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 danger of extreme neutropenia, the FDA has decided that the clozapine REMS is now not essential, and by eliminating the REMS, they anticipate 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 scientific, 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 remedy for treatment-resistant schizophrenia. For too many, the obstacles weren’t simply scientific—they have been additionally logistical. The brand new academic initiatives from S&PAA and AAPP are essential to make sure this variation 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, advised Psychiatric Occasions.
“Navigating remedy for schizophrenia is extremely difficult. We’re thrilled to launch our first in a collection of academic packages to deal with and entry efficient care and remedy outcomes,” mentioned Gordon Lavigne, the S&PAA chief government 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, hostile results administration, particular populations, and affected person views.
- To mix scientific proof with real-world methods.
- To cut back stigma and enhance outcomes for individuals dwelling with severe psychological sickness.
“Clozapine is a life-saving medicine for these dwelling with schizophrenia, however many clinicians haven’t acquired coaching on this medicine nor managed and monitored sufferers on clozapine,” mentioned Michelle Geier, a psychiatric pharmacist and president of AAPP. “This curriculum providing on clozapine is a large step ahead in guaranteeing that well being care professionals have entry to the data wanted to save lots of and enhance affected person lives.”2
The FDA first introduced it didn’t “anticipate prescribers, pharmacies, and sufferers to take part within the danger analysis and mitigation methods (REMS) program for clozapine or to report outcomes of absolute neutrophil rely (ANC) blood checks earlier than pharmacies dispense clozapine,” again in February.4
References
1. Clozapine REMS. Accessed June 16, 2025. https://www.newclozapinerems.com/dwelling
2. S&PAA launches new training collection to take away obstacles to remedy & 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 Occasions. February 25, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine
