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 : EC1720
Submitter : Dr. Bonnie Anderson Date & Time: 10/31/2005 02:10:14
Organization : Dr. Bonnie Anderson
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 rules do not need to be changed. There should be no further political delay in providing ALL women capable of getting pregnant from receiving emergency contraception.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only because of the FDA's illicit political actions.
C. If so, would a rulemaking on this issue help dispet that confusion?
No -- just cease and desist playing politics with women's well-being and lives.
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?
I worked for many years as a rape crisis counselor at St. Vincent's Hospital in NYC. If there had been an age barrier, numerous raped young women's lives would have been ruined.
B. If it could, would it be able to do so as practical matter and, if so, how?
This would be a cruel and unnecessary barrier, imposed on the most grievously wounded of the weak. If you're old enough to get pregnant through rape or whatever, you're old enough to prevent the resulting child. Put yourselves in the position of a 13-year-old raped by her father and think what you would want.
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?
Making emergency contraception available would make this unnecessary
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None.
GENERAL
GENERAL
I worked for many years as a rape crisis counselor at St. Vincent's Hospital in NYC. If there had been an age barrier, numerous raped young women's lives would have been ruined. I am repeating this comment from above, because I cannot overemphasize its importance. Your actions have been a cruel delaying tactic which has prevented American women (supposedly free) from an excellent remedy to unwanted pregnancy availible to women all over the "civilized" world, i.e. Europe. Shame on you!