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 : EC817
Submitter : Mr. Charles Seay, III Date & Time: 10/13/2005 10:10:57
Organization : Mr. Charles Seay, III
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?
I strongly urge the FDA *not* to initiate such a rulemaking: the same drug should not be marketed both ways for the same diagnosis.
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?
This appears to be essentially the same question (if not, I missed the subtlety); I would give the same answer.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I'm not familiar with section 503(b), but the issue is clear enough that the answer should be no for marketing a drug as both prescription/non- prescription for the same diagnosis.
C. If so, would a rulemaking on this issue help dispet that confusion?
I assume "dispet" is a msisspelling of "dispell." Changing the rule would only increase confusion.
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?
No. It would beg to be abused, and there is no way to enforce it.
B. If it could, would it be able to do so as practical matter and, if so, how?
No again, and no it could not enforce it.
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?
No.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If they cannot lawfully be sold in a single package, it would be inappropriate to do so under any circumstances.