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 : EC603
Submitter : Ms. Estelle padawer Date & Time: 10/12/2005 06:10:12
Organization : Ms. Estelle padawer
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?
Hardly
B. If it could, would it be able to do so as practical matter and, if so, how?
HARDLY PRACTICAL
GENERAL
GENERAL
If there are no medical contra-indications for use by younger girls, Plan B should be available over the counter for ALL ages. This would be better than waiting to have an abortion.
Sadly we now know that incest is not rare; the victims need all the help we can give them.