Email HHS To Improve Clozapine Access by July 5th, 2026
- 2 days ago
- 10 min read
The Angry Moms Need Your Help.
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Help Modernize Clozapine Access in America
The U.S. Department of Health and Human Services (HHS) is accepting public comments through July 5 as part of the Great American Recovery Initiative. HHS is specifically seeking recommendations to improve mental illness treatment, reduce barriers to care, strengthen the behavioral health workforce, reduce stigma, and modernize healthcare using existing funding.
This is our opportunity to tell HHS how clozapine changed our lives—and what barriers still prevent people from receiving it.
We Need Your Story!
Please write a short email (300–600 words) describing your family's experience.
These do not need to be perfectly or expertly written – just share your story!
Your personal story is far more powerful than statistics.
HOW TO WRITE YOUR EMAIL
The “To” Email Box:
The "CC" Email Box:
The "BCC" Email Box (Optional)
If you'd like to share your responses with us, please blind copy The Angry Moms administrator on your email to HHS. If we are contacted with questions, we will have your stories available to reference.
Email Subject:
Great American Recovery Initiative – Family Comment on Clozapine
THE INTRO:
Dear Secretary Kennedy,
My name is __________, and I am [example: the mother of an adult son living with schizophrenia]
“WHAT HAPPENED & HOW TO FIX IT” SECTION
Choose one or more topics from the "Clozapine Topics & Asks" list below and tell your story. Keep it short; just 1-2 paragraphs. Follow up with “The Angry Moms Ask” – you can even copy and paste the “ask” provided!
EMAIL ENDING (Copy and Paste if you’d like!)
I support efforts to modernize the FDA clozapine label and remove unnecessary barriers that prevent people with serious illnesses from receiving the most effective medication available. Please consider the recommendations submitted by The Angry Moms as you develop the Great American Recovery Initiative.
Respectfully,
[First and Last Name]
[Title - example: Mother and Family Caregiver]
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Thank you for helping improve access to clozapine for families across the country. Below are the suggested topics and “asks,” followed by a few example emails in case you need inspiration to get started.
Let's Do This!
The Angry Moms
CLOZAPINE TOPICS & “ASKS”
Delayed Access to Clozapine
Examples: Years of failed medication trials before clozapine was finally offered; repeated psychiatric hospitalizations, suicide attempts, homelessness, incarceration, violence, or permanent loss of functioning while waiting to qualify for clozapine; providers reluctant to prescribe it because of outdated safety concerns; or inability to find a clinician knowledgeable about clozapine. Many individuals experience years of unnecessary suffering, while families lose critical opportunities for recovery because clozapine is offered only as a last resort.
The Angry Moms Ask: Please modernize national treatment guidelines to encourage timely, individualized, evidence-based use of clozapine for schizophrenia spectrum disorders and illnesses involving psychosis when clinically appropriate. Patients should not be required to fail years of treatment, experience repeated hospitalizations, or lose irreplaceable years of recovery before being offered the most effective antipsychotic medication available.
Agency-Created "Shadow REMS" Programs
Examples: Clinics, pharmacies, or health systems continue to impose REMS-like restrictions that exceed current FDA recommendations. These include requiring patients to return multiple times each month for separate laboratory draws and medication pick-up, withholding prescriptions until laboratory results are reviewed despite no clinical concerns, dispensing only one- or two-week supplies of medication, refusing emergency refills, interrupting treatment because of missed appointments or delayed laboratory testing, or requiring unnecessary office visits before medication can be dispensed. Many patients are forced to ration medication or experience avoidable treatment interruptions even though the FDA eliminated the Clozapine REMS program.
The Angry Moms Ask: Please require the FDA to issue clear national guidance prohibiting unnecessary "Shadow REMS" policies that create barriers beyond evidence-based practice. Clozapine programs should prioritize continuity of treatment by allowing clinically appropriate medication supplies, same-day laboratory review whenever possible, point-of-care finger-stick ANC testing, streamlined prescribing workflows, reasonable emergency medication supplies, and individualized monitoring plans that prevent unnecessary treatment interruptions.
Blood Testing Barriers
Repeated venous blood draws; unsuccessful blood draws because of poor or "buried" veins; repeated trips to laboratories or clinics only to be turned away because of insurance, staffing, or scheduling problems; long travel distances and hours-long waits for laboratory testing; aggressive or severely symptomatic patients creating safety concerns during blood collection; repeated medication interruptions, emergency discontinuations, or pill rationing because laboratory testing became an administrative barrier rather than a clinical necessity.
The Angry Moms Ask: Please direct the FDA to modernize the FDA-approved clozapine prescribing information to support flexible ANC monitoring, including finger-stick testing, clinically appropriate alternatives when laboratory testing becomes a barrier, and, when necessary, symptom-based monitoring with informed consent similar to the approach used for other medications with rare hematologic risks, such as methimazole, to avoid unnecessary interruption of lifesaving treatment. Monitoring should be individualized based on clinical risk and designed to maximize both patient safety and continuity of treatment.
Clozapine Dosing and Side Effects
Examples: Extreme sleepiness, dizziness or fainting when standing up, severe body aches or flu-like symptoms, rapid heartbeat, severe constipation, pneumonia, seizures, concerns about heart inflammation, symptoms of neuroleptic malignant syndrome (NMS), medication started too quickly, or providers unfamiliar with slowing or individualizing clozapine dosing when side effects occur.
The Angry Moms Ask: Update the FDA clozapine label to reflect current evidence supporting individualized titration based on patient-specific factors, with slower dose escalation and early dose adjustments when clinically indicated to improve safety, tolerability, and long-term treatment success.
Treatment Interruptions
Examples: Clozapine unnecessarily discontinued during hospitalization, incarceration, transfer between hospitals or treatment programs, admission to emergency departments, pharmacy or insurance delays, missed laboratory testing, provider unfamiliarity with clozapine, or medication interruption simply because the receiving facility lacks clozapine expertise, refuses to continue treatment, or cannot promptly verify prescribing or laboratory information.
The Angry Moms Ask: Please direct HHS to promote continuity of clozapine treatment across all care settings by developing national best practices that minimize unnecessary treatment interruptions during hospitalizations, incarceration, transfers of care, pharmacy transitions, and insurance changes. Clozapine should not be discontinued for administrative reasons when continuation is medically appropriate, and every effort should be made to ensure uninterrupted access during transitions of care.
Finger-Stick ANC Testing
Examples: Patients refusing or delaying clozapine because of fear of repeated venous blood draws; treatment interrupted because of poor or "buried" veins, transportation barriers, or inability to access laboratory services; patients requiring more frequent ANC monitoring after low counts who would otherwise be forced to discontinue clozapine because repeated venipuncture is no longer practical; and families paying thousands of dollars out of pocket because finger-stick devices and testing supplies are not routinely covered by insurance. Finger-stick ANC testing dramatically reduces the burden of monitoring, improves adherence, and makes clozapine possible for many patients who would otherwise never start or continue treatment.
The Angry Moms Ask: Please direct HHS and the FDA to promote finger-stick point-of-care ANC testing as a standard monitoring option for clozapine by incorporating it into the FDA-approved prescribing information, encouraging payer coverage, establishing clear reimbursement and billing pathways, and supporting implementation across hospitals, outpatient clinics, ACT teams, correctional settings, mobile treatment programs, and home-based care. No patient should be denied access to clozapine because routine laboratory monitoring is unavailable, unaffordable, or impractical.
Clozapine Workforce Education and Clinical Competency
Examples: Providers unfamiliar with individualized titration, therapeutic drug monitoring, management of common side effects, cross-titration from previous antipsychotics, recognition of inflammation-related increases in clozapine levels, proactive management of tachycardia, constipation, weight gain, and metabolic complications, or safe use of adjunctive medications. Patients may experience avoidable side effects, treatment interruptions, unnecessary discontinuation, inappropriate dose adjustments, preventable hospitalizations, or premature abandonment of clozapine because clinicians lack confidence or specialized training. A poor initial clozapine experience can permanently discourage patients and families from ever trying the medication again.
The Angry Moms Ask: Please expand national clozapine education and competency programs for psychiatrists, psychiatric nurse practitioners, pharmacists, primary care clinicians, emergency departments, hospitalists, correctional healthcare providers, and other clinicians involved in clozapine care. Training should emphasize individualized titration, therapeutic drug monitoring, management of common side effects, continuity of treatment, cross-titration strategies, metabolic health, recognition of inflammation and drug interactions, proactive bowel management, and shared decision-making to maximize patient safety, tolerability, and long-term treatment success.
SAMPLE EMAIL SUBMISSIONS
Subject: Great American Recovery Initiative – Family Comment on Clozapine
Dear Secretary Kennedy,
My name is Deborah, and I am the mother of my adult son, Nick, who lives with schizophrenia.
Clozapine gave me my son back.
Before clozapine, our lives were filled with psychiatric hospitalizations, fear, and crises. When Nick is not taking his medication, his illness quickly takes over. He has become aggressive during past episodes of psychosis, and I have been hurt trying to keep him and others safe. Every interruption puts him at risk of losing everything he has worked so hard to regain.
Even though the FDA ended the Clozapine REMS program, our community clinic continues to operate what feels like its own version of REMS. Nick is only given a seven-day supply of medication at a time. His refill is held until his blood test results are received and reviewed.
Every single week we worry that something will go wrong. If the laboratory is delayed, if the clinic is busy, if there is a paperwork problem, or if anything falls through the cracks, Nick could miss doses of the one medication that keeps him well. We live with that fear every week.
No family should have to wonder whether an administrative delay is going to send their loved one back into psychosis. Clozapine is not just another prescription. For my son, it is the difference between living safely at home and being hospitalized. It is the difference between stability and crisis. It is truly a life-and-death medication.
Please direct the FDA to modernize the clozapine prescribing information and make it clear that unnecessary "Shadow REMS" programs should not stand in the way of treatment. Patients should not have their medication interrupted because of rigid local policies. Monitoring should protect patients, not create barriers that place them at risk.
Thank you for listening to families like mine. I hope no other mother has to live every week wondering if a delayed blood test or a clinic policy will take away the medication that saved her child's life.
Respectfully,
Deborah Jones
Mother and Family Caregiver
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Subject: Great American Recovery Initiative – Family Comment on Clozapine
Dear Secretary Kennedy,
My name is Marisa, and I am the mother of my daughter, Blythe, who lives with schizophrenia.
By the time Blythe was finally offered clozapine, it felt like our last hope. We had been through years of failed medications, hospitalizations, and heartbreak. We believed we had finally reached the treatment that could give her a chance at recovery.
Instead, the way clozapine was started nearly destroyed that chance.
While Blythe was hospitalized, her doctors followed the standard hospital titration schedule and increased her clozapine to 300 mg in just two weeks. Almost immediately she became extremely ill. She was so sleepy she could barely stay awake. She dropped things because she couldn't hold onto them. She collapsed when she tried to walk. She couldn't get out of bed. She had repeated episodes of vomiting, and after only two weeks she developed pneumonia and had to be rushed to the emergency room.
Our family was devastated.
Instead of questioning whether the medication had been increased too quickly for Blythe, she was labeled "clozapine intolerant," and our last hope was taken away.
Later, her case was reviewed by a clozapine specialist. We were told that because of Blythe's ancestry and poor-metabolizer status, she should have been receiving about 100 mg after two weeks, not 300 mg. What happened was not that clozapine failed my daughter. It was that my daughter was treated using a one-size-fits-all dosing schedule instead of an individualized approach.
Today, Blythe is terrified of clozapine. She remembers how sick she became. Every time the medication is mentioned, she remembers collapsing, vomiting, and waking up in the emergency room. I cannot help but wonder what her life would look like today if her treatment had been individualized from the beginning.
Please direct the FDA to modernize the clozapine prescribing information to reflect current scientific evidence on individualized titration and dosing. Patients differ dramatically in how they metabolize clozapine because of factors such as ancestry, sex, smoking status, obesity, inflammation, and interacting medications. No family should lose its best opportunity for recovery because outdated dosing recommendations sabotage a patient's first experience with the most effective medication available.
Thank you for considering our family's story and for helping ensure that other patients are given a fair chance to succeed on clozapine.
Respectfully,
Marisa Lopez
Mother and Family Caregiver
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Subject: Great American Recovery Initiative – Family Comment on Clozapine
Dear Secretary Kennedy,
My name is Rodney, and I am the father of my 13-year-old son, Jamal. Jamal has severe autism with aggressive behaviors. Before clozapine, our family lived in constant crisis. He was hurting himself, hurting others, and every day felt like a battle just to keep him safe.
Clozapine changed our lives. For the first time in years, our home became peaceful. Jamal smiles more. He is calmer. We have happy days together that we never thought were possible. Clozapine has truly been a miracle for our son.
The hardest part isn't the medication. It's the blood tests. Getting Jamal into the car is often a struggle. Sitting in a laboratory waiting room is overwhelming for him. We have had to physically restrain him just to obtain a blood sample. Every blood draw is traumatic for Jamal and heartbreaking for us as parents.
Our only realistic option was an FDA-cleared finger-stick ANC testing device that allows us to monitor his blood counts with a simple finger stick instead of repeated venous blood draws. Unfortunately, our insurance would not cover it.
We have spent thousands of dollars out of our own pockets to purchase the device and continue buying the testing supplies because we simply could not risk losing the medication that gave our son his life back.
If health insurance routinely covers glucose meters and testing supplies for people with diabetes, families like mine should not have to pay out of pocket for medically necessary finger-stick ANC monitoring that allows children and adults to remain safely on clozapine.
Please direct HHS to expand insurance coverage and establish clear reimbursement pathways for FDA-cleared finger-stick ANC testing for patients receiving clozapine. No family should be denied access to lifesaving treatment because the safest and least traumatic monitoring option is considered unaffordable.
Thank you for listening to our family's story and for helping children like Jamal continue receiving the medication that has given them a chance at a safer and happier life.
Respectfully,
Rodney Williams
Father and Family Caregiver
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