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 : EC947
Submitter : Dr. Ann Steiner Date & Time: 10/27/2005 08:10:35
Organization : Penn Health for Women
Category : Health Professional
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?
NO, the marketing of the drug should be held to the same standard other drugs are held to-which is according to safety. Drug should be available for all. Furthermore, recent studies show that in the case of Plan B, younger users are MORE responsible than older users
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?
no
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
GENERAL
GENERAL
I feel strongly that Plan B should be marketed OTC to all age groups. There is no increased risk to ANY age group, nor evidence of abuse of the drug for use for which it is intended according to age. If anything, its OTC use should be directed to younger consumers. This is not a place for politics. OTC availability of Plan B is totally appropriate.