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 : EC675
Submitter : Dr. Catherine Shoemaker Date & Time: 10/12/2005 06:10:37
Organization : Dr. Catherine Shoemaker
Category : Health Professional
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
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
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, there is not significant confusion over the FDA's current interpretation of the act. There are drug manufacturers who value money more than people's lives. They want the FDA to CHANGE its interpretation so they can increase sales, regardless of the effects of their products on people's lives.

It is ridiculous to have the exact same product, with the same drug concentration and indications, labeled for both prescription and OTC sales based on the age of the purchaser. If the use of the product requires professional supervision at all, it requires supervision at any age.
C. If so, would a rulemaking on this issue help dispet that confusion?
See "B" above
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?
Yes. Tobacco products are regulated in essentially this way.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not be possible, as a practical matter, to enforce such a limitation.

Such a law is already in place for tobacco products and they are still readily available to, and reularly used by, those too young to purchase them.

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. It is the same, not a different product. Packaging does not change its use or its effects.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It is inappropriate to sell this product. It has no medically necessary application whatsoever.