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 : EC926
Submitter : Mr. Joseph Freeman Date & Time: 10/27/2005 08:10:15
Organization : University of Illinois College of Pharmacy
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?
Yes, The FDA is obligated to make a ruling on this in order to allow the product to be approved or denied.
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?
Yes, The FDA is obligated to make a ruling on this in order to allow the product to be approved or denied.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is confusion on the interpretation of the act.
C. If so, would a rulemaking on this issue help dispet that confusion?
A rulemaking would help clarify the confusion on the matter.
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?
If FDA limited sale of an OTC product to a particular subpopulation, the FDA would be able to enforce limitation as a matter of law.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be able to as a practical matter by holding individuals responsible for providing the drug to the limited sub population.
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 they may be sold in the same package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would innapropriate under no circumstances to do so.
GENERAL
GENERAL
As a current PharmD candidate and future pharmacist, I believe a ruling should be made and the product should be approved, with out political bias, based on the solid evidence of its efficacy and safety.