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 : EC736
Submitter : Mr. Wayne Hill Date & Time: 10/13/2005 08:10:00
Organization : Mr. Wayne Hill
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?
ABSOLUTELY NOT! It sets a dangerous president!!
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
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?
ABSOLUTELY NOT! It sets a dangerous president!!
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
APARENTLY
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
C. If so, would a rulemaking on this issue help dispet that confusion?
ABSOLUTELY NOT! It sets a dangerous president!!
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
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?
ABSOLUTELY NOT!
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA cannot even enforce it's current rules!
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?
ABSOLUTELY NOT! It sets a dangerous president!!
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
All situations!
In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!
GENERAL
GENERAL

In my humble opinion, this drug should be outlawed totally. This "Plan B" idea is dangerous at best and should NOT be available PERIOD! DO NOT ALLOW This drug or combination of drugs called collectively as "The Morning After Pill" to be available at all!!