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 : EC787
Submitter : Ms. Christina Zarrella Date & Time: 10/13/2005 08:10:42
Organization : Ms. Christina Zarrella
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?
An item can be available to a subpopulation over the counter and not require a prescription. Simply have the product available at the pharmacy and require ID to dispense it. (This would be similar to the purchase of diabetic needles at pharmacies and cigarettes in stores.)
B. If it could, would it be able to do so as practical matter and, if so, how?
See my response to A. Yes it can be practically achieved.
GENERAL
GENERAL
It appears that conservative politics are playing a role in the FDA's decision on this matter. Having access to safe, reliable birth control should be considered a human right.