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 : EC1792
Submitter : Mrs. Anastasia Brien Date & Time: 10/31/2005 03:10:32
Organization : Mrs. Anastasia Brien
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.
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?
NO.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No.
C. If so, would a rulemaking on this issue help dispet that confusion?
Make OTC contraception available to all.
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?
It is unfair to discriminate against those under 16. There should be no such 'subpopulation' restrictions.
B. If it could, would it be able to do so as practical matter and, if so, how?
Make the product available to all
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?
Like the rest of the developed world, the product should be available to all. You know it is safe and effective and your morality police have no say in our choices.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No circumstances are inappropriate
GENERAL
GENERAL
Make OTC contraception available to all.