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 :

EC32

Submitter :

Ms. Jane Hagan

Date & Time:

09/01/2005 04:09:17

Organization :

Ms. Jane Hagan

Category :

Individual Consumer

Issue Areas/Comments

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?

I believe the importance of making this drug available to the public is substantial emough that the FDA should do whatever is necessary to accomplish that.

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?

I believe the importance of making this drug available to the public is substantial emough that the FDA should do whatever is necessary to accomplish that.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

Since there is a desire to impose an age restriction on whether this drug is available with or without a prescription, there should not be significant confusion regarding whether the consumer is of a certain age or not.

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?

The answer to that question should be determined by safety issues only. If the product is safe for all subpopulations, it should be available to all subpopulations under the same conditions and without a doctor's prescription. There would be no limitation needed and therefore no law required.

B. If it could, would it be able to do so as practical matter and, if so, how?

If the product is not safe for all subpopulations based on age, then it should be limited by physician prescription and by law, and should be practical to enforce since age is provable and easily documented, particularly the age restrictions that are proposed. Both drivers' licenses and government ID cards are available for the subpopulations involved.

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?

Yes, just as other products such as tobacco and alcohol are limited to certain age subpopulations, this drug can be limited as well. Assuming enforcement will be at the point of sale, packaging should not be an issue.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

I cannot think of any, assuming that enforcement of restrictions is done at the point of sale.

GENERAL

See attachment

2005N-0345-EC32-Attach-1.DOC