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 : EC719
Submitter : Mrs. Eileen Peterson Date & Time: 10/12/2005 06:10:50
Organization : Rachel Ministry
Category : Other Organization
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 should not make this mroning pafter pill available over the counter. I minister to those who have taken this dangerous drug and they are physically and emotionally sick.
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 dangerous drug should not be sold to anyone unless a doctor has given the order
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is not confusion. This is about using our children for profit and it is immoral.
C. If so, would a rulemaking on this issue help dispet that confusion?
Rule to keep this dangerous drog out of children's hands
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 do not know.
GENERAL
GENERAL
I am a mother of seven children and I have devoted my life to helping young people heal after they have lost their babies to abortion, miscarriage or stillbirth. This is a dangerous drug that will harm out children greatly. Keep this off the shelves. God Bless You.