By Schizophrenia and Psychosis Action Alliance

Submitted by David E. Geiger, MEE, PE (ret.)

It’s official! The U.S. Food and Drug Administration has announced Nov. 19 for its joint advisory committee meeting to re-evaluate the clozapine REMS program, which has created significant access barriers for people with schizophrenia. The Drug Safety and Risk Management and Psychopharmacologic Drugs Advisory Committees will focus on “possible changes” to the REMS “to minimize burden on patients, pharmacies and prescribers while maintaining safe use of clozapine.” See initial meeting info here: https://bit.ly/4fHbJOY 

 

S&PAA has been working with the schizophrenia community to alert FDA and Congress to the dangers of the REMS program to people who rely on clozapine for their recovery and survival. (See the most recent letter here: https://bit.ly/4dz2XAP.) It has taken much work and many voices, but our campaign has successfully brought this issue to a head. 

 

The meeting will be webcast live and recorded for future viewing. S&PAA will provide more information, including the meeting agenda and link to the live webcast, once it’s available.