2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC753
Submitter : Mrs. Angela Funkhouser Date & Time: 10/13/2005 08:10:27
Organization : Mrs. Angela Funkhouser
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I think that this product is not being marketed both as a prescription drug product and an OTC product, per se. In reality, it is being marketed for different levels of restriction as is appropriate for various age levels. Similarly, society doesn't feel that a 14 or 15 year old can properly handle the responsibilities of driving alone so a 'permit' is issued. At 16, in most states, a license is issued because we feel that the 16 year old can handle the responsibility and is aware of the consequences of their actions. In this case at hand, an adult can be treated differently than a 16 year old and there is nothing wrong with placing further restrictions based upon age limits.