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 : EC2022
Submitter : Mrs. Margaret Munro Date & Time: 10/31/2005 05:10:59
Organization : Mrs. Margaret Munro
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 - the FDA should not initiate rulemaking.
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 - the FDA should not initiate a rulemaking to codify its interpretation.
GENERAL
GENERAL
It is not the FDA's job to create public policy, merely to judge on the safety and efficacy of pharmaceuticals, and to keep the food supply safe. Rulemaking may be effective in cases where dosages need to be monitored in order to keep a pharmaceutical safe and effective - beyond that question, the FDA should not be creating rules; if action is needed to keep a pharmaceutical from a certain group of people, let Congress create and pass that legislation, and let them bear the responsibility of their actions.