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 : EC678
Submitter : Ms. Kathleen Socha Date & Time: 10/12/2005 06:10:14
Organization : Ms. Kathleen Socha
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. A drug so powerful that it can kill a person shouldn't be sold at all. But if you must, then by prescription only for all ages.
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?
Yes. I take a drug sold both ways. I buy by prescription because my insurance pays for it that way.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. I think the problem lies in trying to limit the age to purchase the OTC drug.
C. If so, would a rulemaking on this issue help dispet that confusion?
Only to you.
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?
You can't even prevent kids from buying cigarettes or alcohol. What are you thinking?
B. If it could, would it be able to do so as practical matter and, if so, how?
Not possible.
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?
It would make it easier for the kids to get the right one.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When the product can kill a person. Adults die from this drug too.