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[e-drug] Re: Undone postmarketing studies

E-drug: Re: Undone postmarketing studies

Dr. Wolfe:  I read your letter to Dr. Henney, and your report located on 
your web site.  I noticed that in the last paragraph of the report, you 
indicated a strong need to evaluate the financial requirements for 
enforcement of policies related to Phase IV compliance, yet did not include 
that in your request to Dr. Henney.

I also noted a lack of "solution" to the problems raised to the Director of 
the FDA, in both your letter to Dr. Henney, and your report.  Isn't it time 
to face the facts, and recognize that there are obvious, low-cost solutions 
to the present FDA approval process, and that these solutions can, in fact, 
raise the profit margins for the industry while lowering the cost of med  
icines to patients?

I would be pleased and honored to have your respected advice and 
suggestions on how to formally place the solution offered in front of you, 
the Public, and the regulatory agencies, i.e., the FDA.

Respectfully, Thomas A. Poe, M.D.

Thomas A. Poe, M.D., Director
The World Center For Clinical Research
2044 Plumas Street Reno, NV 89509-3708
Phone: 775-829-1799
admin@worldccr.org   http://worldccr.org

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