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 : EC790
Submitter : Ms. Deborah Walsh Date & Time: 10/13/2005 08:10:03
Organization : Ms. Deborah Walsh
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?
prescriptions should remain pharmacy only
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?
prescriptions should remain pharmacy only
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There wouldn't be confusion if it stated simply "prescriptions should remain pharmacy only".
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes, if the ruling was "prescriptions should remain pharmacy only".
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?
Look at cigarettes and alcohol - minors find ways to purchase them all the time. Drugs should be prescription only for all peoples.
B. If it could, would it be able to do so as practical matter and, if so, how?
It could not be enforced, and it is not practical.
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?
This would have to be decided on for each drug. This is opening up an administrative nightmare. Make it easier on the FDA and the public - all drugs should be prescription only.
GENERAL
GENERAL
Teenage girls can get abortions without medical consent. So why is is the age issue of concern? Pharmacys will either choose to provide the drugs or not, either way if this passes there will be lawsuits. Healthcare providors will have to choose what they feel is morally right and risk losing their jobs. If the FDA made a simple ruling that "prescriptions should remain pharmacy only", this would solve the problem. Children 18 and under should be with their parent or guardian when picking up a prescription anyway.