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 : EC1924
Submitter : Dr. Matthew Reeves Date & Time: 10/31/2005 04:10:02
Organization : University of Pittsburgh
Category : Academia
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?
No, there is no need to do this since there is ample evidence to suggest that Plan B is safe for over-the-counter use by all ages. Please see the vote and comments by the majjorit of advisory committees for details. If the FDA wishes to pursue this line of rulemaking it would be more appropriate to apply it to Tylenol (acetominophen) than Plan B.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, the only confusion is in assessing the safety of Plan B. Again, please see the recommendation of the adivsory committees for details
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?
Yes, this is currently the case with cigarettes. However, this is not necessary for Plan B as it is known to to be safe in all age groups.
Plan B should be approved for OTC sale to all age categories without further delay. Please see the initial recommendations by the advisory committees.