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 : EC669
Submitter : Mr. Larry Taylor Date & Time: 10/12/2005 06:10:27
Organization : Walgreens
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?
No
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?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, the only confusion are the special interest groups that want to rewrite the Food, Drug and Cosmetic Act.
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. This burden would fall on the pharmacist. We have a prescription status already in place that ensures proper policing. This is the proceedure that was set up in the first place to regulate moleculer entities. Why would we want to undermine the Food Drug And Cosmetic Act?
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. Why would this product receive special treatment over the already existing over the counter items? The labeling serves a purpose according the current regulations. By waving this regulation for one product you set a precedent and thus would have to wave it for other over the counter items.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
All circumstances. The prescription label and the OTC label are different, and should remain different for the protection of the consumer. If they are not why would we need pharmacists?
GENERAL
GENERAL
Pharmacists are the ones charged with policing the dispensing of prescription drugs and devices. We have a system in place that works well. Why should we under mine this and start allowing different products special consideration? This is opening a loophole for other drugs to follow. We have heard of the obstacle of access to certain drugs. Some states have set up collaberative protocols to address this question. I think this would be a better solution, then reinterprating the current act.