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 : EC798
Submitter : Mrs. Gloria Kindon Date & Time: 10/13/2005 08:10:55
Organization : Mrs. Gloria Kindon
Category : Consumer Group
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?
This is not a good drug and should not be sold
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?
If a drug can be sold OTC there should not be another version of it at a higher cost sold by prescription.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I think in the pro-choice circle there is confusion. The Pro-Life circle does not want this sold at all or give out under a Dr.
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?
It should not be sold under any circumstance.
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?
It should not be lawful.
GENERAL
GENERAL
I feel that this is an extremely dangerous drug. It should not be sold by prescription or an OTC drug. The number of deaths related to this drug are to high esp. in cases that have been unsupervised. Selling this drug would only increase these numbers dramatically esp. to anyone under the age of 21. This drug still kills an unborn child and should not be marketed.