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 : EC612
Submitter : Dr. Peter Connaughton Date & Time: 10/12/2005 06:10:23
Organization : Michian State Medical Society
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?
Plan B should NOT be available as an OTC drug
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?
Make clear that Plan B cannot be available OTC
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
It is very clear to me. If it is not clear to others then a new rule clarifying not to use Plan B should be written
C. If so, would a rulemaking on this issue help dispet that confusion?
Make a clearer rule if that is what it takes to prevent Plan B from being sold OTC
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
B. If it could, would it be able to do so as practical matter and, if so, how?
Just enforce the law
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?
NO
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
All circumstances
GENERAL
GENERAL
Plan B must be stopped in its use withour a prescription