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 : EC1263
Submitter : Mr. Roddy Jackson Date & Time: 10/27/2005 05:10:22
Organization : Mr. Roddy Jackson
Category : Drug Association
Issue Areas/Comments
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?
Just approve it OTC, for God's sake!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes! Just approve it OTC!
C. If so, would a rulemaking on this issue help dispet that confusion?
No! Just approve it!
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?
If the drug is safe, approve it and let the lawmakers decide the rest.
B. If it could, would it be able to do so as practical matter and, if so, how?
Absurd. Approve it.
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?
Approve it OTC.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Unwanted children are more likely to engage in criminal behavior. We already have an overpopulation problem that continues to get worse. It's not the FDA's job to moralize; It's your job to approve drugs that are reasonably safe to use. Do your job and approve this drug. Let the lawmakers and courts decide the rest.