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 : EC652
Submitter : Mrs. Cynthia Choo Date & Time: 10/12/2005 06:10:59
Organization : Mrs. Cynthia Choo
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?
FDA should keep the drugs in question completely prescription drugs.
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?
This idea adds more schizophrenia to our society. Let prescription drugs remain prescription drugs.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is confusion in describing females younger than 16 as women. I would call these females "girls". Let them remain so. They are not adults yet. I thought that age was 21. Calling "girls" "women" changes the tone and meaning of the action.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. It would cause more confusion.
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. How would it be possible. If a mother gets the drug for her daughter, the daughter could be any age, circumventing the law's intent.
B. If it could, would it be able to do so as practical matter and, if so, how?
No.
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?
No comment.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Every time. This is making evil legal. We don't need more of that.
GENERAL
GENERAL
There are many comments available. Since you are seeking them, go to www.thefactis.org and look at their comments and at www.cwfa.org for more research on the horrific detriments to society that your proposal could be expected to bring. STD increase means infertility increase, which caused untold pain to persons who eventually want children. Breast cancer is a greater threat to women who have had an abortion, and the younger the victim (mother who had the abortion) of the abortion, the greater the chance for breast cancer later. These all increase the cost of medical insurance. I don't want to pay more because the FDA won't do regulation with what is good and healthy for people in mind.
Thank you