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Greer Donley @greerdonley.bsky.social · 1d

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?

Susan Rinkunas @susanrinkunas.com · 1d

NEW: 51 Senators urge RFK Jr. and Marty Makary to end telemedicine prescriptions of the abortion drug mifepristone— and to suspend its distribution as an "imminent hazard" under Federal Food, Drug, and Cosmetic Act. Collins and Murkowski only GOP members not to sign
justthenews.com/sites/defaul...

screenshot of letter dated 10/9/25
Today, your agencies have all the information they need to bring an end to previous Democrat-administrations’ abortion drug regulations while a comprehensive review is conducted. As a starting point,
we recommend the following:
1. Suspend the approval of any new generic versions of mifepristone pending the outcome of the REMS safety review;
2. Commit to ensuring that all generic versions of mifepristone are included in the ongoing reevaluation of prior REMS approvals;
3. Reinstate the in-person dispensing requirement for mifepristone and all its generic versions;
4. Suspend the distribution of mifepristone and all generic versions as an “imminent hazard” under Section 505(e) of the Federal Food, Drug, and Cosmetic Act (FDCA); and
5. Withdraw FDA guidance permitting pharmacy distribution of mifepristone and all its generic versions.

We are committed to continuing to work together to give a voice to the voiceless and protect women from the dangerous effects of unregulated access to chemical abortion drugs. The life, safety, freedom, and health of millions of Americans, born and unborn, depend on it.

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Reposted by Greer Donley

David S. Cohen @dsc250.bsky.social · 1d

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.

Greer Donley @greerdonley.bsky.social · 1d

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.

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Reposted by Greer Donley

Hank Greely @hankgreely.bsky.social · 1d

Good thread

Greer Donley @greerdonley.bsky.social · 1d

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.

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Reposted by Greer Donley

David S. Cohen @dsc250.bsky.social · 1d

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

Greer Donley @greerdonley.bsky.social · 1d

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.

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Greer Donley @greerdonley.bsky.social · 1d

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...

s3.documentcloud.org

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Greer Donley @greerdonley.bsky.social · 1d

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

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Greer Donley @greerdonley.bsky.social · 1d

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....)

Abortion Pills

Abortion is now illegal in roughly a third of the country, but abortion pills are more widely available than ever before. Though antiabortion advocates and legi

papers.ssrn.com

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Greer Donley @greerdonley.bsky.social · 1d

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.

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Greer Donley @greerdonley.bsky.social · 1d

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.)

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Greer Donley @greerdonley.bsky.social · 1d

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.

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Greer Donley @greerdonley.bsky.social · 1d

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.)

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Greer Donley @greerdonley.bsky.social · 1d

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.

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Greer Donley @greerdonley.bsky.social · 1d

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.

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Greer Donley @greerdonley.bsky.social · 8d

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

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Reposted by Greer Donley

Garnet Henderson @garnethenderson.com · 8d

@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.

Greer Donley @greerdonley.bsky.social · 8d

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

Evita Solutions - Generic Mifepristone Available Today

Evita Solutions LLC's FDA-approved generic Mifepristone Tablets, 200 mg for safe, effective medical abortion up to 70 days.

www.evitasolutionsllc.com

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Reposted by Greer Donley

David S. Cohen @dsc250.bsky.social · 8d

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? ?!?!

Greer Donley @greerdonley.bsky.social · 8d

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

Evita Solutions - Generic Mifepristone Available Today

Evita Solutions LLC's FDA-approved generic Mifepristone Tablets, 200 mg for safe, effective medical abortion up to 70 days.

www.evitasolutionsllc.com

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Greer Donley @greerdonley.bsky.social · 8d

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.

Approved Risk Evaluation and Mitigation Strategies (REMS)

www.accessdata.fda.gov

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Greer Donley @greerdonley.bsky.social · 8d

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

Evita Solutions - Generic Mifepristone Available Today

Evita Solutions LLC's FDA-approved generic Mifepristone Tablets, 200 mg for safe, effective medical abortion up to 70 days.

www.evitasolutionsllc.com

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Greer Donley @greerdonley.bsky.social · 16d

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.

David S. Cohen @dsc250.bsky.social · 17d

I still maintain that this is exactly what you would write if:

1) You were studying the matter and looking to restrict mifepristone.

OR

2) You had no intention to study the matter or restrict mifepristone but wanted the people nagging you to get off your back.

I have no crystal ball.

Susan Rinkunas @susanrinkunas.com · 17d

As I was saying... Susan B. Anthony Pro-Life America blasted out a letter obtained by Gateway Pundit (lol) in which RFK and Marty Makary tell Republican AGs that they "will conduct a study on the safety" of current abortion pill regulations, namely allowing telemed RX
sbaprolife.org/newsroom/pre...

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Reposted by Greer Donley

Women's Law Project @womenslawproject.bsky.social · Sep 10

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

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.

whyy.org

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Greer Donley @greerdonley.bsky.social · Sep 10

(The abortion charge is a second-degree felony, so potentially 20-years in prison, not life. Correcting myself there!)

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Greer Donley @greerdonley.bsky.social · Sep 10

I wish more people were talking about this case as the prosecution of miscarriage care. More on the case here: www.houstonchronicle.com/news/houston...

Exclusive: Houston midwife indicted on 15 felonies in abortion case

Maria Rojas, a Houston-area midwife, faces 15 felony charges, including counts of practicing medicine without a license and performing abortions.

www.houstonchronicle.com

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Greer Donley @greerdonley.bsky.social · Sep 10

So when people say: "abortion bans exclude miscarriage" & point to the definitional exclusion in the law, this fails to understand the ambiguities btwn abortion & miscarriage. I wrote a long article on this, Abortion Disorientation, which you can check out here: papers.ssrn.com/sol3/papers....

Abortion Disorientation

The word “abortion” pervades public discourse in the wake of <i>Dobbs v. Jackson Women’s Health Organization</i>. But do we know what it means? Not only do law

papers.ssrn.com

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Greer Donley @greerdonley.bsky.social · Sep 10

Perhaps there was a mistake about whether the pregnancy was viable. If so, that should be a medical malpractice question. But prosecuting her for a felony with potential life in prison for a potential mistake about fetal viability should explain fully why bans are chilling miscarriage care.

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Greer Donley @greerdonley.bsky.social · Sep 10

Maria Rojas, a midwife in TX, was arrested in June for allegedly providing illegal abortions. But the indictment only has details about 1 case, which shows that Rojas was providing miscarriage care ‼️ The witness says Rojas prescribed misoprostol b/c she thought the pregnancy was not viable.

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