In November 2021, the Food and Drug Administration (FDA) instituted a new Clozapine Risk Evaluation and Mitigation Strategy (REMS) to monitor prescribing and dispensing of the drug, which is used to treat schizophrenia. The new REMS led to confusion for manufacturers, pharmacies, prescribers, and patients. Some clinicians stopped prescribing the already underutilized drug, and some pharmacies stopped dispensing it. This chaotic situation led the FDA to stop enforcing certain requirements of the REM for 90 days.

The American Psychiatric Association has been raising concerns over the November REMS alongside pharmacists, prescribers and patients, and continues to advocate for its safe and timely dispensation to patients who need it.

Background

The Clozapine REMS is a safety program required by the FDA to manage the risk of severe neutropenia associated with clozapine treatment and was originally instituted in September 2015. The REMS applies to all clozapine medicines on the market and requires the use of a centralized system to monitor patients and prevent or manage clozapine-induced neutropenia. REMS is administered by the Clozapine Product Manufacturers Group (CPMG).

Some of the problems associated with the November REMS stem from the fact that CPMG employed a new vendor to operate its website. Wholesalers, pharmacies, and prescribers have experienced multiple problems with the website, confusion about the new requirements, and difficulty resolving problems or getting questions answered in a timely manner. The original REMS database containing patient data was not transferred to the new vendor, resulting in clinicians and pharmacists not being able to look at past doses etc. Ultimately, the changes to the REMS resulted in unnecessary disruptions to patient care. In the case of those receiving clozapine, this disruption could prove to be life-threatening.

What APA is Doing

APA was active before the REMS was implemented and has been working since implementation to ensure patients can access Clozapine. Among the recent actions the APA has taken:

• Nov. 19, Dec. 2, and Dec. 16: Held hearing sessions with the FDA to raise concerns about the status of implementation.
• Jan. 27: Sent a letter to key House and Senate Committees regarding the issue. View letters here.
• Feb. 3.: During an FDA hearing, a member of the House Energy and Commerce Committee raised a concern about the Clozapine RES. View the recording of the livestream here.
• Feb. 14: Led a coalition letter to the FDA with six other organizations and received a response three days later.
• March 3: Filed a Freedom of Information Act request with the FDA to determine the relationship between the FDA and the CPMG and to determine how the vendor operating the online system was selected and how they handled the complaints. When it has more information, APA will make recommendations to Congress and FDA based on what it finds.

Stay up to date on APA’s activities on Clozapine REMs here.