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 : EC597
Submitter : Mrs. Deborah Thieme Date & Time: 10/12/2005 06:10:34
Organization : Mrs. Deborah Thieme
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?
yes
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?
Can't see how.
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?
I can't speak to the legality, but it would certainly be confusing.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
any and all
GENERAL
GENERAL
This product should not even be considered to be sold OTC. You cannot make pharmacists into policemen. On what basis was the arbitrary age limit decided upon? This will open up a huge can of worms. Some 13 year olds are physically more mature than some 16 year olds.

I know you are trying to address this narrow issue right now but I am vehemently opposed to this drug being sold in this country at all. It is not safe, it does not promote health, but disease. I don't know what studies you used, but you obviously had to ignore many others to reach the conclusions you did. In the old days when the FDA was more careful, most Americans felt you could be trusted, but now you rush things to market way too quickly, and more people are coming to believe that you have the best interests of the drug companies in mind more than that of the people. It looks like it's all about money rather than health. Shame!