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 : EC781
Submitter : Mrs. Theresa Otto Date & Time: 10/13/2005 08:10:17
Organization : Mrs. Theresa Otto
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?
They should initiate a rule making
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?
Issue a rulemaking.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Much confusion.
C. If so, would a rulemaking on this issue help dispet that confusion?
I do not believe the government would be able to regulate this. When something is sold OTC, it cannot be regulated. The morning after pill is very dangerous, and can cause many deaths.
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?
CANNOT BE DONE,
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?
Legal does not mean it is good.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It is most definitely inappropriate, to sell to teen-angers, since it can cause death. We are speaking here about the Morning after pill.
GENERAL
GENERAL
Drugs such as birth control pills and the morning after pill, have done nothing good for society. If we did not have foreigners becoming US citizens, this country would really be in trouble.