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 : EC2010
Submitter : Dr. Daniel Goodman Date & Time: 10/31/2005 05:10:26
Organization : Dr. Daniel Goodman
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?
No, rulemaking is not needed.
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, rulemaking is not needed.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, there is no confusion.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, rulemaking on this issue seems designed to merely prolong the approval process, and is unncessary when the medical data is clear, as in this case.
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, similar to restrictions on tobacco.
B. If it could, would it be able to do so as practical matter and, if so, how?
See answer to A 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?
This question does not seem relevent within the context.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This question does not seem relevent within the context.
GENERAL
GENERAL
Public comment and rulemaking in this particular case truly seems like an attempt to delay decisionmaking.