Mifepristone access, and what comes next for the medication abortion drug

A look at how the incoming Trump administration is shaping up — and how pending litigation could force their hand on abortion questions early in 2025.

The future of mifepristone access is up in the air on multiple fronts right now — just five months after the U.S. Supreme Court rejected a challenge to the U.S. Food and Drug Administration’s treatment of the medication abortion drug.

In June, a unanimous Supreme Court held that the private plaintiffs challenging the FDA’s rules surrounding mifepristone access lacked standing to bring their claims. At that point, the challenges had already been whittled down. They were not to the original approval of mifepristone itself but to the 2016-and-since changes to access of the drug, including allowing the mailing of the drug by ending the in-person dispensing requirement and increasing the gestational limits on when mifepristone can be used.

Now, though, Donald Trump has won election to the presidency — and questions about what his new administration will do to federal policy surrounding the drug are front and center. Additionally, moves in recent weeks in existing litigation suggest that neither backers of the drug’s availability nor those seeking to restrict its access are willing to sit back and wait for the Trump administration to act.

The result could be a flurry of litigation in the coming months, some all but forcing the Trump administration to quickly weigh in on the matter and, potentially, sending one or more questions back to the Supreme Court sooner rather than later.

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The Trump administration

Relevant to the mifepristone litigation, Trump has announced that former Florida Attorney General Pam Bondi is his nominee for attorney general, Robert F. Kennedy Jr. is his nominee to run the Department of Health and Human Services, and Marty Makary is his nominee to run the FDA.

Since the election, anti-abortion groups and activists have been “emboldened,” as The Washington Post reported, despite abortion protections passing almost everywhere they were on the ballot. There will be efforts to push the administration to adopt anti-abortion positions, but, beyond that, those same groups will be going to court regardless of what the new administration does.

Although far-right groups like Project 2025 were advocating for a Trump administration to resurrect and use the 1873 Comstock Act to prevent mailing of mifepristone (and, potentially, any other “article or thing” used in an abortion, under reasoning I described in this article), neither Trump nor any of these key nominees have backed such a step.

Although Bondi certainly identifies as “pro-life,” the primary case cited from her time as Florida attorney general is her 2016 defense of a Florida law requiring a 24-hour waiting period before a woman or other pregnant person could get an abortion. It is important to remember that she left office more than three years before Roe v. Wade was overturned. As such, limits in her arguments in the case don’t tell us — in either direction — what her views would be today.

The brief she filed in the case at the Florida Supreme Court is largely an ordinary government brief defending a state law, with several procedural arguments taking up the majority of the filing. But, on the substantive argument in defense of the law, here is her summary:

The interest advanced by the New Law is compelling: protecting pregnant women from undergoing serious procedures without minimal private time to reflect on the risks and consequences just revealed to them, while maintaining the integrity of the medical profession. The means of protection is minimal: a brief 24-hour window after receiving critical information, away from potentially coercive circumstances.

The Florida Supreme Court sided with the challengers, keeping the trial court’s injunction against enforcement of the waiting period in place. Here is what then-Justice Barbara Pariente wrote in part:

Whether it is a good idea to mandate that women seeking to terminate their pregnancies wait a minimum of an additional twenty-four hours before allowing them to receive medical treatment is not the point.… [T]hrough the Mandatory Delay Law, the State impermissibly interferes with women’s fundamental right of privacy by mandating an additional twenty-four hour waiting period before a woman may exercise her decision after receiving all of the information the state deems necessary to make an educated and informed decision.

Aside from that case, I would also note that, as attorney general, Bondi joined a multistate amici brief at the Supreme Court supporting Texas’s law restricting who could provide abortions and where they could be provided by requiring doctors performing abortions to have admitting privileges at a nearby hospital and clinics where abortions were performed to meet the requirements for ambulatory surgical centers. The brief, led by Indiana and Ohio, backed Texas’s law, and Bondi, representing Florida, signed onto it. The Supreme Court, in the 2016 decision in Whole Woman’s Health v. Hellerstedt, ruled against Texas.

Since then, she has been a hardline Trump backer, both defending him in his first impeachment and then working with the America First Policy Institute in the run-up to the election — which has only a limited federal policy proposal relating to abortion in the relevant section of its policy agenda. It’s hard to pin down where she will land, policy-wise, in the attorney general’s office, but it’s almost certain to be what Donald Trump wants.

Kennedy, meanwhile, has been supportive of abortion rights in the past in accordance with his focus on medical autonomy, although he did express support for a post-viability abortion ban, with exceptions, during his short lived presidential campaign. His general support for abortion access nonetheless is causing problems for his nomination from the right, as coverage continues to highlight.

Makary, on the day the Supreme Court overturned Roe, expressed — at best — discomfort with abortion that an abortion rights group criticized as “anti-abortion disinformation.” Catholic Vote, meanwhile, celebrated the fact that Trump was nominating a “pro-life physician” to run the FDA. It should be noted, however, that virtually all public discussion of Makary’s views on abortion appear to come from analysis of the June 24, 2022, Fox News interview with Tucker Carlson.

In short, while anti-abortion advocates are going to be pushing for, and future nominees could signal, a far-right move on abortion, it is not clear yet how much further right Trump or these nominees are going to want to go than the status quo.

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The litigation

That said, there are many steps before invoking the Comstock Act that would make the lives of women and others seeking abortions significantly more difficult depending on what happens in the coming months.

After the Supreme Court’s decision in the mifepristone case, I noted a potential issue for the future:

[A] trio of conservative states have intervened in this challenge at the district court before [U.S. District Judge Matthew] Kacsmaryk, something that I have written about previously. Adam Unikowsky, though, has written about how a ruling that the original plaintiffs lack standing — i.e., what we got on Thursday — should be sufficient to end the case altogether because that would mean the court never had jurisdiction to hear the case. It is Kacsmaryk, however, so whether that’s what happens remains to be seen.

Well, the future is here.

Missouri, Kansas, and Idaho — the trio of states — filed a motion on Oct. 11 to amend their complaint in the case, basically, to add to it in light of new information and in the wake of the Supreme Court’s standing ruling.

On Nov. 1, however, the Justice Department filed a motion to dismiss the case, as well as a memorandum of law supporting that and opposing the states’ request to amend their complaint because, the lawyers wrote, “Once Plaintiffs’ Complaint is dismissed, the separate Complaint filed by the three Intervenor States—the States of Missouri, Idaho, and Kansas (“the States”)—must likewise be dismissed. The Fifth Circuit has squarely held that intervention requires a jurisdictionally proper suit. Because this Court never had jurisdiction over Plaintiffs’ claims, it could not obtain jurisdiction over the States’ claims.“ Danco Laboratories, the maker of Mifiprex, filed a similar motion and argument.

The trio of states responded to that on Nov. 15, arguing that, “Because Defendants cannot show that this Court’s intervention order was ‘clearly erroneous,’ the Court can permit the States’ suit to proceed.”

A few days later, on Nov. 19, the original private plaintiffs — the ones who established a group based in Texas to file a lawsuit that would be heard by Kacsmaryk — filed a notice that they were voluntarily dismissing their lawsuit.

On Monday, Kacsmaryk filed an order that amounted to his acknowledgement of that notice.

Within it, though, was one additional statement: “All claims by Intervenor Plaintiffs remain at this juncture.”

So, at least for now, Kacsmaryk — who originally tried to block the drug altogether and nationwide — is asserting that he maintains jurisdiction over claims brought by the intervening states despite the Supreme Court unanimously holding that the original plaintiffs lacked standing and those original plaintiffs now no longer even being parties to the case.

DOJ and Danco’s replies in support of their motions to dismiss the remaining complaint from the trio of states are due Dec. 6.

Most important to all of this is what happens if Kacsmaryk rejects DOJ’s request or does not rule by Jan. 20. At that point, although Danco’s position isn’t likely to change, it is possible that DOJ and the FDA’s position in the case could change. If not dismissed by Jan. 20, then, it is very possible that this case could force the new Trump administration to very quickly weigh in on these questions about mifepristone access.

Remarkably, that is not all.

In a less closely watched case, a group of Democratic-led states sued the FDA in Washington to protect — and, in fact, expand — access to mifepristone. The case had been in a holding pattern while some Republican-led states unsuccessfully sought to intervene in the case, but it recently got going again.

The Democratic-led states filed their motion for summary judgment in October, arguing that mifepristone should not be subject to “special restrictions” when “[i]t is even safer than such well-known drugs as Tylenol, Viagra, and insulin” that have no such restrictions.

On Monday, U.S. District Judge Thomas Rice granted an agreed request from the parties to move the remaining deadlines in the briefing schedule slightly, with the federal government’s final brief not due until March 12, 2025. (To be clear, the briefing was not going to be complete until after the administration changes even under the earlier briefing schedule.)

As such, the FDA and DOJ’s position in the case could change next year. Regardless, DOJ will have to file this reply brief less than two months into the new administration.

Similar challenges brought by medical providers are pending in federal court in Hawaii and Virginia. The plaintiffs in the Hawaii case filed their motion for summary judgment on Oct. 2, and the plaintiffs in the Virginia case did the same on Oct. 23.

There also is an ongoing challenge brought by the generic maker of mifepristone, GenBioPro, before the U.S. Court of Appeals for the Fourth Circuit over West Virginia’s mifepristone restrictions — with the drugmaker arguing that the restrictions are preempted by federal law. Arguments were heard Oct. 29 in that case. A similar preemption case, brought by a doctor, challenging North Carolina’s mifepristone restrictions is pending at the Fourth Circuit.

GenBioPro also filed litigation in federal court in Maryland back in 2023 seeking to protect its interests. As litigation proceeded elsewhere, the case has basically been in a holding pattern and is stayed currently.¹

And, of course, there will be new litigation.

There are 54 days until Trump takes office.

1. This paragraph and the two preceding it were added after initial publication, with the final edit at 3:00 p.m.