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 : EC567
Submitter : Mr. Dominic Colvert Date & Time: 10/12/2005 06:10:58
Organization : Mr. Dominic Colvert
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?
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?
To make the OTC distinction by age 16 years would make FDA the laughing stock of consumers. It would severly undermine the credibality of the agency. An unforcable rule is a bureaucratic excuse!
B. If it could, would it be able to do so as practical matter and, if so, how?
Common sense says no.