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 : EC95
Submitter : Dr. Marshall Trubow Date & Time: 09/20/2005 10:09:53
Organization : HVMA
Category : Health Professional
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?
Yes, me thinks you'r making a mountain out of a molehill with this roundabout issue on whether to allow Plan B to be OTC. The FDA's subcommittee previously recommended placing Plan B on the OTC list, only to have the political process intervene. There appear to be many interested parties in this debate, but in reality it comes down to the prolife vs abortion rights advocates, and it is clear that science is the loser when these issues become politized as this one has. If women's health were truly the issue, the data would say this is a "no brainer". It's safety has been shown, and if we really want to avoid having our patient's chose between an abortion or an unwanted pregnancy, then Plan B should be available OTC. The packaging is not the same as the already approved prescription items, and should not preclude this from being available
1.
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?
Yes-you have already done this. You can obtain Ibuprofen as an OTC 200 mg tablet, but it is also available as a prescription in 600 and 800 mg doses.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
Doubtful. We don't need more rules- we need some basic common sense to prevail, and have the politicians stay out of this.
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?
Would it really need to?