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Secrets of REMS

03/31/2016

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.