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 : EC648
Submitter : Mrs. Darlene Lerche Date & Time: 10/12/2005 06:10:15
Organization : Mrs. Darlene Lerche
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 would prefer that this product not be available to anyone over the counter or by prescription. If everyone is dead set on making it available over the counter, then it certainly SHOULD NOT BE AVAILABLE over the counter to young people, who are too young to understand all the implications of taking the pill. Also, it may be harmful to them if they take it unsupervised.
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?
We limit minors from buying alcohol and cigarettes by punishing people who sell them these products. People purchasing these items must show ID to the clerk to prove they are old enough. Why wouldn't it work the same for this drug?
B. If it could, would it be able to do so as practical matter and, if so, how?
See above.