2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC193
Submitter : Mr. Robert Georgius Date & Time: 12/07/2005 06:12:14
Organization : Mr. Robert Georgius
Category : Individual Consumer
Issue Areas/Comments
Thank you for raising this issue. It mowst certainly needs to be reviewed and and the review could not be more timely.

For several years now drug companies have been using direct-to-consumer advertising to promote products that they claim relieve derpession, or offer a 'cure' for a myriad of other emotional or psychological difficutlies auch as Attention Defficit Disorder based on the idea that there is a 'chemical imbalance' in the brain that causes these disorders and that the drung being promoted will some how correct that imbalance.

This is false advertising and because of the nature and side effects of these drugs it is down right dangerous false advertising.

All ot the data I have seen or heard on this subject indicates that:
a) There is no scientific data that defines 'normal' brian chemistry.
b) There is no imperical evidence that people suffering from depression, or ADHD
have brain chemistry that is any different than that of people who do not
suffer from these problems.
c) There is no imperical evidence that the drug being pormoted changes brian
chemistry from what it was to a more normal 'chemical balance'.
In the ads in question these scientific facts are neatly avoided by stating 'May be caused by a chamical imbalance' rather than the declarative 'Is caused by a chemical imbalance' because the latter is obviously and patently false while the former holds out a hope for relief and appears to be scientifically based when it is not.

But the result is the same. False Advertising and it shoul not be tolerated. In fact it should be punished with some form of financial sanctiions and a required pulic appology that includes a statement these ads were false and intentionally misleading and any further ads not based on established scientific fact should be banned.

THese are dangerous drugs we are talking about here; with potentially tragic, even fatal side effects. Your agency has recently taken laudable steps to alert the public to these dangers with changes to lables, etc. In this light how can one justify allowing these drugs to be falsely advertised directly to consumers?
That's rhetorical by the way. THis advertising is indefensible and must be stopped.

Again, I aplaud you for looking into this issue and trust you will take effective action to handle this situation.


Robert H. Georgius