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 : EC840
Submitter : Mrs. Barbara Rew Date & Time: 10/13/2005 10:10:53
Organization : Home Health Care
Category : Health Professional
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
If it is available as otc you would loose control over the product and set yourself up for litigation, not to mention the physical harm it could cause to some, including the destruction of unborn children
1.
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?
I do not believe it is a good idea because a product is either safe to use w/o a RX or it is not. I question the motives of those who are pushing that a subpopulation have unregulated acess.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There has not been as far as products being marketed and/or used for two different purposes, however confusion will happen if you allow the same product to be marketed for the same purpose in two seperate ways.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes it would, the same product should not be either a RX or OTC if it is for the same purpose
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?
Yes it could
B. If it could, would it be able to do so as practical matter and, if so, how?
The same as they enforce tobacco sales to minors
3
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 don't believe that packageing has anything to do with this issue
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
your getting into trouble and opening a Pandora's Box if you even consider doing this
GENERAL
GENERAL
Plan B is intended to act as a an abortifacient. We are talking about innocent human life here. We are one nation under God. Remember that one day you shall meet Him face to face. Would you want to try and explain why you allowed the destruction of millions of tiny humans, His creation? Even in the temporal order it is an unwise effort to try and disturb the natural law. Use common sense and think about where this is going. This is not good medicine...this is murder.