2005N-0345
FDA Comment Number : EC1542
Submitter : Ms. Margo Pellegrino Date & Time: 10/31/2005 09:10:01
Organization : my home
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?
only if it means Plan B (emergency contraception) will be available to the public without a perscription
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?
see above statement
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
apparently, as we still cannot get emergency contraception (Plan B) OTC....and 2006 is getting closer (contrary to you folks at the FDA--it is NOT 1880!)
C. If so, would a rulemaking on this issue help dispet that confusion?
only if you allow Plan B to be sold OTC
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?
You can buy cigarrettes without a perscription to a particular subpopulation (older than 18 inNJ), you can buy booze without a perscription to a particular subpopulation(older than 21), Rush Limbaugh abused oxycoton (sp) WITH perscriptions--I bet you can enforce whatever you want and still make Plan B available to the public withOUT a perscription!
B. If it could, would it be able to do so as practical matter and, if so, how?
Of course--boy you guys have to be a bunch of numbnuts if you can't--look at cigarrettes, booze, and firearms. Stop acting like a bunch of idiots---please!!! Next you'll be putting up references to "intelligent design" on your website!!!!!
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?
oh my god. You guys can really split hairs. Well, the damn thing has been split, drawn, and quatered, sauted up and eaten. Who gives a damn about packaging? Make it a small little blue box with a yellow smiley face already! If it makes you happy, put it in a different goddamn package!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
oh brother. It wouldn't ever be inappropriate to sell the stuff in a single package--how about that?
GENERAL
GENERAL
Please stop toying with women's lives. Make emergency contracetion - Plan B- available now. If I or my daughter were to be raped or realize-- woops, I wasn't protected and neither was he, you better believe I'd want that available to me or my daughter ASAP--hell hath no fury if I couldn't get that!