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 : EC405
Submitter : Mr. Vikram V Kulshrestha Date & Time: 09/20/2005 04:09:28
Organization : Amoli Organics Pvt. Limited, INDIA
Category : Drug Industry
Issue Areas/Comments
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?
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?
In my opinion, it will not be possible to ensure the misuse.
B. If it could, would it be able to do so as practical matter and, if so, how?
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?
It seems practically tricky to control the marketing of the same molecule for same indication in a single package as both prescription & OTC drug. In my personal opinion, a drug (molecule) can be sold as Prescription and OTC product with two different BRAND names. One brand can be marketed as a Prescription drug and the other one as the OTC, thus with two different Packaging.

But, the question is ?How the misuse of the same will be prevented by FDA, as the drug will be ultimately available to the subpopulation by a
different route ?

So, it is not preferable to market same molecule as both a Prescription and OTC product for same indication.

And it does not seem possible for FDA to enforce a check for limiting the sale of OTC product to a specific population even if the product is labeled for OTC and or Prescription.