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 : EC730
Submitter : Mrs. Arlene Hamm Date & Time: 10/13/2005 08:10:28
Organization : Mrs. Arlene Hamm
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 need to do so.
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 need to do so.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There should not be.
C. If so, would a rulemaking on this issue help dispet that confusion?
No--the ruling is clear. The debate causes the confusion.
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?
No
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not.
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?
This should not happen at all.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
In all circumstances.
GENERAL
GENERAL
FDA is to be commended for studying this matter with great care. Its present ruling should be followed--16 is not a magic age for making a decision about this dangerous drug which will increase promiscuity and disease. Best it be banned altogether.