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Urgent: Please Sign The Angry Moms’ Formal Response to FDA Public Docket Request

Please sign by July 19th, 2023.


The clozapine Risk Evaluation and Mitigation Strategy (REMS) surveillance platform experienced a disastrous failure on November 15th, 2021. Inherent flaws in the program were painfully exposed when a third-party vendor change likely shut down thousands of clozapine prescriptions. Patients got very ill, some were hospitalized, some patients never regained their health,(1) and there has been at least one documented death.(2)


Phone calls flooded the new REMS Call Center, yet the agency was unequipped to respond. Doctors, patients, caregivers, and pharmacists waited on hold for hours. Help requests went unanswered for days while patients ran out of their life-saving medication. Behind the scenes, dozens of lives were undoubtedly saved, and disasters were averted by families connecting on social media to send each other extra clozapine from their stockpiles.


Shockingly, the U.S. Food and Drug Administration (FDA) allowed this REMS program change to proceed with no validation, no verification of patient data, and little effort to ensure a safe continuum of care for clozapine patients.


Weeks later, on December 2, 2021, the FDA began various efforts to suspend the new REMS program by issuing poorly worded notices of “additional enforcement discretion.”(3) These announcements created more confusion and have inadvertently worsened clozapine dispensing restrictions. The nationally publicized death of Kevin Keith Langemeier on March 21st, 2023 is one such casualty.(4)


In the wake of the 11/15/21 disaster, the American Psychiatric Associate (APA) filed a Freedom of Information Act (FOIA) request to the FDA on March 3, 2022.(5) The request seeks information pertaining to lost patient data, how contracts are structured with clozapine manufacturers, who has authority to fix problems, who is responsible for overseeing the REMS administration, and how the FDA is assessing whether the REMS is even still necessary.


To our knowledge, the request for this information has gone unanswered.


The FDA’s lack of accountability and disregard for psychosis patients and their caregivers illustrates their ignorance. Regulators are oblivious, and painfully out-of-touch with the challenges faced by patients and families that live with treatment-resistant psychosis disorders.


In March 2023, the FDA opened a public docket requesting comments on “Changes to Third-party vendors for Risk Evaluation and Mitigation Strategies (REMS) programs.” The deadline for submissions is July 21, 2023.(6)


Administrators of The Angry Moms have created a formal response to this public docket request for comments. We are gathering signatures to be submitted with our response. Please click the link below and add your signature. Signatures collected via the online petition will be appended to the formal submission. Please forward this to family members and loved ones of individuals whose lives have been affected by the clozapine REMS.


Link to sign the The Angry Moms’ formal response:



Cited Sources:


(1) Schizophrenia & Psychosis Action Alliance, “Schizophrenia Externally-Led Patient Focused Drug Development Meeting” 2 Nov. 2022, (https://youtu.be/F9F3BiFsrhk)


(2) ACUTE CARE Volume 27, Issue 1, Medication Safety Alert! January 13, 2022. Institute for Safe Medication Practices (https://www.ismp.org/acute-care/medication-safety-alert-january-13-2022)


(3) U.S. Food and Drug Administration, “FDA is temporarily exercising enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine” 2 Nov. 2022, (https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program)


(4) Amarillo Globe-News, “Family of man killed in officer-involved shooting releases statement” 24 Mar. 2023, (https://www.amarillo.com/story/news/2023/03/24/family-of-man-killed-in-officer-involved-shooting-releases-statement/70046992007/)


(5) Moran M. APA Files FOIA Request With FDA Seeking Resolution to Clozapine REMS Problems. Psychiatric News. 2022 Apr; 57 (4)


(6) U.S. Food and Drug Administration, “Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies; Establishment of a Public Docket; Request for Comments” 23 Mar, 2023, (https://www.federalregister.gov/documents/2023/03/23/2023-05962/changes-to-third-party-vendors-for-risk-evaluation-and-mitigation-strategies-establishment-of-a)



2 ความคิดเห็น


Guest
13 ก.ค. 2566

Done.

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Guest
12 ก.ค. 2566

We have filed a federal lawsuit to stop the Clozapine REMS program with a court order. We have a GoFundMe page, 100% going to legal expenses. We need help from patients and families about the hideous impact on them by this FDA obstructionist Program. https://www.gofundme.com/manage/stop-fda-clozapine-rems-save-a-dozen-lives-a-day This is the lawsuit for any lawyers who want to support us. https://bit.ly/Behar-v-FDA

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