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 : EC386
Submitter : Ms. Anita Jaynes Date & Time: 09/20/2005 04:09:33
Organization : U of Nebraska Medical Center
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?
No, this would not be enforceable. Therefore such a limitation should not be enacted.
I am a Certified Nurse-Midwife. I believe that Plan B should be available over the counter to consumers of all ages without restrictions. It is a safe medication and the FDA's only concern about its use should be safety. Plan B is much safer for women of all ages than pregnancy.