Risk Evaluation and Mitigation Strategies
63
MENTIONS
6
EPISODES
6
PODCASTS
Search complete. 63 mentions across 6 episodes found for "Risk Evaluation and Mitigation Strategies".
Sep 25, 2026
Nielsen HobbsPANELIST
There's just sort of these, you know, vaccine issues for the most part that he's kind of worries about, but not enough to do anything on, really, it seems.
Sue SutterPANELIST
Well, he is also very interested in the myth for Preston and wants to see those REMS restrictions on in-person dispensing put back in place.
Sue SutterPANELIST
Now, the agency is conducting its own internal study on the impact of these, of lifting these restrictions in 2023.
Sue SutterPANELIST
It has to report to a federal court in early October on the status of that study.
Sue SutterPANELIST
Right.
Sue SutterPANELIST
Well, I mean, she pretty much gave both sides the same answer, that she wasn't going to prejudge.
Sue SutterPANELIST
This internal safety review is very important because FDA has not completed a safety assessment of the impact that those 2023 REMS changes have had, and she doesn't want to do anything to prejudge whatever the findings of that study will be.
Sue SutterPANELIST
She was asked by one of the Democratic members about a policy brief that she co-authored in 2023 when she was with the America First Policy Institute, where she called Mifepristone and the removal of these restrictions dangerous.
Jessica WilliamsGUEST
In the clinical trial data, at the higher dose, they were reporting out 9% of mood side effects, which is, of course, a very important consideration when we're treating teens who are experiencing a highly stigmatized condition and have a higher risk of having concerns in this area to begin with.
Jessica WilliamsGUEST
This is a REMS medication.
Jessica WilliamsGUEST
So for those of you who may or may not remember, REMS stands for Risk Evaluation and Mitigation Strategy, which means that federally it was approved under the understanding that there are notable and understood risks for teratogenicity.
Jessica WilliamsGUEST
And therefore, if you're going to prescribe this medication for Individuals who are potentially of childbearing experience, there are lots of rules around education, monitoring, contraception, etc.
Jessica WilliamsGUEST
But it is a medication that we do see some good effect coming out of.
Benjamin AguinagaUNKNOWN
Yes, Your Honor.
Benjamin AguinagaUNKNOWN
So if you look at any explanation from HHS with respect to the 2023 REMS, look at ROA 1238 to 1240.
Benjamin AguinagaUNKNOWN
This is the formal August 2022 report from HHS.
Benjamin AguinagaUNKNOWN
The title of the report is Healthcare Under Attack, and it says this is HHS's action plan in response to Dobbs.
RichmanMODERATOR
Where in the FDA's actual final order does it say, and notwithstanding it's illegal, you may mail this drug into all 50 states? Yes.
Benjamin AguinagaUNKNOWN
Well, Your Honor, I think that's in the two, I gave you one report, which is August 2022.
Benjamin AguinagaUNKNOWN
The second report, ROA 1220, that's January 2023, after the REMS has already issued, and HHS says the consequence of this is Mifflor Stone can be mailed into the states that restrict abortion.
Benjamin AguinagaUNKNOWN
That, I think, is the agency's explanation for why the REMS and the removal of the in-person dispensing requirement exists.
Surbhi SidanaGUEST
So iberdomide is a CELMoD, which for those who are familiar with myeloma practice, I think of them as immunomodulatory drugs, but better, two point O, right? They're oral.
Surbhi SidanaGUEST
They have a REMS program, which we can talk about, which is very similar, and they're given on a very similar schedule.
Surbhi SidanaGUEST
And so-- but more targeted, which means more target specific, less side effects.
Russ ConroyHOST
Gotcha.
Russ ConroyHOST
I see.
Russ ConroyHOST
Thank you for getting into detail with everything.
Russ ConroyHOST
Getting into the approval itself a little bit more, iberdomide does carry a box warning for embryo-fetal toxicity and thromboembolism, and it is only available right now through a REMS program.
Russ ConroyHOST
So how does that REMS requirement change counseling and logistics compared with existing immunomodulatory drug-based regimens that you're already managing REMS for?
Lisa JohnsonHOST
In response, anti-abortion legal organizations and state attorneys general have brought several lawsuits challenging the safety of mifepristone, one of the two drugs in the medication abortion regimen.
Lisa JohnsonHOST
In 2023, the Food and Drug Administration adjusted its Risk Evaluation and Mitigation Strategy, REMS, for mifepristone to permit telehealth-based dispensing.
Lisa JohnsonHOST
Recent litigation has sought to reverse that change and reinstate the in-person dispensing requirement for mifepristone.
Lisa JohnsonHOST
In addition to claiming that Mifepristone is inherently unsafe, a claim that has been repeatedly refuted by studies conducted over decades, anti-abortion advocates have asserted that prescribing must occur in person to prevent reproductive coercion, specifically forced abortions.
Elizabeth Tobin-TylerGUEST
They are arguing, one, that mifepristone is unsafe for women's health.
Elizabeth Tobin-TylerGUEST
They are arguing that the FDA, when it determined in 2023 through its REMS, which is the risk evaluation and mitigation strategy that is applied to medications in terms of dispensing, that their decision in 2023 to allow telehealth access to Mifepristone was wrongly decided, that it was an abuse of power, that it was arbitrary and capricious, which is legal language for describing a violation of the Administrative Procedures Act.
Elizabeth Tobin-TylerGUEST
And then another argument that they're making is that access through telehealth to Mifepristone is a violation of state sovereignty for states that have abortion bans.
Elizabeth Tobin-TylerGUEST
And then finally, what our paper is focused on is an argument that telehealth access to mifepristone supports and enables reproductive coercion that allows abusive partners to force their partner to take mifepristone against their will, causing an abortion.
Stephen MorrisseyHOST
What are the facts of that case and what developments have we seen so far?
Elizabeth Tobin-TylerGUEST
Yeah, so this case was filed in October of 2025 by Liz Merle, who's the Attorney General of Louisiana.
Elizabeth Tobin-TylerGUEST
And she alleges in that case, as I described, that the REMS for mifepristone, the FDA's both approval and also allowance for telehealth access, violates the Administrative Procedures Act.
Elizabeth Tobin-TylerGUEST
But she also argues that it's violating Louisiana's sovereignty because it bans abortion.