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 : EC805
Submitter : Mrs. Violet Corey Date & Time: 10/13/2005 08:10:20
Organization : Mrs. Violet Corey
Category : Individual Consumer
Issue Areas/Comments
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 believe that allowing Plan B to be sold over the counter would result in the drug being used by girls sixteen and younger without a doctor's supervision. It would be bought by older young women and given or resold to the younger ones. I believe it would be detrimental to the health of girls, and should not be done.
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?
B. If it could, would it be able to do so as practical matter and, if so, how?
Certainly not.
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?
That would be confusing even to those who are trying to obey the laws.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Under any circumstances.