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 : EC624
Submitter : Mrs. Natalie Frey Date & Time: 10/12/2005 06:10:35
Organization : Mrs. Natalie Frey
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 should NOT be available over the counter - EVER. I would like it not to available at all.
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?
YES
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no
C. If so, would a rulemaking on this issue help dispet that confusion?
No
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?
Yes
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?
NO
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It is inappropriate all the way around. It is taking a life. What has happened to this world that it no longer matters when people kill unborn babies and is talked about in a matter of fact way? All the pharmaceutical companies care about is the almighty dollar. Shame on them.
GENERAL
GENERAL
I strongly oppose this drug.