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 : EC872
Submitter : Mr. Eric Koretz Date & Time: 10/17/2005 10:10:33
Organization : Mr. Eric Koretz
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?
This is religious and partisan political bullshit. It is so obvious form the wording of Lesters statement that he is using the right wing republican religious views in holding back the over the counter release of this helpfull drug. Its amazing that you can sham the american public and get away with it. But times are changing, and you people and your power will fall. Religion has no place in politics and your moral values are bullshit.
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?
Pass the drug as an over the counter.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only confusion is by the FDA and how they think the bullshit they're spewing will trick the american public.
C. If so, would a rulemaking on this issue help dispet that confusion?
This form is bullshit to. How many of the american public who would use the drug wouild even understand how to voice their opinion on this matter through interpreting your wording and forms. Its amazing how evil and corrupt you people are. I'm sure you see yourself and your egocentric religious ideas as "in the right." But you people arent even human.
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?
Do you mean black people?
B. If it could, would it be able to do so as practical matter and, if so, how?
Do you have confederate flags in your homes above your mantel?
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?
You could sell them with condoms and i'm sure Trojan would cut the FDA in on a percentage of profits.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When they've been opened or if they pass the experation date.
GENERAL
GENERAL
You guys are bastards.