Raymond C. Love, PharmD, BCPP, FASHP, CPNP President
Over the past 6 months, CPNP has led a response regarding the Clozapine REMS on behalf of its membership. We have successfully raised a number of issues of concern about the REMS Program and took the following actions:
CPNP was recently invited to join the FDA Network of Experts which just this month involved CPNP assisting with the identification of experts to advise on specific aspects of clozapine administration. This invitation recognizes the fact that we have become a more visible resource within the FDA.
As you know, the REMS Program has made many significant changes based on our input, but we continue to hear concerns about:
We remind you of the FDA’s message to us is that the medical needs of patients are a priority that should not be negatively impacted by the REMS program. We will continue to advocate for necessary changes to the Clozapine REMS Program addressing the issues above and additional issues as they arise. Please keep us apprised of the additional challenges that the REMS Programs presents by emailing firstname.lastname@example.org or by communicating via the CPNP list at email@example.com.