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 : EC684
Submitter : Mr. JOHN HARRIS Date & Time: 10/12/2005 06:10:15
Organization : Mr. JOHN HARRIS
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?
It would be a huge mistake to allow this drug to be sold over the counter. The negative impact of taking this drug is so great that a woman needs to obtain a prescription and to be totally advised of the consequences of this medication.
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 would be best of this drug was totally removed from the market.