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 :

EC33

Submitter :

Dr. Mark Collum

Date & Time:

09/01/2005 04:09:30

Organization :

Dr. Mark Collum

Category :

Health Professional

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?

Plan B should be either OTC or available to be prescribed by a pharmacist. Pharmacists can verify if a patient is above 16yo, and can then allow it to be dispensed. However, a licensed RPh should be the one making the decision. This will satisfy the requirements that it only be available to someone who is 16yo. It will allow a label to be generated and offer the RPh to counsel the patient regarding its use.

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. This should either be fully OTC or it should be classified into a category where RPh can prescribe and dispense it.

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

Yes. It is written entirely in legal jargon which most people cannot understand. In fact, even highly educated health professional must consult lawyers as to its interpretation. It needs to be worded such that a "regular" person can understand its provisions. Remove all legal jargon and replace it with intelligible phrases and words.

C. If so, would a rulemaking on this issue help dispet that confusion?

NO! More rules only add to the confusion. Medicine & Pharmacy are too highly regulated as it is. More rules = more confusion.

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. If pharamcists are allowed to prescribe and generate a label for those greater than or equal to 16yo, anyone who receives it who is under 14yo must have received it from a phycisian. By making RPh generate their own prescription and treat it as such, there is a tracking method and accountability for anyone who receives the product.

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

By allowing RPhs to treat Plan B as a member of their "prescribing class," you put the responsibility on their shoudlers. If someone under the age of 16 were to receive the product, it should have a physician's approval or the RPh would have violated his/her duties as a licensed professional and be subject to discipline.

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. Their packaging should be different and distinct.

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

It is inapprorpiate to allow one single package to represent two products...that is deceptive to all parties involved.

GENERAL

non