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 : EC27
Submitter : Mrs. Deborah Pechacek Date & Time: 09/01/2005 04:09:21
Organization : Priority Healthcare
Category : Health Professional
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?
Yes I think the FDA needs to clarify this rule to eliminate any future issues.
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 definitely needs to be done to help Healthcare Professionals know when a product can be sold as an OTC product and when it can not
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Obviously there is since the Drug company is asking you to do something that I thought was not legal.
C. If so, would a rulemaking on this issue help dispet that confusion?
YES!
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 do not see how. In the case of "Plan B"; if you limit sales to 17 and older without a prescription, what is to stop 13, 14, 15 and 16 year olds with "OLDER FRIENDS" from getting the medication. The 17 year old "FRIEND" purchases it and gives it to the younger girls. Also you are opening up a great BLACKMARKET industry for the product.
B. If it could, would it be able to do so as practical matter and, if so, how?
Again - I am at a loss as to how you will control and monitor where the product goes, once it is sold.
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 - they need to be in 2 separate packages.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
ANY TIME
GENERAL
GENERAL
I think you are opening a major "can of worms" with this regulation. By allowing this to happen with one drug, you are opening the door for ANY product to use this logic. All the manufacturer has to do is show a reasonably safe side effect profile and then state that any adult is able to decide for themselves whether they want the medicaiton or not. I think we havae already put too many unsafe products out in the OTC catagory and do not need to add any more.
My other comment is about monitoring. How do you think you will prevent consumers in the NON-EXEMPT catagory from purchasing and either giving or selling the medication to people in the EXEMPT catagory? I see this as just a way for the drug manufacturers to shove their products out where anyone can buy them. This will lead to irresponsible use of medications. If we are not concerned about patient safety, the FDA might as well close down and let us buy everything in a local "DRUG STORE"... Viva la Mexico