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 : EC1050
Submitter : Ms. pamela boehme Date & Time: 10/27/2005 10:10:22
Organization : Cumberland County Sexual Assault Prog.
Category : Health Professional
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?
To permit a woman open access to EC, is to allow her to take control of a situation in which control was taken from her without her consent. Give women the power over their own bodies rather than forcing them to face the life long ramifications of overempowerment.
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?
A woman's body is her own. She knows when she is at risk, and hopefully such initiation should allot her a beneficial option to what she can emotionally and financially support despite the 'act.'
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only among those who fight with what their hearts tell is just and what their rekigion dictates without reason.
C. If so, would a rulemaking on this issue help dispet that confusion?
No; we will continue to do as we need to for ourselves, our bodies, our souls, our future relationships. It may help change the outlook, or rather the insight of those who are blind to the eminent need of victims and women in general.
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?
You cannot base any law on economics, race, or ethnicity,
B. If it could, would it be able to do so as practical matter and, if so, how?
Ready supply in ERs for assault situations without the hassle of denials and judgements.
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?
Not alerting those with prescription coverage to be alerted to the fact that there is a less expensive equivalent.