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# Mifeprex Judge Damns FDA for Worse Abortion Outcomes
- URL: https://www.fdaweb.com/mifeprex-judge-damns-fda-for-worse-abortion-outcomes/
- Published: 2023-04-10T12:00:00.000Z
- Updated: 2026-09-14T18:24:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154168

*\[Analysis by Jim Dickinson\]* He “does not second-guess FDA’s decision-making lightly,” writes mifepristone (Mifeprex) trial pro-life judge [**Matthew J. Kacsmaryk**](https://en.wikipedia.org/wiki/Matthew%5FJ.%5FKacsmaryk?ref=fdaweb.com), a Trump appointee, in his [67-page condemnation of the abortion drug](http://www.fdaweb.com/download.php?file=Kascmaryk%5Fmemorandum%5Fopinion%5Fand%5Forder.pdf) – but he relishes doing so. The historic order, the heaviest-ever to hit the agency, would effectively undo its rushed and highly controversial 2000 mifepristone approval and ban chemical abortions nationwide if not stayed by a higher court. It accuses FDA of yielding to Clinton Administration pressure to bring the drug from France and to corruptly accelerate its approval (for only the first 10 weeks’ gestation, v. 12-24 in Europe), culpably worsening abortion outcomes for untold numbers of women who in one study were four times more likely to be injured and psychologically traumatized by [mifepristone](https://en.wikipedia.org/wiki/Mifepristone?ref=fdaweb.com) than if their pregnancies were surgically aborted.

Why the approval rush way back then? **Bill Clinton** was scheduled to turn the White House over to **George W. Bush** two months later, leaving zero chance of approval thereafter.

Kacsmaryk threads his document with graphic descriptions of chemical abortion’s unique at-home traumas, such as having to see your dead child in the toilet bowl, compared with the sanitized surgical experience in a doctor’s office. Then there’s the sheer volume of these alleged traumas: “\[T\]he number of chemical abortion-related emergency room visits increased by over *five hundred percent* (his emphasis) between 2002 and 2015,” Kacsmaryk writes. Three lines further on: “Chemical abortion patients ‘reported significantly higher levels of pain, nausea, vomiting and diarrhea during the actual abortion than did surgical patients … Post-abortion pain occurred in 77.1% of mifepristone patients compared with only 10.5% of surgical patients.”

**FDA’s fault**

And all of this is FDA’s fault, Kacsmaryk says, for twisting the law out of shape to accelerate mifepristone’s approval under 21 CFR Sec. 314 Subpart H “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses,” codified in 1992 to address the HIV/AIDS crisis. Clearly, unwanted pregnancies do not qualify. FDA did this not only to approve mifepristone, but to also “place certain restrictions on the manufacturer’s distribution of the drug product to assure its safe use,” Kacsmaryk writes. Continuing political pressure from the Clinton Administration seems to have caused the agency to abandon its proposed distribution restrictions, he suggests.

At the time, even as officials from the President on down were publicly denying it, I called Mifeprex FDA’s first political drug approval (***Dickinson’s FDA Review***, October, 2000).

Kacsmaryk’s patrons, plaintiffs Alliance for Hippocratic Medicine *et al\*,* may be considered doctors who oppose all abortions and clean up after botched ones, which he says are 20% of all. Kacsmaryk, whose federal judicial district the [*Washington Post* says is favored by “forum-shopping” conservative groups](https://www.washingtonpost.com/politics/2023/04/08/abortion-pill-ruling-judge-matthew-kacsmaryk/?ref=fdaweb.com), affords Alliance members both “standing” and “associational standing” in his courtroom, calling them “doctors and national medical associations that provide healthcare for pregnant and post-abortive women and girls.”

**First to last**

His bias is obvious to the edge of evangelism from the first to the last page of his ”Memorandum Opinion and Order,” making it more a political manifesto aimed at his chief villain, FDA, than a sober judicial examination of the facts. Why did it take the wheels of justice *two decades* (his emphasis) to bring this matter forward, he asks purely rhetorically. “After all, plaintiffs’ petitions challenging the 2000 approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review – until now.”

And so it goes, page after page. Above a footnote explaining his avoidance of the “inaccurate” word “fetus” in order to coin a new term, “unborn humans,” thereby avoiding fellow jurists’ *un*scientific ways (his emphasis) of referring to them, Kacsmaryk offers emotion-stretching language to describe how mifeprex works: it “blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death. FDA mandates a two-step regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb.” All language taken word-for-word from plaintiffs’ inflammatory filings without quotation marks, as if he were the author.

**Essential Medicines List**

Leaping from that spell-binding rhetoric, Kacsmaryk immediately plunges into more damaging, and misleading condemnation of FDA’s early-days villainy in rushing mifepristone to market (actually, the agency was one of the last in the advanced world to approve it – 12 years after France and four years before it was added to WHO’s List of Essential Medicines). Dredging plaintiff-submitted transcripts from a Republican-controlled 2006 House of Representatives Government Reform subcommittee report on FDA’s handling of mifepristone, the judge quotes chairman **Mark Souder** (R-IN), a fervent no-sex-before-marriage proponent and prominent United Brethren in Christ stalwart as saying the drug was “associated with the deaths of at least 8 women, 9 life-threatening incidents, 232 hospitalizations, 1,116 blood transfusions, and 8 cases of infection. Additionally,” Kacsmaryk continues, “chairman Souder noted ‘more than 950 adverse event cases’ associated with mifepristone ‘out of 575,000 prescriptions at most.’”

Kacsmaryk conflates the following years and FDA dosage and prescribing changes to cast the agency in a worsening light up to its 2021 decision to allow mifepristone’s distribution by mail, in direct contravention of the [1873 Comstock Act](https://en.wikipedia.org/wiki/Comstock%5Flaws?ref=fdaweb.com) “banning the *mailing* (his emphasis) of ‘\[e\]very article, instrument, substance, drug, medicine or thing’ that produces ‘abortion.’”

Then, with 60 more pages still to go in his opinion memorandum, the judge accepts without substantiating evidence the plaintiffs’ allegations that mifepristone “can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications. These emergencies, ‘consume critical limited resources, including blood for transfusions, physician time and attention, space in hospital and medical centers, and other equipment and medicines.’ This is especially true in maternity-care ‘deserts’ – geographical areas with limited physician availability. These emergencies force doctors into situations ‘in which they feel complicit in the elective chemical abortion by needing to remove a baby with a beating heart or pregnancy tissue as the only means to save the life of the woman or girl.”

**No substantiated evidence**

At this point, entirely without substantiated evidence of similar caliber to the kind that FDA daily demands on statutory insistence to justify a drug’s approval – even mifepristone’s – Kacsmaryk has built his emotional, political and religious but scarcely scientific or legal case. But he has much farther yet to go.

The next 12 pages are devoted to a dense series of complex denials of FDA’s objections to the legal standing of plaintiffs’ multiple members, from their organizations through their purported members and those members’ allegedly harmed patients – all without the plaintiffs’ need to substantiate their allegations with verifiable evidence. Kacsmaryk affirms their standings unilaterally, aided by precedents in other courts in cases far removed from FDA’s statutory duties to the U.S. population at large.

In short, the alleged patient harms giving rise to the claimed standings are extrapolated from old, unreliable data FDA would be unable to consider in reviewing drugs. Yet the judge has apparently accepted them on faith alone.

**Far sounder**

Kacsmaryk is on far sounder ground when he demolishes each of FDA’s “untimeliness” defenses against plaintiffs’ complaints that their attempts to exhaust administrative remedies at the agency were thwarted again and again by an unresponsive bureaucracy. Citing an unrelated 2015 case in Arizona, he writes that “it is ‘grossly inappropriate’ to apply a statute of limitations where the agency unreasonably delayed a claim because the agency ‘could immunize its allegedly unreasonable delay from judicial review simply by extending that delay for six years.’ It took the notoriously lethargic FDA “13 years, 7 months and 9 days to respond to the 2002 petition. FDA then moved the goalposts by substantially changing the regulatory scheme on the *same day* (his emphasis) it issued its response. And it took FDA 2 years, 8 months, and 17 days to respond to the 2019 petition which challenged those changes. Thus, in the 20 years between the 2002 petition and the filing of this suit, plaintiffs were waiting for 16 of those years.”

Similarly, Kacsmaryk scores accurately when he shoots down all of FDA’s defenses of its decision to allow mailing of mifepristone from abortion-permitting states into abortion-banning states. The Comstock Act plainly prohibits that and federal agencies have no legal ability to exercise “enforcement discretion” in order to get around it.

Next step: The Fifth Circuit Court of Appeals or the U.S. Supreme Court is expected to rule on the government’s swiftly filed appeal of Kacsmaryk’s order. The circuit has [seven Democrats and 19 Republicans](https://www.ca5.uscourts.gov/about-the-court/fifth-circuit-judges?ref=fdaweb.com).

*\*Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, Shaun Jester, D.O., Regina Frost-Clark, M.D., Tyler Johnson, D.O. and George Delgado, M.D.*