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 : EC639
Submitter : Mrs. Bonnie Sager Date & Time: 10/12/2005 06:10:25
Organization : Mrs. Bonnie Sager
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. The product should not be sold over the counter. period.
Much less by prescription.
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?
A product with an active ingredient such as Plan B, is unsafe
whether for under or over 16 year olds. This is not a good,
safe, and humane product.
C. If so, would a rulemaking on this issue help dispet that confusion?
No.
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?
I think it would be impossible.
B. If it could, would it be able to do so as practical matter and, if so, how?
This would necessitate time-consuming checking of identification,
etc. and lengthier waits for customers. Moreover, identity is
not that difficult to counterfeit.