Friday, November 20, 2015

FDA Extends Deadlines for Clozapine REMS Program

The Food and Drug Administration (FDA) is extending deadlines for provider and pharmacy certification for participation in the Clozapine Risk Evaluation and Mitigation Strategy (REMS).

In an announcement issued this week, the FDA said it is indefinitely extending the deadlines due to technical and other problems associated with the Clozapine REMS. New deadlines will be issued after further evaluation by the administration. “We are also carefully evaluating next steps regarding the December 14, 2015, pre-dispense authorization (PDA) launch,” the FDA said in a statement. “We will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible.”

The Clozapine REMS Program replaces the individual clozapine patient registries that had been required previously for monitoring neutrophil counts in patients receiving the antipsychotic, which has been associated with a risk for agranulocytosis. The new REMS program was initiated this year in an effort to ease burdens on clinicians and pharmacies and to make clozapine—one of the most effective antipsychotics and the only drug approved for treatment-resistant schizophrenia—accessible to more patients.

The administration said the deadlines are being extended to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. “Health care providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators,” the administration said. “Prescribers and pharmacies should continue to work with the Clozapine REMS Program administrators to resolve any issues and continue their efforts to complete certification and update patient information to meet the requirements of the program.”

APA is continuing to discuss concerns related to implementation of the Clozapine REMS program with the FDA. For information on the Clozapine REMS, click here. For further information in Psychiatric News, see “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?”


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