On June 13, 2025, the US Meals and Drug Administration (FDA) formally eradicated the clozapine REMS, and all REMS operations ceased.1
Though clozapine nonetheless carries a threat of extreme neutropenia, the FDA has decided that the clozapine REMS is not obligatory, and by eliminating the REMS, they count on to enhance entry to clozapine. Notably, the FDA nonetheless recommends monitoring sufferers’ ANC and details about extreme neutropenia stays within the prescribing data for all clozapine medicines. From right here on out, dedication of the appropriateness of clozapine for a affected person stays solely with the prescriber.
Within the wake of this choice, the Schizophrenia & Psychosis Motion Alliance (S&PAA), in collaboration with the American Affiliation of Psychiatric Pharmacists (AAPP), has introduced the upcoming growth of “A New Period in Clozapine Administration,” which is a set of medical, evidence-based programs designed to supply training and steerage for clozapine prescribing. The revocation of bloodwork monitoring and different administrative necessities is a direct results of S&PAA’s advocacy.2
“Eliminating the REMS for clozapine is greater than a regulatory shift—it’s a second of hope for sufferers and households who’ve waited too lengthy for entry to the best therapy for treatment-resistant schizophrenia. For too many, the obstacles weren’t simply medical—they had been additionally logistical. The brand new academic initiatives from S&PAA and AAPP are essential to make sure this transformation reaches the affected person. With out swift, sensible steerage for prescribers, sufferers might nonetheless be left behind. We owe it to them to fulfill this second with motion,” mentioned Chad Koyanagi, MD, a member of the S&PAA Board of Administrators and medical director of the Disaster Continuum and Medicaid Providers within the Hawaii Division of Well being’s Grownup Psychological Well being Division, instructed Psychiatric Instances.
“Navigating therapy for schizophrenia is extremely difficult. We’re thrilled to launch our first in a collection of academic applications to handle and entry efficient care and therapy outcomes,” mentioned Gordon Lavigne, the S&PAA chief govt officer.2
“A New Period in Clozapine Administration” will launch within the fall. This academic collection will endeavor to fulfill a number of targets3:
- To assist clinicians confidently and safely prescribe clozapine for treatment-resistant schizophrenia.
- To supply coaching on initiation, monitoring, antagonistic results administration, particular populations, and affected person views.
- To mix medical proof with real-world methods.
- To cut back stigma and enhance outcomes for folks dwelling with severe psychological sickness.
“Clozapine is a life-saving remedy for these dwelling with schizophrenia, however many clinicians haven’t obtained coaching on this remedy nor managed and monitored sufferers on clozapine,” mentioned Michelle Geier, a psychiatric pharmacist and president of AAPP. “This curriculum providing on clozapine is a big step ahead in making certain that well being care professionals have entry to the knowledge wanted to avoid wasting and enhance affected person lives.”2
The FDA first introduced it didn’t “count on prescribers, pharmacies, and sufferers to take part within the threat analysis and mitigation methods (REMS) program for clozapine or to report outcomes of absolute neutrophil depend (ANC) blood assessments earlier than pharmacies dispense clozapine,” again in February.4
References
1. Clozapine REMS. Accessed June 16, 2025. https://www.newclozapinerems.com/residence
2. S&PAA launches new training collection to take away obstacles to therapy & restoration. Information launch. June 16, 2025. https://www.einpresswire.com/article/822059272/s-paa-launches-new-education-series-to-remove-barriers-to-treatment-recovery
3. Supplier coaching. Schizophrenia & Psychosis Motion Alliance. Accessed June 16, 2025. https://sczaction.org/provider-training/
4. Duerr HA. FDA formally removes REMS requirement for clozapine. Psychiatric Instances. February 25, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine