Greer Donley

Update on the interstate conflict over abortion. A NY court sided with a county clerk who refused to enter a motion to enforce Texas's judgment against a NY doctor. Why? The state's shield law prohibits him from helping Texas in its suit against NY doctor acting lawfully under NY's shield statute.

Great thread about the good decision in Hawaii yesterday. Too much attention has been paid to the antiabortion challenges to mife and not enough to the prochoice challenges to its overregulation.

There's this case and two other federal cases - in Washington and in Virginia.

Finishing up arbitrary and capricious review for leg-reg this morning, where I had students read the 5CA alliance opinion w FDA's SCOTUS brief. Now my students can be really confused! Courts have found the mife REMS a&c b/c FDA failed to justify why it shouldn't have been stricter AND more lenient.

If you want to learn more about the mife REMS and why it should be removed entirely, read my article "Medication Abortion Exceptionalism" in Cornell Law Review. I actually discuss this case quite a bit, and it's awesome to finally see a summary judgment order! papers.ssrn.com/sol3/papers....

The FDA has said it is reviewing mifepristone's safety, which could be real or could be bluster. If any review is happening, this case places opposing pressure on the agency. It also potentially sets up another split if the MO and LA cases go as expected.

It is the complete opposite of the Alliance case, but with an oddly similar holding. Though unlawful, the 2023 REMS will remain in effect. The court remanded back to the FDA to reconsider the REMS modification in light of the statutory factors and evidence it didn't properly consider.

Good News that sounds like bad news: The District of Hawaii just found the FDA's 2023 mifepristone REMS modification unlawful and arbitrary & capricious! It's good news b/c the case was brought by medical orgs & docs arguing that FDA failed to justify why it kept strict & unnecessary REMS elements.

👇👇

Now in @jama.com: @greerdonley.bsky.social, Lewis Grossman & I explain that these preemption cases, while specifically about mifepristone, have implications for FDA and state drug regulation, biomedical innovation, and patient access more generally.

jamanetwork.com/journals/jam...

State Mifepristone Regulation Following GenBioPro v Raynes This Viewpoint discusses the GenBioPro v Raynes decision and what it could mean for other cases challenging medication abortion restrictions on preemption grounds.

Indeed, the 4th Circuit will be deciding another preemption case (Bryant v. Stein) soon, which challenges North Carolina's medication abortion laws. We argue that the preemption arguments in this case are stronger & the case may come out differently. jamanetwork.com/journals/jam...

Curious what the 4th Circuit's opinion in GenBioPro v. Raynes means for state mifepristone regulation? Check out my new piece with @pzettler.bsky.social & Lewis Grossman in JAMA. We argue that preemption arguments are not dead, even though the court upheld WVA's abortion ban. 1/2

This is bad, but also interesting how hard republicans are having to work to pressure the FDA under Trump to make any changes to the mife regulation (litigation, appeals from AGs, senators, religious leaders, etc.) Suggests to me that they don't think it's already coming?

I think LA thinks it's found a great plaintiff for standing purposes here. But they haven't. For very clear reasons -- someone injured in the past like this doesn't have standing for future-looking injunctive relief.

This woman can sue for damages for harm she suffered, but not for an injunction.

Good thread

Great thread about the "new" case challenging FDA allowing mailed abortion pills.

Finally, and not surprisingly, LA argues that removing the REMS is unlawful bc of Comstock. This is not new, but worth mentioning bc Comstock doesn't come up a lot these days. Here it the complaint. s3.documentcloud.org/documents/26...

Third, LA also argues it's injured b/c FDA law preempts their abortion laws. That would be great news! Unfortunately, the 4th Circuit just ruled that FDA regulation did not preempt West VA's abortion ban. More cases on that issues are coming & could turn out differently, but it's at best unsettled

For the REMS change, FDA was evaluating telehealth for abortion that was already happening--i.e., providers licensed in state X providing telehealth + mailed pills to patients in state X. (This was already happening b/c of COVID. Learn more here: papers.ssrn.com/sol3/papers....)

That first shield law did NOT include telehealth across state lines. It wasn't until NY passed its telehealth shield law in summer 2023 that shield providers started providing interstate telehealth abortions. This was nearly six months after FDA finalized its updated REMS.

FDA announced its decision to permanently remove the in-person dispensing requirement in Dec 2021, months before Dobbs & before shield laws were even a concept. (@dsc250.bsky.social @rebouche.bsky.social & I worked w Matt Blumenthal to design the 1st shield law in CT in the spring of 2022.)

Second, part of LA's standing argument is that FDA *intentionally* modified the REMS to permit shield provision--i.e., to allow providers in shield states to ship medication to patients in red states after Dobbs. This is just factually incorrect.

It is clearly an antiabortion strategy to argue that telehealth for abortion is dangerous b/c it makes coerced abortions easier. (Note: these are very rare stories, but if true, are unequivocally awful, and we should be really clear about that. But the sought-after remedy is extremely over broad.)

First, there is second plaintiff, a LA woman, who is arguing that her boyfriend coerced her to take abortion pills, which would have been prevented with in-person dispensing. We have heard her story before, so it's not new, but previous litigation against FDA didn't have an actual patient.

NEW-ish: Louisiana is suing FDA over its 2023 REMS change for mifepristone, which removed the in-person dispensing requirement. That change allowed mail or pharmacy dispensing of mife after significant data showed it was safe and effective. A few things to note about this new lawsuit.

Thanks for sending this to me! I wouldn't have seen it otherwise!

@autonomynews.co received a tip yesterday about concerns that the FDA seemed to have made some sort of change regarding mifepristone.

As it turns out, it wasn’t bad news—a new generic has been approved.

This is bonkers. The antiabortion movement has put a full court press on FDA to restrict mifepristone, and everyone is on edge that it will do so.

So what does FDA do? It approves a new generic mifepristone without changing anything about the restrictions.

Thank you RFK? ?!?!

This feels very business as usual, which is interesting. I did a redline of the FDA letters to the manufacturer, which are on the REMS page, from Jan 2023 and Oct 2025, and there didn't seem to be any substantive changes in the assessment plan.

NEW: On Tuesday, FDA approved a new generic for mifepristone from Evita Solutions. The FDA also modified the shared REMS for mifepristone to include the new generic. You can see the company's announcement here: www.evitasolutionsllc.com

I think David is exactly right, although I guess if I had to try to read the crystal ball, I'd lean in the direction that Trump will eventually do something on mifepristone. But it's unclear what, and it could take years. This letter buys them time to figure it out & make the political calculation.

Pa. Supreme Court justices join panel to push back against campaign to oust them The three Democratic justices argued that partisanship does not guide their decisions. They face an unprecedented effort to unseat them.

🚨 Vote 11/4! -> State supreme court decisions determine our rights & freedoms! And we get to decide who makes those decisions! whyy.org/articles/pen...