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 : EC869
Submitter : Miss. Jennifer Wilbois Date & Time: 10/17/2005 10:10:11
Organization : Miss. Jennifer Wilbois
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?
yes
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
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
B. If it could, would it be able to do so as practical matter and, if so, how?
yes, just sell like cigarettes or alchol from behind a counter and see individuals IDs
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?
why not?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
none
GENERAL
GENERAL
Even the American Academy of Pediatrics approves for this to be sold OTC - so what is the hold up? As of right now you are denying women access to an important health advancement with no scientific backing for doing so!! Stop playing politics with our lives and our choices and make Plan B OTC!!