top of page

FDA Panelists Vote to End Clozapine REMS

On November 19th, 2024, the FDA held a historic joint meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee on the reevaluation of the Clozapine Risk Evaluation and Mitigation Strategy (REMS).


A recording of the entire event is available here:

Open public testimony starts at 5:39:40.


For the first time in history, individuals harmed by the clozapine REMS had the opportunity to share these experiences with the FDA and industry representatives.


The courageous personal testimonies of Neesa (6:08:20), Analisa (6:23:25), Max (6:26:08), Javan (6:32:16), and Joni (6:35:29) provided powerful insight into living with psychosis and the stigma and harm caused by the FDA’s rigid, discriminatory, and at times dangerous clozapine REMS program. Thank you for giving a voice to the voiceless. You are our true heroes, and you are why we fight.


Several members of The Angry Moms, the Arizona Mad Moms, and other caregivers shared about the impact of treatment delays and interruptions due to the clozapine REMS. Never have members of our community been given the opportunity to share their experience in this way to inform life-altering policy change.


Our black T-shirts proclaimed our unified statement that “CLOZAPINE is the SAFEST Antipsychotic in the WORLD.” This refers NOT to the short-term management of clozapine's adverse effects, but to long-term epidemiological data showing clozapine patients live significantly longer than those treated with other antipsychotic medications. The fatal risks of clozapine are miniscule in relation to the lives saved.


Our stories concluded with the powerful statement that the greatest risk of clozapine is not getting clozapine.


We appreciate and wish to acknowledge the other public speakers who joined us, especially the providers who have dedicated their lives to the field of psychiatry with the singular goal of promoting meaningful recovery from psychosis. We are particularly grateful to those who emphasized how clozapine treatment parameters have disproportionately affected Black patients, ethnic minorities, young populations, and the most acutely ill who cannot participate in rigid invasive blood testing.


We want to sincerely thank the Schizophrenia & Psychosis Action Alliance for building a collaborative alliance and working tirelessly behind the scenes to get this joint FDA committee hearing scheduled. We are also grateful for the support we received from individuals, advocacy groups and innovators in clozapine treatment, which includes, but is not limited to Dr. Gil Honigfeld, Dr. David Taylor, Dr. Raymond Love, Dr. Deanna Kelly, US Congressman Brad Sherman, representatives from Athelas (finger stick ANC devices), Golden Gate Pharmacy, Team Daniel Running for Recovery, Treatment Advocacy Center, National Shattering Silence Coalition, Doromind, Myogenes, and NAMI.


Thank you also to the media for covering our stories and our plight, especially journalist Ally Markovich, a neutral reporter who has been walking alongside the families and advocates, observing and documenting our preparation and involvement in this historic effort for the mentally ill.


Thank you to the committees and panelists. We felt your support and appreciated your comments and questions.


We applaud your votes, 14 to 1, in favor of ending the clozapine REMS certification and ANC documentation requirements. Even the lone dissenter qualified their vote with statements that any continued REMS should be time-limited and “streamlined.” We also applaud the inclusion of Michael Brisbin as a patient representative. His insightful questions to the FDA exposed the clozapine REMS as the only REMS program in history to require weekly blood testing of patients.


Thank you to the FDA for convening these committees and for assuring that our stories and our shared experience will have an impact on regulatory decision making.


We look forward to meaningful change.


The Angry Moms


Recent press coverage:








Comments


Kathy Weyandt Jackson
a day ago

So incredibly thankful to you Rachel and all our other fearless leaders. I watched nearly all of the hearing and was proud as heck to be an Angry Mom. Since then, my son has gone for his monthly labs twice in one week due to lab error. Now his doctor says he has to go again (third time this month) because the lab can’t seem to get it right. Thank goodness we have a bit of a stash. Thanks again to you all!


If you are in Minnesota, join NAMI Ramsey County for a public screening of Team Daniel’s documentary, “Into the Light” followed by a Q & A with Dr. Laitman and/or Dr. Mandel. Wednesday, February 12th @ 6pm…

Like

Angry Dad
Nov 27

Thanks AMs and all who contributed on behalf of my son who is on week 15 of Clozapine in a jail.


FDA has to act within 90 days by law. Article below says Milank research indicates FDA follows rec from adcoms 80 pct of time. Closer vote elevates chance of not following.


https://medcitynews.com/2019/07/fda-often-goes-against-advisory-committee-recommendations-when-votes-are-divided-study-finds/#:~:text=A%20study%20published%20Sunday%20in,the%20time%20they%20were%20not.


Like

Guest
Nov 24

Well Done!!!

Like

Nabil F.
Nov 23

A powerful stride toward dismantling the chaos of mental healthcare in the USA! Deep gratitude to all who dared to drive this transformative change.

Like

Guest
Nov 23

Words cannot express how thankful I am to everyone mentioned here and those behind the scenes fighting!! My son has his life back because of clozapine and I want the same for all!!

I’m literally crying. Thank you!

Like
bottom of page