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 : EC695
Submitter : Dr. Peter Colosi Date & Time: 10/12/2005 06:10:06
Organization : Franciscan Univ. Steubenville OH, Austrian Campus
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?
There is no way to regulate that youngsters not obtain anything sold on a shelf. It was easy for me to get beer when I was younger than 18; and it was exciting to succeed at it. When Viagra hit the market there was an explosion of sales and use, prostitution increased you may recall...the same explosion of purchase and use will occur here for all ages. And sales will soar because people will think this is a new cure-all (I bet the commercials have already been produced, they'll be similar to the viagra ones) and now it's right there on the shelf. Research indicates that surgical abortions will not decrease, and it seems that STD's will increase. Those who want you to put this on the shelf know that as soon as it occurs (they wouldn't care if you picked 30 years old as the boarder age, they just want it to be available w/o perscription) the sales will sky rocket. You may be able to tell from this comment, that I am not in favor of abortion, and therefore opposed to this pill as such; my point here, however, is to make the simple point that: young people will be hurt by this pill on a large scale, you will fail in any attempt to regulate this for any age, and the motive for the request you have been given is lust for money not concern for any age group.
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 should NOT be enacted that the same drug be both prescription and OTC.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
It's perfectly clear to me what you are considering.
C. If so, would a rulemaking on this issue help dispet that confusion?
There is no confusion, this manner of formulating the question is odd.
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?
Of course not, did you ever have someone buy alcohol for you before you were of age?
B. If it could, would it be able to do so as practical matter and, if so, how?
It is impossible, and as I mentioned above, those who have asked you for this dual set-up, perscription/OTC, for the same drug do not care what age you pick; there will be a surge of sales as soon as it becomes OTC.
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?
This is an unimportant question.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Again, I don't see the point this question. However, if you think that a different package will help somehow in the effort to keep this drug out of the hands of younger people, it won't.
GENERAL
GENERAL
Please see my answer to question 1