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 : EC637
Submitter : Mrs. Natalie Rios Date & Time: 10/12/2005 06:10:54
Organization : Mrs. Natalie Rios
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?
Yes, I think it is very important to have consistent, specific, "codified" interpretations of all actions regarding when an active ingredient can be simultaneoulsy marketed in both prescription drug product and OTC drug product. This provides for no confusion to all parties concerned.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. There is too much room for a party to "interpret" this ruling in a way they find in support of an even opposing, unintended use for this particular drug.
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?
No way! No, think model airplane glue... the manufacturers of this product I believe never sat down to ponder that maybe their product, intended for model-building recreation would end up being the vechicle chosen by those under-age, and over age for that matter as not only a tool for recreation but for abuse and in many cases, suicide and accidental death. Make the ruling clear, with set rules and keep it out of the hands of those who might not be ready to contemplate the true, life-long consequences of such a personal decision.
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. It doesn't make sense to have it both presripction and OTC at the same time... why bother?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Selling these two products in a single package would NEVER be appropriate.