The Food and Drug Administration (FDA) announced that it has eliminated the clozapine risk evaluation and mitigation strategies (REMS) program, effective Feb. 24. The move followed an FDA advisory committee’s November 2024 recommendation to discontinue the REMS.
ASHP joined the American Association of Psychiatric Pharmacists (AAPP) and other healthcare groups in requesting the agency change or eliminate the clozapine REMS program. ASHP also connected members with FDA staff to provide the agency with a frontline picture of how the REMS impacted patient care.
“We applaud FDA’s elimination of the clozapine REMS program, which will remove a significant barrier to appropriate patient care,” said Tom Kraus, ASHP vice president of government relations. “The engagement and advocacy of ASHP members and their colleagues persuaded FDA to discontinue an overly restrictive REMS program that threatened patient access and complicated patient care.”
ASHP congratulates AAPP for its successful leadership on this advocacy effort. Questions or concerns about changes to the clozapine REMS, or about REMS programs generally, should be sent to Jillanne Schulte Wall, senior director of health and regulatory policy.
