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 : EC485
Submitter : Dr. Corrine Donley Date & Time: 09/27/2005 08:09:12
Organization : Behavior Analyst/Consultant Prviate
Category : Health Professional
Issue Areas/Comments
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?
Dear FDA,
I am strongly in support of the morning after pill be available to women over the counter. There are no side-effects that would preclude
this action.
Thank you Dr. Donley
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?
An age limitation for teenagers or younger would not be an efficient use of our tax dollars and certainly not worth the trouble and time.
B. If it could, would it be able to do so as practical matter and, if so, how?
This is really not possible without a great cost of money and time.
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 can not see why the package would need to be different.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There should be no circumstances for the inappropriate dispensing of this product.