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 : EC2142
Submitter : Mrs. Consuelo Goldman Date & Time: 10/31/2005 06:10:28
Organization : Mrs. Consuelo Goldman
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?
not sure
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes
C. If so, would a rulemaking on this issue help dispet that confusion?
probably
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?
It should not be legal to make a drup available to only certain groups of people.
B. If it could, would it be able to do so as practical matter and, if so, how?
No, it would be very difficult to enforce.
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?
Should be sold in different packages
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Can't think of any
GENERAL
GENERAL
Emergency contraception should be available over the counter. The FDA has been delaying and stonewalling all efforts to make emergency contraception easier to obtain, to the detriment of women's health and personal rights. Keep religion out of politics, and protect the rights of all women!