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.

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...

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.

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