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 : EC1148
Submitter : Mrs. Connie Roulett Date & Time: 10/27/2005 02:10:52
Organization : Respect Life
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
No
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No
C. If so, would a rulemaking on this issue help dispet that confusion?
No
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
I really do not know.
B. If it could, would it be able to do so as practical matter and, if so, how?
Hard to pass judgement on this.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
NO
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There were be too much confusion to the consumer.
GENERAL
GENERAL
I am clearly against marketing any type of product either with a subcription or without. This will not curb or reduce the behavior of minors in taking responsibility for an active sex life without the appropriate financial, sexual, spiritual nor psychological maturity needed to support a birth of a child. Education on behaviors that are dangerous and risky to underage children which continue to promote new generations being raised in the circle of poverty is critical.