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 : EC693
Submitter : Mr. Sidney Baker Date & Time: 10/12/2005 06:10:49
Organization : Mr. Sidney Baker
Category : Drug Industry
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?
Yes. Seventeen year olds are still children and harmful if not seriously damaging drugs should not be provided to them over the counter.
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?
YES.
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?
Yes.
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.
B. If it could, would it be able to do so as practical matter and, if so, how?
Have the druggists themselves refuse to sell the product. Fine them if experince shows they did not do so.
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?
When the prospective purchasers are over 21.
GENERAL
GENERAL
Government's dtuty is to protect the life and well being of the nation's children.