The Secret of REMS

A year after the clozapine REMS launch debacle I wrote about here, here, and here, I can report little progress in getting the FDA to divulge information about the program. What do they hope to hide? 

Both the program and an FDA pharmacist (Sola) have promised to send “sponsor assessments” required by FDA as stipulated in this document. I will not hold my breath.

I have made numerous attempts at contacting McKesson’s REMS division and their Vice President Heather Morel, but none has generated a response.

I discovered a document from the FDA Inspector General critical of REMS as lacking evidence of benefit.

Assuming that FDA has contracted with McKesson I filed another Freedom of Information Act demand for copies of any written agreements or contracts.

Stay tuned.

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