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 : EC705
Submitter : Ms. Nancy Cariglio Date & Time: 10/12/2005 06:10:46
Organization : Ms. Nancy Cariglio
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 and they should remain with the ruling that drugs should not be marketed as both a prescription drug and an OTC drug. If it can be harmful to some, it should not be allowed as an OTC drug because it could and WILL fall into the wrong hands. There would be no real control.
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 and I do not believe they should be marketed both ways. An active ingredient that could prove harmful to underage persons should not be sold OTC.
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?
Yes.
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?
I don't believe they could control the enforcement.
B. If it could, would it be able to do so as practical matter and, if so, how?
Don't believe they could.
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?
Don't believe they should be sold in the same package either.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
N/A as I do not believe they should be sold in a single package.