Clozapine REMS Program Saga: Are They Gonna Change Their Ways?

Dr. Jim Amos Scary TieSo yesterday I sent the message to the FDA about my frustration with the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program. Today I got a reply–from an unnamed Drug Information Specialist who said,

We apologize that you are continuing to experience technical difficulties.  Please be advised we have requested that the Clozapine REMS Program Managers contact you directly for assistance.

I was not contacted by any Clozapine REMS Program Managers, whoever they are. On the plus side, at around 1:00 PM or so today a REMS representative did call me–not to solve my problem once and for all, mind you, but to take information from me so that my issue can be “escalated,” evidently meaning prioritized and expedited to the next level in the bureaucracy.

But the main thing is–it’s progress!

On the other hand, the representative could not give me an idea of when my problem certifying would be addressed. I did give her an earful of my opinion about the Clozapine REMS Program, although I thanked her for her time and assured her I was not blaming her. I did tell her I think the Clozapine REMS Program Managers should be held accountable for this apocalyptic failure of a program which has been billed as the answer to the monitoring difficulties for managing Clozapine.

Who are these Clozapine REMS Program Managers, anyway? Hmmm…

Anyway, I gave the rep a clue that, should anyone from their program try to reach me at my office by phone again, they should try between 8 AM and 5 PM, because they’ve called me when I’m not available–twice.

And, I gave the rep my rant. It didn’t do any good to tell her things like I faxed all they needed to enroll me on the first day the program rolled out, October 12, 2015. She didn’t know anything about that.

I just have to wait and see if they’re gonna change their evil ways.

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