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 : EC720
Submitter : Mr. T J Myshka Date & Time: 10/12/2005 06:10:01
Organization : None
Category : Individual Consumer
Issue Areas/Comments
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?
I respectfully request that you not allow a prescription drug be allowed to be marketed as an over the counter drug product; this appears to be a contradictory statement. You allow people to determinate the sacred life of a human being at conception and you allow a human being to terminate their life because of an irreversible illness; and yet senior citizens who want to maintain a healthy life style with food supplements do not want these to be classified as prescriptions.
I do not see the logic in this type of thinking. BE VERY CAREFUL, because if you allow this drug to be sold as a prescription and as an OVER THE COUNTER drug you WILL be OPENING the door to lobbying groups to legislation for many more prescription drugs as over the counter drugs. You should not allow prescription drugs to be sold as OTC drugs, because you will not be able to STOP the PRESSURE from organizations applying pressure for their unique causes. What I believe would be better is to allow a physician to authorize a patient to purchase this particular drug on a case by case bases. What cannot be predicted now, is how will this drug enter the black market for other types of abuse and it will, if NOT regulated.
This appears to be very logical and straightforward, but I am afraid it can have very ugly consequences in the future. PLEASE look at the past history to see what I mean. Again I ask to continue making sound judgments for the sake of the total health community. May I thank you ahead of time for reading this comment.