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Missouri, Kansas, and Idaho have filed a lawsuit in federal court that renews a legal challenge against the U.S. Food and Drug Administration (FDA) over relaxing safety regulations and illegally allowing widespread access to the dangerous abortion pill Mifepristone. In June 2024, the U.S. Supreme Court dismissed a case from a group of pro-life doctors against the FDA’s abortion pill deregulation after the High Court determined the doctors did not have legal standing to sue. The new amended lawsuit, which could end up back at the Supreme Court in the future, asserts that the three states have legal standing because the relaxed restrictions undermine state pro-life laws protecting women, girls, and unborn children by putting lives and health at risk.

The lawsuit contends that the FDA “has the statutory responsibility to protect the health, safety, and welfare of all Americans by putting commonsense safeguards on high-risk drugs.” The states note that the FDA’s own warning label for abortion drugs say about one in 25 women taking the drugs “will visit the emergency room. The states allege that the FDA has “disregarded” health and safety by removing Mifepristone’s safety standards which has created conditions where women and girls can face severe and life-threatening complications due to easy access to the drugs through the mail and little to no medical oversight while taking them – conditions that bypass state pro-life protections and send women and girls to emergency rooms.

From 2016 to 2021, the FDA deregulated Mifepristone so it could be used through the 10th week of pregnancy, rather than only through the 7th week; allowed healthcare providers who are not physicians to prescribe the drugs; relaxed adverse reporting requirements; and allowed the drug to be prescribed online through telehealth appointments and sent through the mail defying the federal Comstock Act that prohibits sending abortion through the mail. The FDA made these changes despite the drug’s questionable safety record.

The states allege these actions not only violate the safety requirements of the Pediatric Research and Equity Act and the Federal Food, Drug, and Cosmetic Act due to the potential harms for pregnant women and girls, as well as the Comstock Act, they also disregard state abortion laws and “enable and encourage” people to do what state law expressly prohibits.

According to the three states, the FDA lacked legal authority to make these decisions and acted “arbitrarily and capriciously,” committed an “an abuse of discretion,” and acted “otherwise not in accordance with law.”

“[The] FDA permitted and sometimes even encouraged these illegal activities. But a federal agency cannot authorize unlawful actions,” wrote Missouri, Kansas, and Idaho. “In rolling back safeguard after safeguard, the FDA has turned a blind eye to the known harms of abortion drugs to the detriment of women and girls.”

The states are asking U.S. District Judge Matthew Kacsmaryk, who presided over the original abortion pill case, to impose a preliminary injunction that reinstates Mifepristone’s regulations that were in place prior to 2016. The lawsuit asks the judge to:

  • restore follow up visits with a physician on Days 3 and 14 after taking abortion drugs.
  • restore the maximum gestational age to seven weeks from 10 weeks.
  • restore the requirement that prescribers be physicians.
  • restore the requirement that physicians report all serious and non-fatal adverse events to the FDA.
  • restore the in-person dispensing requirement.

The lawsuit also gives Judge Kacsmaryk the option for a permanent injunction to render all of the FDA’s deregulation actions for Mifepristone as unlawful.

The three states noted in the lawsuit, “The FDA’s actions thus ‘intrude on state governmental functions’ and hobble States’ efforts to protect health and safety.”

In April 2023, Judge Kacsmaryk found that the FDA shouldn’t have approved Mifepristone for public use in 2000 and voided its approval. He noted the agency approved the abortion pill under political pressure, its safety studies were improperly conducted, and that the FDA’s regulatory decisions allowing them to be prescribed via telemedicine, sent by mail, and dispensed at retail pharmacies were unlawful. While the Fifth Circuit Court of Appeals largely upheld his ruling, the Supreme Court vacated the injunction allowing all of the FDA’s deregulation actions to stay in effect.

Mifepristone is part of a two-drug regimen that starves an unborn baby to death, while the second drug, Misoprostol, expels the baby from the womb. Mifepristone is manufactured under the label Mifeprex and comes with a “black box warning,” which is the FDA’s strongest warning for drugs with major risks. Before the FDA removed the reporting requirements for adverse events, 26 deaths and 4,207 adverse events associated with Mifepristone had been reported.

Mifeprex’s medication guide advises abortive mothers to expect cramping, vaginal bleeding, and that they may potentially see blood clots and tissue. The guide even states that 2.9 to 4.6 percent of women who take the drug will end up in the emergency room. With data suggesting the abortion pill accounted for 642,700 in 2023 – 63 percent of all abortions – the drugs could potentially cause up to tens of thousands of women going to the ER every year. In addition, the guide also acknowledges up to seven percent of women will need surgery “to stop bleeding” after taking Mifepristone.

Liberty Counsel Founder and Chairman Mat Staver said, “We commend Missouri, Kansas, and Idaho for continuing to challenge the FDA actions regarding the harmful abortion pill. This is another great example of perseverance in fighting the good fight. The FDA needs to be held accountable for its unlawful actions. The FDA should no longer be allowed to circumvent safety laws to allow a eugenic drug to destroy innocent children and harm women. Abortion drugs have never been safe and harm women and kill children.”

Author: Liberty Counsel

1 COMMENT

  1. Because Trump is so flummoxed on the abortion issue right now all we know this election is that for the Democrat Party abortion is the third rail of its politics, infusing every policy proposal. The Democrat Party is indeed the party of abortion and other evils. It would be glorious to have them repudiated this election on any number of scores and a Trump victory would largely be in line with that but we do not know if it would not be Pyrrhic in some areas, retarding rather than changing, or a new Renaissance.

    As regards the right to life my voting enthusiasm as regards the presidential is to defeat the Democrat Party and less so any presumption about Trump being the most reliable or insightful champion of getting the federal government out of the abortion promotion business and install actual protections for the right to life under the 14th Amendment which Trump’s platform incredibly calls on as a statement on states rights.

    Indeed my sentiment as regards Trump is that there are far worse but considerably better on any number of MAGA subjects especially as to acumen. Trump is a blunt force on subjects with his mouth, a blow hard who engages bravado and exaggeration. People respond to a positive message but Trump thinks of the population as professional wrestling fans in his own rhetorical approach. It results in messaging all over the map when it is on subjects he is shallow on, not knowing deep water.

    And the latter is the problem with Trump, as it stands now making him if not indecipherable, worrisome and likely to be “high maintenance” although with no doubt much better than Democrats. Who will have his ear on the matter of abortion and federal involvement is important. What campaign statement (or non-statement) will be operative?

    As to “ear” we are now appraised of the proximity of one perhaps as close as the pillow, and it is disconcerting to say the least. We now see that his wife Melania has put in print the most horrible formulations of a stark unlimited right to abortion. Only the autonomy of the woman is relevant, never mind that half the babies killed are female. Speaking politically, who seriously believes her comments were un-vetted? And I thought her fellow Catholic claiment Jill Biden was horrible. I was so naive I thought that it was Melania who was keeping Trump in line on the issue based on vignettes of her acting out some trappings of Catholicism — the sort which I rejected as incredibly inauthentic or even sacrilegious with the Bidens.

    And Trump and Vance have promised to aggressively inculcate IVF which is essentially a stalking horse for eugenics as it is a process of: Conceive in a Petri dish / examine and selectively transplant into one womb or another one or more human embryos (subject to later selective reduction of course) / and destroy, abandon or abuse the remaining newly conceived humans.

    Trump has criticized Republican governors on abortion when by his predilections they go “too far” protecting the right to life. He wanted to keep his platform entirely silent on abortion but then he goes and mouths off about states protecting the right to life.

    We really do not know where he is on mail order abortion poisons or which statement is operative today — support for a 20 week ban (saving just a relative few babies) as stated in HIS platform OR no federal bans period as he or his apparat have stated. If you know the current operative statement please enlighten us.

    This human epoch is being written in terms of biology and that is accomplished through the cultural transmission of bio-medical ethics. Trump has not been stellar in understanding what is at stake. He promulgated the most disastrous iatrogenic assault on the human species – the mRNA genetic manipulation, a massive program he claims credit for as saving millions of lives or something. Another one of his incredible or ignorant statements and formulations.

    And now we see claims by RFK. Jr that Trump will put him in charge of the CDC. Good huh? Maybe as regards vaccine regulation, intimidation and liability but not clearly over all. If he was consistent as to human poisons he would push to ban abortive drugs but his most recent position is supportive of Roe v Wade – a federal denial of the right to life of the unborn at any stage. His advocacy ranges from good to bad, overwrought by the unbalanced and goofy. Would that he would extend his concerns over the use of pesticides on food stuffs to drugs used as human pesticides.

    Publications like this will be essential to calling the Trump administration and Republicans in general to task in defense of the right to life and that properly encompasses being sober that: the Trump administration should it, we hope, prevail against the utterly evil Party, is shaping up to be high maintenance. Further, that looking towards 2028 Vance has been not merely dutiful but personally supportive of Trump’s troubling pre-election advocacy heretofore for what amounts to federal funding for eugenics (IVF).

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