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 : EC1325
Submitter : Mr. John Loveland Date & Time: 10/28/2005 03:10:45
Organization : Mr. John Loveland
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?
Yes - it should be able to be bothYes
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I'm confused now. Why don't you make this simple and clear if you really want public input? And I have a degree in English. I imagine most comments you get are from people with professional agendas, hence, not worth much. Your spelling and/or typos and lack of clarity are disturbing.
C. If so, would a rulemaking on this issue help dispet that confusion?
Don't know
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?
Sure. You do it with tobacco, alcohol, weapons, farm chemicals, etc. No system is perfect. But who, after all, would want to buy OTC emergency contraception who doesn't need it? Me? I'm a man. All you are leaving out are a few poor girls, underage perhaps, who need it the most. So, if they cheat. In fact, don't limit it at all.
B. If it could, would it be able to do so as practical matter and, if so, how?
As practical as the above mentioned. It beats coat hangers and quack doctors that I remember in the 60's.
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I can't think of any. Just skip the prescription part all together. You think we are stupid and ignorant. Not.
Stop messing around and just pass Plan B, Emergency Contraception as an over the counter drug. Let women make their own decisions. Let them do things right and legally. Stop making excuses to drag your feet so this does not get passed.