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 : EC1778
Submitter : Mrs. Lorraine Carreira Date & Time: 10/31/2005 03:10:07
Organization : Mrs. Lorraine Carreira
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?
see general comment below
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?
see general comment below
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
see general comment below
C. If so, would a rulemaking on this issue help dispet that confusion?
see general comment below
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?
see general comment below
B. If it could, would it be able to do so as practical matter and, if so, how?
see general comment below
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?
see general comment below
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
see general comment below
GENERAL
GENERAL
Please do not allow the Drug called "Plan B" to be sold over the counter. I feel that this is a very dangerous drug but also it has grave moral and ethical implications. The danger of abused women to be forced to abort exists, and also the danger of young girls getting access to this drug also exist. This is something that I don't agree with at all, I feel that this drug is a very bad idea. However, if it must exist, then PLEASE do not allow it to be sold over the counter. Thank you.