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 : EC681
Submitter : Mrs. Kathryn Anthony Date & Time: 10/12/2005 06:10:44
Organization : Mrs. Kathryn Anthony
Category : Drug Industry
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?
Regarding persons accessing these drugs:
1. There are no complete statistics as to the damaged, even killed pregnant women who have used them. How could there be as it is a silent unseen activity.
2. Their useage is complicated and frightened poor young pregnant persons are not using them according to directions. Even if the drugs were totally safe if directions were followed
3. Women's bodies are being ruthlessly ruined without their knowledge by those with the love of the dollar and an agenda to 'reduce populations'.

This is a silent killer of children and silent dangerous method of birth-control (aborationt).

The FDA was established should be a protector of the American citizen.
Please.. protect pregnant women.

Kathryn Anthony

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?
NO.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
NO
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?
YES
B. If it could, would it be able to do so as practical matter and, if so, how?
You allowed this product to be distributed.
YOU must take responsibility for the 'silent' damage and deaths of young frightened porr women.
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?
This is an evil product damaging unsuspecting frightened young (and other- but essentially, young) interror of their pregnancy.
They are reaching out in desparation for anything that will 'take it away'.
They are told this is a safe manner. A lie.

As it is silent..there are not ways to know the results..
Just the occassional news are ticle of deaths..and worse... ruined lives.
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 inappropriate at all times.
Damaging young (children in grades schools are sexually active. Thanks to our societal acceptabnce and media hype.)
FDA need to become responsible for its action in the protection of Americans from death dealing drugs.