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 : EC1873
Submitter : Mr. Barry Sandler Date & Time: 10/31/2005 03:10:34
Organization : Mr. Barry Sandler
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?
The FDA has a responsibility to protect all citizens. The "EC" drug should be available to women of all ages. This will help to ensure that women or girls who do not wish to have a baby will not be forced to have an abortion. This is a women's right issue. The FDA doesn't have a right to determine morality, but they are responsible to protect the health and well being of women.
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 issue is irrelvant. Women of all ages must be able to obtain "EC" without a presciption.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
See note A above.
C. If so, would a rulemaking on this issue help dispet that confusion?
If the FDA approves "EC" being given without a prescription there isn't an issue.
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?
Women of all ages must be allowed to obtain "EC". Make whatever change is necessary.
B. If it could, would it be able to do so as practical matter and, if so, how?
See note A above.
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?
You confuse the issue. If women of all ages can obtain "EC" this is an non issue!!!!!!!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See note A above.
GENERAL
GENERAL
Women of all ages have a right to determine for themselves if they wish to prevent themselves from becoming pregnant. They must be able to obtain "EC" without interference from the FDA, State or Federal Gov't.!!!!!!!! Why are you trying so hard to dictate to women? The FDA doesn't have the right to determine morality as stated above, but is worth repeating here!!!!