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 : EC1565
Submitter : Dr. Yvonne Yao Date & Time: 10/31/2005 11:10:41
Organization : Dr. Yvonne Yao
Category : Health Professional
Issue Areas/Comments
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?
Although I believe that OTC access to all age groups would benefit the individual as well as society, I also see that age limited access is used in the sale of other products e.g. tobacco and alcohol. Therefore it seems that regulation by law would be possible as it has for these other products.
B. If it could, would it be able to do so as practical matter and, if so, how?
It could be handled like alcohol and tobacco, but perhaps by the pharmacist instead of the general retail clerk. For patients 18 or older, a picture id would allow purchase; for patients under 18, a prescription would be required. (Those without photo id might prefer to get a prescription from their doctors.)
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?
As long as the product is the same, it seems more "truthful" to package it in the same manner. It avoids the impression that one product is better or stronger.
Although it is possible to sell this product differentially to different types of patients, given that the product is safe and effective in younger as well older women, it would be preferable to sell it to all women over the counter to reduce barriers to access.
Younger woman are perhaps more likely to require confidentiality and also are more likely to be intimidated by the need to speak to a person of authority.