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 : EC663
Submitter : Mr. Anthony Hunter Date & Time: 10/12/2005 06:10:59
Organization : Mr. Anthony Hunter
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?
Absolutely. This is especially true when we have the issues of drug marketing. Clarifiyng this rule can help clarify the way drugs are marketed to consumers
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. This would be necessary to prevent claims of unfairness in the decision making about how drugs are made available
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 do not think that there can be. Just as it is difficult to stop under age purchases of alcohol and tobacco, medications that are limited by age will be sold over the counter to those who are below the required age. With the number of fake identifications that are availiable, it is naive to think that a rule can limit the age of people who purchase medicens over the counter
B. If it could, would it be able to do so as practical matter and, if so, how?
There is no way that the FDA can successfully enforce this.
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?
I do not think so. Having the same packaging will make it entirely too dificult to determine the differances.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If you have prescription and over the counter sales, they should not be in the same package.