Wow! This is an amazing step in dismantling the #REMS based barriers for people with serious mental illness to get the care they deserve with #clozapine. We couldn't be prouder to have our medical director, Dr. Robert Laitman, at the podium here. Listening to the stories of the families and individuals who have been harmed by these barriers for too long was truly heart wrenching. We are thrilled to see their heroic advocacy was not in vain.
?????? A joint FDA Advisory Committee voted today that the burdensome REMS blood-testing requirements for #clozapine are not needed for safe use of the medicine – saying that “the bigger issue is undertreated #schizophrenia.” While the committee’s decision still must be approved by FDA, it is an enormous victory for people with schizophrenia – many of whom have suffered severe relapses and even death after they were refused their medicine due to the #REMS. Committee members and even #FDA staff said the rallying cry from our community made them sit up and take notice. “The testimony was very moving and certainly moved me,” one member said. An FDA staff member added, “What you shared today will have an impact on regulatory decision making.” S&PAA has played a leadership role in amplifying the concerns of our community to FDA, and today was proof that we CAN make a difference. A huge THANK YOU to everyone who participated in this effort – especially to those living with this disease, whose compelling stories of both struggle and recovery made a powerful impact. S&PAA Board Member Dr. Rob Laitman testified that his son “is living a meaningful life” thanks to clozapine. Today’s vote brings us a giant step closer to making that possible for many.?