Advocacy Group Applaud Joint FDA Committee Proposed Changes to Clozapine REMS Requirements

Gordon Lavigne, CEO, Schizophrenia & Psychosis Action Alliance

“This is an incredibly hopeful moment for our community and validates what effective advocacy can do when voices come together with collective action,” Gordon Lavigne, MEd, told Psychiatric Times in an inclusive interview. Lavigne, chief executive officer for the Schizophrenia & Psychosis Action Alliance, spoke about the pivotal US Food and Drug Administration joint advisory committee meeting that reviewed the Risk Evaluation and Mitigation Strategies (REMS) requirements for clozapine, the sole FDA-approved treatment for treatment-resistant schizophrenia. The proposed changes aim to remove longstanding barriers to accessing this life-saving medication, which have negatively impacted patients and families for years, he explained.

Clozapine, while highly effective for treatment-resistant schizophrenia, has faced stringent REMS protocols designed to monitor severe neutropenia, a relatively rare side effect, he said. However, these measures have created widespread challenges, including limited pharmacy access, excessive documentation requirements, and delays in medication refills.

"The clozapine REMS system that has been in place for years has created a number of significant treatment access barriers that have caused unnecessary burden and suffering for individuals all across the country," said Lavigne.

The advisory committee's recommendations included eliminating the requirement for prescribers to document absolute neutrophil count (ANC) results within the REMS system and for pharmacies to verify these results before dispensing Clozapine. Additionally, the committee suggested ending the need for health care provider certifications through the REMS system.1,2 If adopted, these changes could significantly reduce bureaucratic delays faced by patients, Lavigne said.

“The committee members concluded that the REMS had resulted in an excessive focus on neutropenia,” Lavigne said. “Their consensus was that no barrier to treatment is worth interrupting treatment with clozapine.”

Despite the promising recommendations, the FDA is not obligated to implement the proposed changes, leaving the final decision uncertain, he added. If the FDA follows the committees’ recommendations, could remove the “unnecessary burdensome barriers that the clozapine REMs has put in place, granting access this vulnerable patient population.

The meeting marked the culmination of years of advocacy efforts, including a 2022 patient-focused development meeting hosted by the Schizophrenia & Psychosis Action Alliance, which highlighted the real-world impacts of REMS on patients and families. “This was an opportunity for the entire community of allied organizations, patients, and their families to come together to elevate and amplify the voices of those living with schizophrenia," Lavigne said.

“We're hopeful the FDA will act sooner than later, because every minute matters for a medication that is the only FDA-approved option for people with treatment-resistant schizophrenia—and has been approved with an indication for suicide ideation. There are no other options for this community, and we are waiting every day for the final recommendation.”

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References

1. Duerr HA, FDA Committees Vote to Dismiss Clozapine REMS. Psychiatric Times. November 20, 2024. Accessed November 25, 2024. https://www.psychiatrictimes.com/view/fda-committees-vote-to-dismiss-clozapine-rems

2. FDA Advisory Committee Meeting Clozapine Risk Evaluation and Mitigation Strategy. November 19, 2024. Accessed November 20, 2024. https://www.fda.gov/media/183655/download