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 : EC741
Submitter : Mrs. Tracey Pinque Date & Time: 10/13/2005 08:10:42
Organization : none
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?
There should not be a gray area in terms of prescription or OTC drugs. It needs to be either one or the other. If you allow this item to be sold over the counter you can not study the effect it has on a certain group. Whereas if you keep this a prescription then you can do an accurate study on the long term effects it has - whether it be positive or negative. You NEED to do what's in the best interest of the public, not for the business trying to market both ends. Also, if you put this drug as OTC, who is even going to see their doctor for a prescription? What side effects does this drug pose? You have a moral obligation to do what is in the best interest of the people, may God guide you in your decisions.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
C. If so, would a rulemaking on this issue help dispet that confusion?
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?
See my answer to the first question. Everything is there.
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?
NO. Again, refer to my answer in question #1.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?