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 : EC844
Submitter : Mr. Dwight Rousu Date & Time: 10/13/2005 10:10:36
Organization : Private Individual
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 sounds like a very bureaucratic approach to a simple health benefit question.
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?
Any such rulemaking should not be used as an excuse to delay release of the drug for over the counter use.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There seems to be significant delay.
C. If so, would a rulemaking on this issue help dispet that confusion?
Is it confusion or obfuscation?
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?
Probably, but there is still a question in this case of whether such a limitation should be enforced at all.
B. If it could, would it be able to do so as practical matter and, if so, how?
Regardless, the question should not slow approval for over the counter release. It sounds like prior restraint questions in free speach litigation.
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?
Heck, 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?
It is hard to think of any such circumstances.
GENERAL
GENERAL
A drug deemed to be safe and to be most effective without the delays of a prescription sould be forthwith approved for dispensation over the counter. We should be making policy that supports population control; and that also helps prevent unwanted unplanned pregnancies.