This was a momentous week for the prevention of suicide and for the treatment of psychosis and related disorders. As one psychiatrist posted on LinkedIn, the end of the clozapine REMS represents “a historical reparation.”
The FDA’s announcement posted the morning of February 25th, 2025, to end the clozapine REMS was followed by tears of joy and disbelief within our community. We never thought we would see this day. We are grateful to the FDA for taking meaningful action, and for honoring their words that suffering patients and their families were heard at last.
Within hours, our celebrations turned into chaos. Some larger chain pharmacies have implemented requirements beyond the FDA’s REMS program requiring their staff to enter patients’ recent ANC values in their own internal system prior to dispensing clozapine. Some insurance plans which pay for prescription medications still require a REMS Dispense Authorization (RDA) code to pay for a clozapine pharmacy claim. The REMS agency did not immediately receive formal guidance from the FDA regarding their program operations.
Given these “business as usual” conditions, pharmacists spent this week unfairly “caught in the middle.” This is nothing new. For years pharmacists have faced threats of losing their jobs should they fail to honor the multiple layers of restrictions associated with dispensing clozapine. After the FDA’s announcement finally posted on the REMS website Friday morning February 28th, one of our members was refused clozapine by a CVS pharmacist who told them the “REMS system is down.”
The hectic conclusion of the clozapine REMS has confirmed what The Angry Moms have experienced: multiple agencies and unseen forces have engaged in a combined effort to make it very difficult to obtain clozapine.
By means of regulation, policy, and culture, these decades-long barriers to clozapine have contributed to suffering, loss and desperation for many. A generation of long-time clozapine patients have scars and buried veins after needlessly enduring decades of inappropriate monitoring with constant threats to their treatment plan over any misstep. Patients and families were ignored for years.
The Angry Moms have awakened to another great realization: our work is just beginning.
Psychiatrists are still tragically utilizing clozapine as a “last-line” treatment, with the misperception that safer, more “modern” alternatives exist. Providers need significant training on current best practices. The clozapine prescribing guidelines need an overhaul: the ANC monitoring “requirements” are outdated, and the fast titration schedule is outright dangerous.
The Angry Moms are now actively engaged in a global effort to improve access to clozapine and to correct errors and deficiencies in the clozapine product label. Every eligible person who stands to benefit from clozapine treatment deserves a skilled, competent, safe trial of clozapine with a slowed titration, appropriate monitoring, and responsible mitigation of side effects. This is our new mission.
In 1989, Sandoz Pharmaceuticals released Clozaril® for use in US markets. The product launch, championed by the Godfather of Clozapine, Dr. Gil Honigfeld, was accompanied by a branding campaign with the slogan, “Hope for a New Beginning.”
More than 35 years later, once again, we have Hope for a New Beginning.
The Angry Moms
As I've pointed out, it looks like the only solution to this nonsense is a class action lawsuit. Now it looks like we'll have to add insurance companies and clozapine manufacturers to the legal complaint. This is also why we must stand FIRMLY on eliminating monthly blood testing (for anyone on clozapine over 2 years) and not just eliminating REMS.