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 : EC236
Submitter : Mr. Brandon T. Jennings Date & Time: 09/20/2005 02:09:01
Organization : Virginia Commonwealth University
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. The FDA can utilize pharmacists to enforce the law and allow for the same medication to be available OTC and Rx Only. This is especially true when the science indicates that this drug is safe and effective for self administration in certain age populations. It is quite discouraging to see a medication that can benefit the population held back because of a policy/rule loophole. This should be cleared up immediately allowing for a drug to be both OTC and Rx Only.
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.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes, and I urge you to be as clear as possible because I think you will run into more of these issues in future years.
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?
Yes. The FDA can require pharmacists to obtain proper identification from the patient upon request of the OTC medication. Pharmacists can be required to maintain logs regarding this matter.
B. If it could, would it be able to do so as practical matter and, if so, how?
If in the law, pharmacists will be subject to inspection and penalties if not followed.
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, different packaging will be required to allow for the patient to take the OTC medication without specific directions from a caregiver. I urge the manufactures to develop different packing for the OTC and Rx Only products. This will also help the pharmacist to keep the two products separate.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would not be appropriate under any circumstances.