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 : EC696
Submitter : Mrs. Judith A. Croxton Date & Time: 10/12/2005 06:10:20
Organization : Mrs. Judith A. Croxton
Category : Individual Consumer
Issue Areas/Comments
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?
This is a dangerous drug to begin with - and has killed women who have taken it. I am against it being prescribed at all and especially against selling it over the counter to anyone. This drug takes the life of a tiny human being in most cases. All contraceptive products do is increase promiscuity among our young people and put them at risk for at least one of the several sexual diseases out there now. You might just as well say their life is over once they have these diseases - and many of them will never be able to have any children at all;all because they were led to believe that becoming pregnant would be the worst thing that could ever happen to them ! As a mother of 13 children and the grandmother of 19 (at present), I feel it is inhumane and monstrous for the drug companies to put any ingredients on the market for killing human life - born or unborn - whether it is marketed by prescription or sold over the counter. I say the drug companies should get out of the "killing" business and stick to the "healing" business, don't you??

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?
Who is considered "sub-population" ????

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
These products, and all others like them, should be "out-lawed" !
Not realizing this had so many sections in which to comment, please see my comments at the very beginning of this inquiry. Thank you.