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 : EC2060
Submitter : Ms. Caroline Johnson Date & Time: 10/31/2005 06:10:56
Organization : NOW
Category : Individual Consumer
Issue Areas/Comments
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 simply approve the OTC use of emergency contraception products without further delay. Even your own advisory committees came to the conclusion that these products were safe back in 2003! How much longer does it take before you approve of this important product for women? You had no problem putting Lipitor, Oxycontin, and other DESTRUCTIVE products out way before advisory committees or anything else. You are not to be swayed by political forces such as Right to Life groups, yet you seem to be reacting that way. Approve of these products now, please.
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?
error--same question
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA does not need to be concerned with the age limitations as these are addressed on a state by state basis. It is not up to the FDA to determine state's rights.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, but it would help to delay the dispensing of this product once again. As I stated in 1B above, each state has its own laws regarding availability of these products and/or abortion limitations (i.e. whether or not a minor must notify her parent(s) ).
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?
Does the FDA control the sale of alcohol, cigarettes, and other tobacco products as a part of its regular duties? Answer: No. Thus, the FDA's job is to determine safety and efficacy, not to serve as the "morality police" on behalf of any special interest group. To limit these products so that young women cannot have them would corrupt the entire democratic process. As stated above, let each state determine that...not the FDA!

B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA is not part of the judicial branch, nor is it a policing agency as far as checking ID"s, etc. Thus, this is a totally impractical question!
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?
If the product gets OTC approval, there would be no need for the prescription product--except to provide more money into the deep pockets of the pharmaceutical companies and insurance companies! And guess who generally benefits the most from prescribed medications that are also OTC? Answer: only those who can afford insurance.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This makes no sense whatsoever. I know the pharmaceuticals like to do this in their free samples, but outside of that, it would be impractical and silly to do both.
When 39 other countries can approve of this medicine, why does the FDA continue to delay the process? Perhaps the reading I've done about how the FDA is more than 50% funded by the large pharmaceuticals in this nation is true? Please stop the delay and uphold the existing laws of this nation--meaning, abortion is legal (Roe v Wade), and delaying this product should have nothing to do with what is going on politically anywhere. Thank you for taking the time to read this. All is written in my own words.