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 : EC526
Submitter : Dr. Sharon Thompson Date & Time: 09/29/2005 06:09:10
Organization : Mt. Carmel St. Ann's Hospital
Category : Health Professional
Issue Areas/Comments
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?
It would not be possible to regulate having "prescription" status for a particular subpopulation because it would be too easy to circumvent this.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would need to be "behind the counter" in pharmacies, and pharmacists would need to regulate. However, even this seems like it would be easy to circumvent if something is a prescription item just for certain subpopulations. For any subpopulation that is a minor, I would think a signature of a legal guardian would be necessary.
I would hope the FDA would never sacrifice safety for convenience. It seems like there is quite a push for convenience over safety, and my hope is that the FDA won't cave to the pressure.