Mifepristone access banned and expanded

So as you might have heard, this happened on Friday.

U.S. District Judge Matthew Kacsmaryk in Texas stayed the Food and Drug Administration’s (FDA) approval of abortion drug mifepristone nationwide Friday, including in blue states with robust abortion protections.

The ruling will take seven days to go into effect; the Department of Justice immediately appealed it.

“My Administration will fight this ruling,” President Joe Biden said in a statement. “The Department of Justice has already filed an appeal and will seek an immediate stay of the decision.”

The same night, a separate judge in Washington state issued an order stating exactly the opposite: that the FDA maintain “the status quo” in terms of access to the drug in the states involved. The Department of Justice said in a statement it was reviewing the Washington decision.

The conflicting opinions make it highly likely the question will soon end up before the Supreme Court.

It’s not immediately clear what the effect of either ruling will be: The FDA has unfettered enforcement discretion, and there are plenty of drugs without approval on the market.


The Texas decision was expected by all involved — Kacsmaryk, a Donald Trump appointee, is a constant Biden administration antagonist. He presides over all cases filed in Amarillo, and right-wing litigants have learned to file there to be sure they’ll get a judge sympathetic to their cause.

His decision is peppered with anti-abortion language and sentiment. “Because mifepristone alone will not always complete the abortion, FDA mandates a two-step drug 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,” he writes. He also refers to providers as “abortionists” throughout.

He regurgitates the common anti-abortion lies that mifepristone is dangerous, blatantly disregarding the consensus of the medical community, and that abortions cause women overwhelming emotional distress and regret.

His handling of the case has been at times bizarre and drawn scrutiny, including an attempt to keep a key hearing in the case secret from the press and the public until the last minute.

That Kacsmaryk has the power to issue a nationwide injunction from just one case only makes the conservative goal-to-sweeping result pipeline even more of a glidepath.

Should the Texas case be appealed, there’s not much guaranteed salvation ahead for supporters of abortion access (and those who support miscarriage carecancer care and the many other medical treatments that involve abortions). The case will next go to the famously right-wing Fifth Circuit Court of Appeals, then, presumably, to the majority anti-abortion Supreme Court.

Over in Washington, a coalition of Democratic attorneys general filed suit to expand access to mifepristone, arguing that the FDA should lift its years-old restrictions that major medical organizations have long argued are rooted in politics, not science. While the Biden administration made the drug somewhat easier to obtain this January — including allowing certified pharmacies to dispense it — it maintained other restrictions.

In his opinion ordering that mifepristone be kept available, Judge Thomas Rice pointed out that “the record demonstrates potentially internally inconsistent FDA findings regarding mifepristone’s safety profile,” citing the fact that mifepristone prescribed for Cushing’s disease — rather than abortion — is not subject to those onerous restrictions.

Another countervailing lawsuit is still playing out in West Virginia, where a maker of mifepristone is suing West Virginia, arguing that its abortion ban is violating both the Supremacy and Commerce Clauses of the Constitution in overriding the FDA conclusion that the drug is safe.

See here and here for some background; the opinions are embedded in the story above. I had a draft a couple of days ago about the hearing for the mifepristone-expansion lawsuit but didn’t publish it in time; I’ve put that post beneath the fold, as the arguments made during the hearing are worth reading. There’s been a ton of commentary already – see here, here, here, here, here, here, and here for so much more. I don’t have anything to add to all that, but I did find it grimly amusing that the long-awaited and feared Texas decision came down a couple of days after State Supreme Court Chief Justice Nathan Hecht said this;

Texas Supreme Court Chief Justice Nathan Hecht called on state lawmakers Wednesday to increase judicial salaries and create a new court system to handle disputes between businesses.

The comments came in his biennial speech on the state of the judiciary, during which he also cautioned against the increasing politicization of the third branch of government. He cited the recent Wisconsin Supreme Court election in which the winner was an outspoken liberal, and comments by former President Donald Trump and a Democratic U.S. senator characterizing court rulings as partisan.

“I grow concerned that political divisions among us threaten the judicial independence essential to the rule of law,” Hecht, a Republican, said in the Texas Supreme Court courtroom in Austin. “The left and right, and leaders in both the executive and legislative branches, are in agreement: Judges are not independent, and shouldn’t be; they should take sides — my side.”

He urged judges against partisan decisions, saying the pressure to comply with politics “destroys the rule of law essential to justice for all.”

Both the Texas Supreme Court and Texas Court of Criminal Appeals, the highest court for criminal matters in the state, are made up of all Republicans.

You couldn’t find a more blatant example of this than Matthew Kacsmaryk, whose only qualification for the bench, for which he was hand-selected by the radical conservative legal movement, was his anti-abortion activism. There’s a reason why so many cases, filed by Ken Paxton and various zealots of that movement, get heard by him. Please update your references for future use, Justice Hecht.

Hope for the best, even if it likely won’t have any effect here.

A coalition of Democratic attorneys general are pushing the Food and Drug Administration to expand access to mifepristone, one of the drugs commonly prescribed to induce abortions — a bid to counter a high-profile attempt to restrict it in Texas.

This case has gotten significantly less coverage than anti-abortion groups’ efforts to revoke the FDA’s 20-year approval of the drug in Judge Matthew Kacsmaryk’s court in Amarillo, Texas. TPM first reported a transcript in the Texas case detailing the judge’s attempt to keep a major hearing off the public docket until the last minute to prevent protests.

In the AGs’ case, spearheaded by Washington state, the Democrats are pitted against the Democratic administration, which does not want to have to lift its restrictions on mifepristone. It relaxed some of those restrictions in January — including allowing certified pharmacies to dispense the drug rather than just individual providers — but kept many others. Major medical associations have long said that the restrictions, known as a Risk Evaluation and Mitigation Strategy, or REMS, are unnecessary; they’re usually reserved for drugs known to have addictive or dangerous qualities, like fentanyl.


Kristin Beneski, an assistant Attorney General for Washington, said that the plaintiffs want two things: the FDA to have to keep the drug on the market in the states involved no matter what happens in the Texas case, and for the agency to be enjoined from enforcing the mifepristone REMS.

“This is pure preservation of the longstanding status quo, and it’s crucial in part because the FDA is a party to a case in Texas that seeks to undo its longstanding approval of this extremely safe and effective drug,” she argued.

Beneski said that access to the drug is more critical than ever before, given the anti-abortion regimes dominating many parts of the country.

Judge Thomas O. Rice jumped in at times, trying to lock down which REMS restrictions stem from the January 2023 modification, and which have long been on the books — perhaps a sign that he’s not buying the AGs’ attempt to use the January order to challenge all the restrictions, even the years-old ones.

Beneski attempted to underscore the arbitrariness that has always accompanied the mifepristone REMS.

“For abortion and miscarriage care, you take one 200-milligram pill one time. That is subject to onerous REMS restrictions,” she said. “If you take Mifepristone for Cushing’s disease, it’s a 300-milligram pill up to four times a day every single day over the long-term, and there are no REMS restrictions on that usage,” she added, calling it “the definition of arbitrary and capricious.”

Noah Katzen, representing the U.S. Attorney General’s office, argued that the plaintiffs have failed to show irreparable harm — saying that the January REMS modification made the drug more accessible, not less — and that they failed to exhaust all the potential administrative challenges they could have tried.

“Their relief would have to run against the final agency action,” he argued. “They’ve challenged the final agency action that they say is unlawful; so the question for redressability on standing is would an order that runs solely against the agency action that they are challenging here redress their injuries? They have offered no theory as to how it would. They have not alleged that it would.”

Rice jumped into Katzen’s arguments too, asking which other drugs require special pharmacy certification. Katzen couldn’t name one.

On rebuttal, Beneski argued that the harms involved are new since the Dobbs decision.

“Before the Dobbs decision, no one could be prosecuted for providing or facilitating an abortion or miscarriage care that might be characterized as an abortion,” she said. “That is an irreparable harm by itself to our state providers who have to sign these forms and who have to get certified and identify themselves as abortion providers and put themselves in danger by getting certified.”

Rice promised a decision as “promptly” as he can.

See here for the background. I looked around for other coverage of this but didn’t find any. It is not clear to me what a favorable ruling for the plaintiffs could mean, but I’d be more than happy to find out. As for the unhinged Texas anti-mifepristone lawsuit, which had its hearing three weeks ago, who knows. I’m just trying to grab the good news where I can.

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4 Responses to Mifepristone access banned and expanded

  1. Pingback: We await what’s next with mifepristone – Off the Kuff

  2. C.L. says:

    For a political party who’s hyper-focused to rid the populace of pesky gov’ment rules and get the overbearing presence of State/Fed regs out of our lives, it sure seems they are consistently doing everything in their power to maintain an unhealthy control of their constituents by doing the exact opposite of that.

    Quite the paradox, that is.

  3. Pingback: Monday mifepristone update – Off the Kuff

  4. Pingback: Fifth Circuit barely limits ridiculous anti-mifepristone ruling – Off the Kuff

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