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 : EC859
Submitter : Ms. Anne Koerber Date & Time: 10/17/2005 10:10:45
Organization : Ms. Anne Koerber
Category : Individual Consumer
Issue Areas/Comments
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?
Since the FDA is clearly making the changes because of the special instance of Plan B, and the change is initiated because the FDA doesn't want teens to use Plan B rather from any medical concern about the use of it in teens, then it is not useful to alter the rules for one instance for political rather than medical reasons.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion is not over the FDA's interpretation, the confusion is a result of the FDA taking an action for political rather than medical reasons.
C. If so, would a rulemaking on this issue help dispet that confusion?
The FDA shoulc apply its rules consistently for medical and not political reasons.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't see how it could be enforced practically.
The FDA has been guilty of making decisions in response to political pressure from right-wing groups. Decisions about availability should be based on medical safety and nothing else. This controversy has seriously undermined (along with other recent events) the public's ability to trust the FDA. I urge you to 1. make Plan B available on an OTC basis, as the FDA originally ruled, and if not, 2. stop delaying the decision and at least make it available to adult women right away.