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 : EC270
Submitter : Dr. Jean Shoveller Date & Time: 09/20/2005 03:09:52
Organization : University of British Columbia
Category : Academia
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?
No, please move forward with the EC OTC availability asap.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, the evidence is clear.
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?
Mute point. Get on with making this safe and effective form of contraception available to women OTC.