Feb 27, 2025
Arlington, VA — Today, the National Alliance on Mental Illness (NAMI) released the following statement from Chief Executive Officer Daniel H. Gillison, Jr., following the Food and Drug Administration (FDA) announcement on February 24 that they will remove burdensome requirements to access clozapine, a lifesaving antipsychotic medication. This announcement comes after a long advocacy push from NAMI and the mental health community and is a great step forward for lifesaving access to care, making it easier for people who will benefit from this medication to access it. Gillison said:
On February 24, the FDA issued a clarification, effective immediately, that would remove the burdensome Risk Evaluation and Mitigation Strategy (REMS) requirement for regular blood draws to monitor clozapine risks, recognizing that the benefits of clozapine outweigh the risk; instead, the REMS requirements created a burden on the providers and the health care system and, most importantly, made it hard for people to access and maintain this important treatment option.
The FDA’s action is in response to a multi-year advocacy effort from NAMI and advocates in the serious mental illness community who shared their lived experiences and argued that the current REMS process was overly burdensome and limited access to lifesaving care for people who rely on clozapine. Dr. Ken Duckworth, NAMI’s chief medical officer, submitted comments and testified to the FDA on the importance of clozapine in November 2024. Of the FDA’s decision, Dr. Duckworth said:
NAMI recognizes that successful treatment looks different for different people with mental illness. We will continue to advocate for people with mental illness to have access to a broad range of medication and treatments that work, and help people live fulfilling lives.
