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 : EC633
Submitter : Mrs. Allison Joyce Date & Time: 10/12/2005 06:10:32
Organization : Consumer
Category : Consumer Group
Issue Areas/Comments
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I am most concerned about the potential complications/dangers to the life and well being of consumers of this product to see it sold "over the counter." There is no way you could regulate that kind of sale. From the research I have read and the problems that are potential, I think it needs to be sold by prescription ONLY, so there would be the safety of a doctor's consult to hopefully prevent danger to the patient consumer. "Convenience" is a poor criteria when the life of the patient might be at stake.
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 see why not. There are all sorts of drugs that are only allowed to be sold by prescription.
3
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
NEVER