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 : EC1863
Submitter : Mrs. Virginia Ralston Date & Time: 10/31/2005 03:10:25
Organization : Women's Political Caucus
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?
The FDA's job is to determine safety and efficacy, not to serve as the "morality police" on behalf of any special interest group.

1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
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?
no
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?
yes
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
none
GENERAL
GENERAL
Please APPROVE Plan B for over the counter sale!