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 : EC112
Submitter : Mrs. Michelle Combs, RN Date & Time: 09/20/2005 11:09:17
Organization : Infectious Diseases Assoc. of Fort Lauderdale
Category : Health Professional
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?
No comment
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
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 doubt it.
B. If it could, would it be able to do so as practical matter and, if so, how?
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?
It would help to eliminate confusion if it was packaged seperately.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No comment
Allowing age to be a defining factor in OTC vs. perscription of Plan B is absurd! Grocery and drug store clerks who are paid minimum wage will not remember to ID for this particular drug. I feel that it should be offered as a prescirption drug only. The young women that would be trying to obtain this pill as an OTC, if made available OTC, are the very ones who need medical attention.