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 : EC58
Submitter : Dr. Vincent S. Venturella Date & Time: 09/01/2005 04:09:27
Organization : Ventura Associates
Category : Drug Industry
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. There is no need to initiate any further rulemaking for codification of the action. It is quite clear in its present form.
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 I believe the FDA's interpretation of the formal act for distinguishing the 2 parts of the isssue needs no further clarification,
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is no confusion as I read Commissioner Crawford's thinking on the manner that the decision and/or interpretation that needs to be encompassed.
C. If so, would a rulemaking on this issue help dispet that confusion?
N/A
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 do not see any deviation from the law(s) available to the FDA under the current FD&C Act that would prevent it from instituting this policy.
B. If it could, would it be able to do so as practical matter and, if so, how?
As a practical matter, I do not envision an easy way to do this specifically for Plan B. It might be possible if the OTC portion was transacted in the manner that some exempt narcotics were handled in the periods prior to the 80s, when simple ledgers were kept for limited portions of the sale of exempts during a narrow window of time. However, as was obvious then, the signer was not always the subject end user and there was no proof
that the dispensing act was aimed at the correct age group or ultimate 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?
No. There must be a distinguishing characteristic to provide for a value product. Same packaging would permit (and usually tempt) facile trading or swapping, defeating the original purpose of dual (dispensed) products.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When one cannot be secure in the knowledge that the "Prescription Only" product will be available to only the restricted group.
GENERAL
GENERAL
I believe that the product known as Plan B should be for Prescription Use only (if used at all) so that it cannot be available to any consumer under the age of 17. I further believe this is the only rational approach given the data available. The 48-72 hour use limit for effectiveness can, I believe, be adequately handled in those situations that are truely emergency events by access to any of the "24 hour" local facilities that exist in most all communities.