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 : EC724
Submitter : Mrs. Mary Roybal Date & Time: 10/12/2005 06:10:26
Organization : Mrs. Mary Roybal
Category : Individual Consumer
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Apparently so!
C. If so, would a rulemaking on this issue help dispet that confusion?
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. We can't even keep cigarettes and alcohol from being sold and/or given to minors.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. There is nothing to stop an older friend/sexual partner/MOLESTER from obtaining the product for minors.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
I think packaging makes very little difference...
It is already reprehensible that the morning after pill is being sold as a prescription, let alone over the counter. "Emergency contraception" is a euphamism for what this chemical does, i.e. causes abortion, prevents an already independent living human being from obtaining the oxygen and nutrients it needs to continue living. This poison should be unavailable to ANYONE of ANY AGE at ANY TIME!!