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 : EC2169
Submitter : Dr. Deborah Thorp Date & Time: 10/31/2005 06:10:01
Organization : Dr. Deborah Thorp
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?
Yes
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
Depends on the rule
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?
Products (alcohol, tobacco) are routinely sold only to adults now. This is no different.
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?
Can't think of any.
GENERAL
GENERAL
There is no rational reason not to sell Plan B over the counter. It is safer than current OTC medications, such as some of the anti-histamines and non-steroidal pain medication.