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 : EC940
Submitter : Ms. Suzanne Mock Date & Time: 10/27/2005 08:10:09
Organization : Pharmacy Student
Category : Health Professional
Issue Areas/Comments
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 should be spelled out very clearly for practitioners and pharmacists, alike, so they cannot misunderstand the language. Selling this product as both a prescription product and an OTC product should not be much different from what is happening now with physician/pharmacist agreements regarding many medications.
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 believe this could occur. Pharmacists are law-abiding citizens like most other people of this country. Handing out PlanB like candy is not ethical or lawful and most pharmacists would not be willing to do this. Enforcing this law would not be an issue for this medication.
B. If it could, would it be able to do so as practical matter and, if so, how?
This could occur, as well. Already, pharmacists are allowed to dispense this medication with a previous written consent from a licensed physician and later receive a written prescription. A questionnaire for the patient wishing to receive this medication would not be impractical for a pharmacist to go through with the patient.
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?
The same active ingredients that are sold both over-the-counter and by prescription, such as ibuprofen, do not have the same packaging. It would be best for both legal and reasonable practices to be sold under different packaging. This would make it easier for the pharmacist to differentiate between the two products.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I think having the same packaging for the medication would make the pharmacists' job more difficult. I don't believe that it would be appropriate under any circumstances for this product to be dispensed in the same packaging.