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 : EC712
Submitter : Mrs. Kathleen J. den Breejen Date & Time: 10/12/2005 06:10:27
Organization : Mrs. Kathleen J. den Breejen
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?
Absolutely not.
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. You cannot do things two ways.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, it would not.
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?
It would be very difficult. Young girls will just older ones to buy the drug and then use it. Can't you see this?
B. If it could, would it be able to do so as practical matter and, if so, how?
No.
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 would be strange. It makes no sense.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If you charged differently for each one.
GENERAL
GENERAL
Regarding the morning-after pill, it should not be dispensed at all. It only discourages responsibility for one's actions. In this case, we are playing with lives and that is dangerous.
Instead, we should be encouraging our teens to be productive citizens. They should be busy with schoolwork, some sports and some form of community service in which they help others. This goes for males, as well as females.