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 : EC666
Submitter : Mr. Don Vasas Date & Time: 10/12/2005 06:10:52
Organization : Mr. Don Vasas
Category : State Government
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 - your opening remarks addressed that there is seldom a time when a drug is OTC and prescription. I would not codify because there seems no need to codify when there is not a great need to. Handle it as a case by case.
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 - your opening remarks addressed that there is seldom a time when a drug is OTC and prescription. I would not codify because there seems no need to codify when there is not a great need to. Handle it as a case by case.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No
C. If so, would a rulemaking on this issue help dispet that confusion?
No. Look at the bible and the constitution.
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
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. How will law enforcement ever know what is prescription and OTC? There should be a significant difference where a reasonable person would instantly see the difference. Children abuse perscription drugs and OTC drugs...we should make it easy to spot the difference for our parents, teachers, coaches and those around kids.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Never appropriate to put in same package
GENERAL
GENERAL
The Morning After Pill should not be allowed as OTC. It is now at age 16 - that's it! I don't see how you could make it less restrictive than that...except to make it OTC! It is a drug regardless if in the hands of a 12 or 16 or 32 year old. Think about the lack of control over this drug that will then occur?! When and if it is OTC then it will be handed out in the middle schools like condoms are handed out. Think about the confusion that will take place as counselors across America start giving this to kids AND not telling parents. The only reason the drug company wants it to be OTC is so that it can open it to a larger market and make more money. Honestly - come on FDC and protect the little ones...