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 : EC782
Submitter : Dr. Dale Michels Date & Time: 10/13/2005 08:10:26
Organization : Dr. Dale Michels
Category : Health Professional
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,
The clearer the better
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, the clearer the better
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?
It depends on how it was written.
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?
NO It doesn't make sense anyway. Look at the law about minors buying alcohol
B. If it could, would it be able to do so as practical matter and, if so, how?
No see above
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?
I don't know 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?
When one is prescription
GENERAL
GENERAL
I think all the hype about the need for this med is ridiculous. I think you will see a rise in STD's and a rise in complications from pregnancy occuring in spite of the MAP. Then we can begin to deal with babies with disabilities from our attempts to "help".