Drug Information Update- FDA working with manufacturers to resolve challenges with the Clozapine REMS Program

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS Program, including technical issues with the website, data migration problems, and long call wait times since the launch of the program on October 12, 2015. We understand this has caused frustration and take these concerns seriously. We are working closely with the Clozapine REMS program administrators to address the challenges, many of which are a result of merging data from six registries encompassing more than 50,000 prescribers, 28,000 pharmacies, and 90,000 patient records.

During this transition to the new shared Clozapine REMS program, continuity of care, patient access to clozapine, and patient safety are our highest priorities. Healthcare 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. Prescribers and pharmacies should continue to work with the Clozapine REMS Program to resolve any issues.

FDA has asked the Clozapine REMS Program administrators to continue posting updated information and to help answer frequently asked questions under the “Important Program Update” section of the Clozapine REMS Program homepage.

Prescribers and pharmacists who encounter issues with the Clozapine REMS Program should contact the Clozapine REMS Contact Center at 1-844-267-8678; Monday – Friday, 8am – 10pm EST. Because of the challenges mentioned above, the Contact Center has been extremely busy. However, the Clozapine REMS program administrators have informed FDA that wait times are improving. We encourage pharmacists and prescribers to continue their efforts to complete certification and update patient information to meet the requirements of the program.

If you have questions or concerns about the Clozapine REMS Program or its website please contact FDA atdruginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400. We appreciate your continued support.

For more information please visit: Clozapine REMS