unturned."

Failure to Study Abortion Pill's Effects on Minors

"The Pediatric Research Equity Act (PREA) was enacted in 2003 to require studies on the safety and effectiveness of drugs intended for pediatric populations, unless certain exceptions apply," Texas and Florida wrote, adding:

In general, PREA requires a drug application or supplement to an application to include a safety and effectiveness assessment for the claimed indications in all relevant pediatric subpopulations... This assessment must also support dosing and administration for each pediatric subpopulation for which the drug is safe and effective.

But this didn't happen.

The states wrote that "[s]ince the 2000 Approval, the FDA has continued to allow pregnant girls of any age to take chemical abortion drugs — despite never requiring a study... The 2016 Major Changes continued to allow pregnant girls of any age to use mifepristone...."

In addition, they claimed:

The FDA did not require Danco to submit an assessment on the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations, nor did the FDA require Danco to submit an assessment that supported the dosing and administration for each pediatric subpopulation for which the drug is safe and effective.

Studies Did Not Cover FDA Changes

Texas and Florida claimed 2016 changes by the Obama FDA were not supported by studies, noting that increasing the allowed gestational age for the abortion pill from 7 to 10 weeks also increased "rates of abortion failures, surgical interventions, and complications."

The complaint noted (emphases added):

The FDA relied on three studies... but all of them included in-person, post-abortion follow-up visits — one of the safeguards the agency removed despite previously calling it 'very important.'

Without an initial in-person visit, women may underestimate gestational age and take the drugs past the approved 10-week limit, or do so intentionally. Women beyond ten weeks have higher 'chances of complications due to the increased amount of tissue, leading to hemorrhage, infection[,] and/or the need for surgeries or other emergency care.'

2016 changes also removed requirements for prescribers to report adverse events other than death. The lawsuit cited a recent EPPC analysis suggesting significant numbers of women present to emergency rooms after self-managed abortions.

"Abortion providers who prescribe or dispense chemical abortion drugs... are not providing women with an adequate, accurate assessment of the known risks and effects associated with chemical abortion," the complaint added. "Therefore, women and girls are unable to give informed consent for the drugs they are receiving, and thus they are not consenting at all... resulting in physical and mental injuries."

Lies, Deception, Drug's Stability

The states also pointed out a significant deception that Live Action News has decried for a number of years (emphases added):

FDA did not address the health risks associated with misdiagnosing an abortion-drug complication, or the common practice among abortion-drug providers of encouraging women to tell emergency staff that they are having a miscarriage when they present with complications.

Many abortion providers... 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.

In addition to this, there are concerns about mail transit resulting in compromised drugs/efficacy:

FDA’s own label for mifepristone requires a storage temperature of '25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)... These conditions cannot be guaranteed during standard shipping transit, particularly in summer or winter weather conditions. The FDA’s decision to allow mail-order abortion drugs neither acknowledged nor addressed this known issue.

The Bottom Line:

The federal Comstock Act (U.S.C. §§ 1461–62) prohibits the shipment or mailing of abortion drugs. Two U.S. Supreme Court Justices previously hinted that Comstock could be in play, during oral arguments in the AHM v. FDA lawsuit.

Today, abortion providers in multiple states are admittedly shipping abortion pills “unlawfully” into states that prohibit them or restrict telehealth dispensing. Florida and Texas stated that these providers "openly defy federal law."

"Because a federal agency cannot permit what federal law expressly prohibits," they wrote, "the FDA lacked legal authority when issuing the 2021/2023 Dispensing Changes."

As this complaint points out, the approval and distribution of the abortion pill — for 25 years now — has been politically motivated, with women's health and safety seemingly the least of Big Abortion's concerns.