2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC11
Submitter : Dr. Tim Shannon Date & Time: 11/18/2005 02:11:36
Organization : Dr. Tim Shannon
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Hi,
I'm very concerned that the FDA is not doing its job. Specifically the science is simply not conclusive at all regarding a link between brain chemical imbalances and the action of drugs. Of course, the main culprit here is antidepressants. Pharmaceutical companies are touting that there are problems with serotonin and depression that is absolutly not proven - it is conjecture at best. Yet the FDA still allows the DTC advertisments to use wording that is not accurate. This is wrong and misleading. The FDA needs to take a stand and support advertising that is viable - not hype.
2005N-0354-EC11-Attach-1.PDF