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 : EC766
Submitter : Ms. Ellen Lukas Date & Time: 10/13/2005 08:10:53
Organization : none
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?
Yes.
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. For example, cigarettes and alcoholic beverages by law cannot be sold to the subpopulation under 18.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes. See answer above.
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?
It makes no sense to market the same active ingredients in both a prescription and OTC product.
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 circumstances.
GENERAL
GENERAL
The use of birth control and other possibly abortifacient products is a serious matter. OTC sales of the product called, in a trivializing, facetious and playful way, as 'Plan B', represents a major change in US social policy and will have a huge impact on adolescents' lives. Any such change should be made only with the approval of the legislatures in all 50 states.