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 : EC1110
Submitter : Mr. Patrick Riley Date & Time: 10/27/2005 02:10:25
Organization : Mr. Patrick Riley
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?
yes, in order to subject such matters to examination by the public and other brances of the Federal Government
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?
as above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
have insufficient knowledge to judge this
C. If so, would a rulemaking on this issue help dispet that confusion?
reviewe the interpretation to make it clearer first, rather to further confuse the issue by a rule
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?
a matter for the Courts to determine. If there is serious doube as to the considered action, rethink the matter to conform with present law, not to foolishly (and expensively, too) challenge present law.
B. If it could, would it be able to do so as practical matter and, if so, how?
your problem, but historically, precedent should be followed after the best science has been applied and reviewed to each perscription or generic drug considered.


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?
i don't know - do you have lawyers on staff ?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
not knowing all possible circumstances don't know who could answer this-do you have some circumstances in mind ? loaded question
GENERAL
GENERAL
i wish to express my view in the strongest possible terms to the continued delay in aproving sale of EC drugs OTC. Your continued unwillingness to accept the approval on the record of such sales reveals a studied disregard of both the educated opinion of your advisory board and precedent. Further, your inaction constitutes and undrlines the failure of your agency which is not derelict in the prerformance of its duty to Congress and, more importantly, to the American people.