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 : EC873
Submitter : Mrs. Mary Barrett Date & Time: 10/17/2005 10:10:52
Organization : Mrs. Mary Barrett
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?
OTC status of any drug puts the responsibility of its usage in the hands of the consumer who is not educated on the risks or consequences of using the drug. Today, irresponsible individuals are forced to see their physicians for physicals before receiving prescriptions. OTC removes that precursor putting the individual and the general public at risk for increase in disease as well as other medical issues that could be caught in the routine exam.
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?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No
C. If so, would a rulemaking on this issue help dispet that confusion?
No
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?
No
There is no way that the FDA would be able to enforce a plan like this. The subpopulation would find a way to evade the prescription and the product would become a blackmarket product allowing one segment of the population to take advantage of the subpopulation.
B. If it could, would it be able to do so as practical matter and, if so, how?
No
Again, you create a whole new blackmarket.
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
I cannot think of any circumstance that adds value to the general public. I can see a new segment of legalized feeding off illiterate or desparate individuals and/or situations.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See A