2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC373
Submitter : Mr. Joseph Wisdom Date & Time: 12/12/2005 02:12:59
Organization : Mr. Joseph Wisdom
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
To the FDA:

I would like to raise a point which has come up in my own mind personally regarding the advertisements of psychiatric/psychotropic drugs. This point comes up because I understand how strict guidelines are for FDA approval of advertising medicines and so forth.
There are commercials regarding psychiatric/psychotropic drugs which state that such drugs help cure "the chemical imbalance in the brain" and that such drugs are safe, using the typical "fast and quiet" disclaimers.
First of all, there isn't a psychiatrist or doctor anywhere who even knows what the proper chemical balance in the brain is. Furthermore, they don't even have a scientific method or test to diagnose a chemical imbalance in the first place. Secondly, the FDA has placed Black Box warning labels on such of these various drugs. It is CRITICAL the public clearly gets this distinction communicated as it is, not with the pretense of anything in the way of "safe".
I can understand these issue you face in this area.
However, it is your responsibility to ensure such false advertising ceases immediately. These are more than simply "fudging" the product's worth. These are outright lies which tend to misinform the public of the danger these drugs can pose.
Sincerely,
Joe Wisdom
jcw1686@yahoo.com