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 : EC575
Submitter : Mr. Ed Cunningham Date & Time: 10/12/2005 06:10:25
Organization : Mr. Ed Cunningham
Category : Individual Consumer
Issue Areas/Comments
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 doesn't allow competition when it comes to approving herbal cancer treatments,but it is OK to market an abortion pill to a 16 year old? The FDA has no moral compass!
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?
what is a subpopulation? Inner city black & hispanics? Abortion is murder! Is it cheaper to kill them now then feed them later?