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Secrets of REMS
Both the FDA and the manufacturers continue to resolutely guard information about this program since I wrote last Fall about The Clozapine REMS Debacle. My Congressman, Adam Smith, failed to provide answers as did FDA lawyer Sarah Horowitz (Sarah.Horowitz@fda.hhs.gov). When I called to inquire about progress of my FOIA (Freedom of Information Act) request, the civil servant told me it could take 2 years to figure out who at FDA deals with this program.
Since that last post I learned by reading the Web site privacy statement that the program also goes by the name Clozapine Product Manufacturer’s Group, but a Web search turns up only one relevant hit: that same privacy statement. I posed questions to representatives of the various manufacturers:
What kind of business entity is ClozapineREMS?
Is it more than just a Web site?
What is the name of the manager of the program?
Is this entity licensed in a state?
In what state is it located?
How is the program funded, i.e. who pays the employees?
What is the name and contact information of any and all responsible FDA or DEA workers who supervise or liaison with the program?
What is the annual budget of the program?
So far I have discovered that McKesson operates some aspect of the program out of Arizona.
The program motto, “No Blood, No Drug,” sports a superscript “TM” designation, but I found no evidence of application for a trademark.
This absence of transparency raises serious questions about accountability and government, or maybe I just do not measure up as an investigative journalist.
If you can find answers to any of these questions, please comment below.