Clozapine REMS Program Debacle: FDA Finally Admits Problems

So  I just got a message today from the American Psychiatric Association (APA) that they are in contact with the FDA about the hysterically dysfunctional Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program.

APA Takes Action on Problems with Clozapine REMS

FDA“Last month, the FDA announced that beginning on October 12, all prescribers of clozapine—a medication used for the treatment of schizophrenia—are required to be certified in a Clozapine REMS (Risk Evaluation and Mitigation Strategy) Program. This change was part of an effort to improve the monitoring and management of patients taking the medication. Since the program’s launch, however, APA members have reported numerous technical, personnel, and process problems that they say could affect the appropriate prescribing and dispensing of clozapine.

Several challenges with the FDA’s Clozapine REMS rollout have been reported, including the following:

* Technical issues related to website operation and certification.
* Intermittent or nonexistent access to customer service representatives.
* Issues related to a certified prescriber’s ability to cover for or designate others to prescribe clozapine such as psychiatric residents.
* Unnecessary registration burdens that could create potentially harmful delays in the initiation or discontinuation of clozapine treatment.

In response, the FDA recently released an alert stating that prescribers and pharmacists should continue clozapine prescribing and dispensing, using their clinical judgment to consider the best interests of the patient even if they encounter problems with the Clozapine REMS certification program.

APA has been in contact with the FDA to share its clinical concerns and has agreed to collaborate to effect an appropriate implementation of the clozapine REMS. APA will also continue to gather information from its district branch and state association executives as well as the APA councils on Research and Quality Care.

To read more about the issues around clozapine, see the Psychiatric News article “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?””

I sent a message to the FDA email address in the alert to which a link is given above:

I would like to lodge a complaint about the new Clozapine REMS Program which launched October 12, 2015. I have been unable to certify as a prescriber since then and I can assure you that the technical difficulties associated with the web site and the problems with contacting any person to resolve them by telephone have been ongoing since October 16, 2015, the date on which the problems were allegedly resolved.

It has been over two weeks now and I still don’t know who to contact who would be in a position to address this issue.

I tried the phone number but there was no relevant “option” from the long list to choose which would allow me to leave a message or to talk with a real person. Someone who is an authority needs to investigate this problem because, while it’s true some people are getting through this spectacular failure to communicate, others like me are stymied by the impenetrable telephone instructions and the circular website technical snafus. The longer this goes on the more suspicious we’ll become of both the FDA and whoever is in charge of the Clozapine REMS Program; all we know so far is that they are the “clozapine manufacturers.”

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