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 : EC937
Submitter : Dr. allan weingold Date & Time: 10/27/2005 08:10:18
Organization : Dr. allan weingold
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?
no
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?
no
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
not on the part of FDA professionals or the overwhelming majority of obstetricians and gynecologist. only in the view of the commissioner and his handlers in the white house.
C. If so, would a rulemaking on this issue help dispet that confusion?
what is the menaing of "dispet"? i suggest that you follow the advice of your professiinal panels.
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?
absolutely not!! nor should it identify such sub-populations
B. If it could, would it be able to do so as practical matter and, if so, how?
again, no.
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 question makes absolutely no sense. the product in the EC controversy is a single product.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
see above
GENERAL
GENERAL
adolescent unplanned pregnancies increase the abortion rate.the solution is prevention INCLUDING ACCESS TO EMERGENCY CONTRACEPTION.