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 : EC691
Submitter : Mr. Thomas Carter Date & Time: 10/12/2005 06:10:31
Organization : Mr. Thomas Carter
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?
I am not sure what the interpretation is. I will say that I support OTC status. Short of that, I support a dual OTC/prescription status.
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?
I am not sure what the difference between "act" and "action" is - may I suggest including some background in "plain english" for those of us who are interested laymen, but not lawyers? Otherwise, see my answer for the first question.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes - I am not even sure what it is!!
C. If so, would a rulemaking on this issue help dispet that confusion?
It would seem so, although I do not know what the ramifications of such a rulemaking would be.
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?
Yes, I believe so.
B. If it could, would it be able to do so as practical matter and, if so, how?
I assume the "subpopulation" would be legal minors, under the age of 16-18. The limitation could be enforced by having undercover "minors" attempt to purchase the product OTC. Such practices are engaged in voluntarily by some retailers, e.g. Wal Mart IDs purchases of spray paint and alertness aids.
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 question is a little beyond my knowledge, but on the face of it, I believe so.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If it is determined that a special package, i.e. instructions designed to be easily understood and targeted to minors, is needed for the prescription package.
GENERAL
GENERAL
Once again, I believe that per the original recommedation, this drug should have been given OTC status. Short of that, I would support a dual OTC/prescription status.