A long and determined advocacy effort has reached the summit: The Food and Drug Administration (FDA) announced that it will no longer expect prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine. This includes the requirement that prescribers report results of absolute neutrophil count blood tests before pharmacies can dispense clozapine.
“Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk,” the announcement said. “FDA has notified the manufacturers that the clozapine REMS must be eliminated.”
The announcement follows a November 2024 meeting of the FDA’s Clozapine REMS advisory committee, which voted 14-1 to eliminate key provisions of the REMS after prescribers and patient advocacy groups, including APA, testified that the REMS creates significant administrative and logistical burdens for prescribers and pharmacies, sometimes causing life-threatening treatment interruptions for patients.
The FDA still recommends that prescribers monitor patients’ neutrophil count according to the frequencies described in the prescribing information. Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing boxed warnings.
In response to the announcement, Robert Cotes, M.D., professor of psychiatry at Emory University and director of the clinical and research program for psychosis at Grady Health System, told Psychiatric News, “The FDA’s decision to end the Clozapine REMS marks an important step in improving access to this life-saving medication.”
Cotes has been a longtime champion for wider access to clozapine. “I am especially grateful to all the patients and families who shared their stories at the FDA advisory committee meeting, whose voices and advocacy were instrumental in driving this important change,” he said. “While this is a huge milestone, we still have much more work to do to ensure that clozapine is used appropriately and widely enough to help all those who need it.”
The FDA said that in the coming months, the administration will work with clozapine manufacturers to update the prescribing information and eliminate the Clozapine REMS. Look for further coverage in Psychiatric News.
For related information, see the Psychiatric News article “Patient Advocacy Groups Demand Significant Changes to Clozapine REMS” and “‘Godfather of Clozapine’ Calls for End to REMS.”
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