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.