Drugs

Clozapine REMS Curbs Treatment: Comments

Three stakeholder organizations are asking FDA to revise the Risk Evaluation and Mitigation Strategy (REMS) for the psychiatric drug clozapine to reduce its barriers to treatment for many patients. In its comment for a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee, the American Academy of Child & Adolescent Psychiatry says that despite the drug’s efficacy, the REMS program “imposes substantial barriers that disproportionately affect young people, particularly those from marginalized or underserved communities. The stringent monitoring and logistical hurdles of the current REMS system make it difficult for young people and their families to access this potentially life-saving treatment.”

The letter says specific barriers include:

frequent lab monitoring;
pharmacy issues;
health system navigation;
impact of climate change and weather disruption/natural disasters; and
limited access to prescribers.

The letter makes seven recommendations for changes to the REMS.

In its response, the National Alliance on Mental Illness (NAMI), encourages FDA to remove barriers to care by allowing patients to have the choice to opt out of the REMS after the initial highest-risk period and to allow for emergency prescriptions when the administrative barriers are not met. “We believe these options would more appropriately allow patients, families, and providers to weigh the burdens of REMS and blood draws with the risks inherent to clozapine,” it says. NAMI says allowing patients to opt out would allow them to work with their doctor to understand and address the rare risk of infection that might result if they opt-out. “We also believe that adding a provision for emergency prescription when administrative hurdles are not met in a timely manner represents another essential way to let people make informed decisions with their doctors,” the response says.

The American Psychiatric Association comment letter recommends reducing the scope of the current REMS program to focus on education only.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome