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 : EC728
Submitter : Mr. Barry Kroeker Date & Time: 10/13/2005 08:10:00
Organization : Mr. Barry Kroeker
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?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
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?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
C. If so, would a rulemaking on this issue help dispet that confusion?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
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?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
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?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.
GENERAL
GENERAL
The FDA should immediately ban all sales of the abortion pill, which serves NO MEDICAL PURPOSE other than to KILL UNBORN CHILDREN IN THEIR MOTHERS' WOMBS.
The FDA FAILS IN ITS PRIMARY ROLE TO PROTECT THE PUBLIC HEALTH WHEN ITS LEADERS PERMIT AND/OR CONDONE THE MANUFACTURE, MARKETING AND/OR SALE OF HUMAN PESTICIDES.