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 : EC598
Submitter : Mr. Christopher Horrocks Date & Time: 10/12/2005 06:10:50
Organization : Mr. Christopher Horrocks
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?
The FDA should stand by its practice of clear distinctions between OTC and Prescription Drugs. The complications with attempting to control distribution of these products to a sub group, of the population, are enormous and the proof of the futility of such is in the evidence surrounding the access minors have to alcohol and tobacco, where the need for ID to prove appropriate age fails again and again. If I am a teenager I need only pay an older person to buy it for me. This will create a black market trade for contraception which bares serious health risks!
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?
The FDA should stand by its practice of clear distinctions between OTC and Prescription Drugs. The complications with attempting to control distribution of these products to a sub group, of the population, are enormous and the proof of the futility of such is in the evidence surrounding the access minors have to alcohol and tobacco, where the need for ID to prove appropriate age fails again and again. If I am a teenager I need only pay an older person to buy it for me. This will create a black market trade for contraception which bares serious health risks!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only people who even need to know what that means are the drug companies and distributors; they have a pretty good idea what the rules are. They just want to get you to change them so they can make more money, at the cost of human life.
C. If so, would a rulemaking on this issue help dispet that confusion?
I think not.
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?
No. It has been a woeful mistake to have legalized tobacco and alcohol, two leading causes of death and both available without a prescription. Minors consume these products daily despite strict federal and state regulations. There is no way to open the OTC-Pandora's box, and still protect
young girls form getting their hands on these drugs.
B. If it could, would it be able to do so as practical matter and, if so, how?
I believe I have been clear in this regard; it can't be done. Despite the eloquent arguments that it can, the folks desiring to sell this as an OTC are simply coveting the profits seen in the condom industry since the so called "safe sex" movement has spread like a plague across the land. These are simply greedy uncaring drug lords who try to hide behind "FDA approval" as some sanction for their reckless endangerment of human life, for money. These drugs were not designed to fill an actual need in the public health arena they do not cure or treat a disease or illness, these drugs kill babies and endanger mothers. This isn't medicine, it's poison, and there is no more legitimacy to this, than to crack cocaine.
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?
Under current law, no.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
All.
GENERAL
GENERAL
I am a father, and am deeply concerned that my children will grow up in a world largely shaped by your decisions. They do not need exposure to greater temptation or risk of STD and worse because of the empty promises of a magic pill. Nor do they need to grow up in a world where their friends are damaged or killed by such drugs. Drugs of this power, must be administered and the results monitored by competent physicians.

Let's not ignore the fact that STDs and teen pregnancy have skyrocketed in countries where these drugs have been made available OTC! The mere availability of these drugs damage lives and increase disease. Which of course enhances the profits of the drug companies.