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 : EC912
Submitter : Mr. William Moses Date & Time: 10/18/2005 01:10:00
Organization : Mr. William Moses
Category : Individual Consumer
Issue Areas/Comments
1
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, it will not be possible to adequatly control the distribution of a prescription drug product to a specific sub-population if the same drug product is available over the counter.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
Yes, it will not be possible to adequatly control the distribution of a prescription drug product to a specific sub-population if the same drug product is available over the counter.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is certainly significant confusion in the general publics understanding of the FDA's interpretation. This is a decision that extends beyond the scope the FDA was and is intended to reach.
C. If so, would a rulemaking on this issue help dispet that confusion?
Regardless of weather a rulemaking would dispet the confusion, or the opposite, it should still take place. If for no other reason than to aknowladge the importance of this decision.
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?
As a matter of law, the FDA can regulate, not enforce.
B. If it could, would it be able to do so as practical matter and, if so, how?
Not only would the FDA be unable to enforce a limitation as a practicle matter, it would be impossable for anyone to do so. If a pregnant 15 year
old wants to obtain this drug without parental consent, she will certainly be able to do so if it is readaly available over the counter.
3
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 comment
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
GENERAL
GENERAL
I appreciate the opportunity to voice my oppinion. The bottom line is that if a product which is meant to be controlled in a specific sub-population is readily available as an over the counter product, there will be no effective control of that substance in the intended sub-population.