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FDA Dysfunction: REMS

10/05/2018

Three years ago I reported that FDA refused to tell me what company administers the clozapine REMS (Risk Evaluation and Mitigation Strategy) program for the agency. Around that time I filed a Freedom of Information Act request for the information with the FDA. About 1 year later, when I inquired about the status of the request, the FDA representative told me it could take as long as 24 months to get the information to me. About 1 year ago I inquired again, and the representative told me that 210 requests were ahead of mine. Today, 3 years after the initial request, he told me that there are only 135 requests ahead of mine. 

Just now I placed another call to the clozapine Rems program. The representative there still refused to tell me who he works for but agreed to escalate the request. I'm not holding my breath.

Today I also accessed the FDA listing for the proprietary Ionsys brand of Fentanyl. The latest official label, listed as "REMS-Modified," generates a "page not found" error.

Is this just a coincidence? Is this information really free?

By the way, I discovered through my own detective work that the McKesson company administers the clozapine program, and Google answered my question as to what company manufactures the stealth bomber on the first try. So much for government secrecy.