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 : EC645
Submitter : Mr. Robert Fricke Date & Time: 10/12/2005 06:10:36
Organization : Mr. Robert Fricke
Category : Individual Consumer
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.
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.
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?
Unlikely.
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?
Not possible.
B. If it could, would it be able to do so as practical matter and, if so, how?
Impractical. The 'subpopulation' will only serve as the first purchasers who will then widely distribute these drugs at large.
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.
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 be inappropriate and dangerous without a prescription.
GENERAL
GENERAL
The reason that a prescription is now required, is to ensure that a physician examines the patient first-in order to determine the suitablitity of a drug regimen, and to evaluate the risks involved to the idividual. Patients are not competent to assess these matters themselves.
Establishing a precedent for OTC sales of this kind is certain to result in tragedy.
I have read the FDA Mission Statement, and conclude that the proposed changes are not consistent with your stated primary responsibility.