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 : EC1057
Submitter : Dr. Janet Novak Date & Time: 10/27/2005 10:10:42
Organization : Dr. Janet Novak
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?
If there is confusion, it seems to apply only to Plan B emergency contraceptive. Why has this medication raised the rulemaking query when a number of other medications already exist in both OTC and prescription forms? The prescription-to-OTC procedure worked smoothly for other medications, and without generating significant confusion in interpretation.
C. If so, would a rulemaking on this issue help dispet that confusion?
no
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?
yes
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes; sales of alcohol and tobacco can be legally sold only to a subpopulation (adults). Many of the merchants who sell OTC products already sell tobacco, so they are experienced with the process of checking IDs. I see no reason why the FDA cannot follow the precendent of the Bureau of
Alcohol, Tobacco, and Firearms in enforcing a law restricting sales to a subpopulation.
GENERAL
GENERAL
The proposed rulemaking appears to be a maneuver to avoid approval of Plan B for OTC status. It is very disturbing to me that the FDA, which I have long regarded as an outstanding federal agency, has become enmired in political considerations over Plan B. All the scientific and medical evidence points to the safety and efficacy of this medication. I urge the FDA to base decisions on medical considerations, not politics.