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 : EC1076
Submitter : Mr. Robert Quinlan Date & Time: 10/27/2005 10:10:03
Organization : Mr. Robert Quinlan
Category : Individual Consumer
Issue Areas/Comments
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?
I beleive it could enforce such a limitation.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't think it would be practical to enforce such a limitation.
GENERAL
GENERAL
Due to the nature of the drug, I believe it is one that should require a prescription so as to preserve the integrity of the parents rights and duties in caring for their children. Since this drug can act as an aborting agent on a conception, the parents have the right to have such a drug restricted from the availability of their child who may not have the capacity to make a mature judgement on such a decision. The gravity of the choice should not be left to the whim of a sales clerk as to whether to allow someone to purchase it or not as regardless of the enforcement that would be striven for, that is who we would be placing the decision in the hands of.