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 : EC757
Submitter : Mrs. Sharon Nixon-Escochea Date & Time: 10/13/2005 08:10:06
Organization : Salt & Light
Category : Individual Consumer
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?
While I believe that abortion, in any form, is infanticide, I especially disagree with the fact that a 16 year old "minor" can obtain this product, through prescription, without the knowledge of a parent. They are not only unsupervised by a medical professional, but any parential supervision at all. We've all heard the stories of minors who have died alone @ home after using this pill. Could they have lived if someone were aware of what was happening? Quite possibly. Or, maybe they would have chosen other options if they had someone to clearly talk this all over with. Choosing life is not a bad option and there is less long-term guilt involved in giving a child up for adoption than murdering it. This is a proven fact.
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?
It's basically all the same...an unsupervised medicine which can cause this much potential harm should not be prescribed to a minor (or adult for that matter) who will more than likely be alone when facing the consequences (pain, abortion of the fetus, excessive bleeding, etc.)
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?
No and why regulate to one "subpopulation" more than another? This sounds like selected annihilation. It still has the same reprecussions and consequences.
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?
Again, legal mumbo jumbo. Same body - just a different coat.