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 : EC609
Submitter : Mr. Daniel Billingsley Date & Time: 10/12/2005 06:10:44
Organization : Mr. Daniel Billingsley
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?
I do not believe that products should be offered in OTC as well as prescription because of the confusion this would cause as to use and dose.
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?
I do not believe that products should be offered in OTC as well as prescription because of the confusion this would cause as to use and dose.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I believe there is a lot of confusion.
C. If so, would a rulemaking on this issue help dispet that confusion?
I don't believe a new rulemaking on confusing rule would help. I just believe if a product is safe enough to OTC then a prescription should not be required.
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?
The enforcement would not fall to the FDA, it would fall on the entity selling the product.
B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA could not enforce this limitation.
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?
What would be the distinction in product? Would this not cause more confusion?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I don't believe the two products could be sold or packaged in a single package.