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 : EC625
Submitter : Mrs. Janet Crook Date & Time: 10/12/2005 06:10:45
Organization : Mrs. Janet Crook
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?
Plan B should only be available by prescription. I would rather it were not available at all as it is probably like other contraceptives and is an abortafacient also.
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?
Plan B should only be available by prescription. I would rather it were not available at all as it is probably like other contraceptives and is an abortafacient also.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion on the part of the FDA began with the allowance of the first birth control pill.
C. If so, would a rulemaking on this issue help dispet that confusion?
The only thing that would help dispel the confusion would be to ban all contraceptives as they are abortafacients and also a significant cause of breast cancer in women
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, because then the Federal Government would be complicit in murder of millions more babies.
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
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
In all circumstances would it be inappropriate to do so. You are either condemning a woman to be complicit in the murder of her unborn child and are setting her up to get breast cancer later in life.