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 : EC1728
Submitter : Ms. Kristie Gantt-Bean Date & Time: 10/31/2005 02:10:43
Organization : Ms. Kristie Gantt-Bean
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?
The FDA should certainly approve OTC emergency contraception. There have been numerous studies on it to conclude that it is safe and effective.
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?
same as above answer
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I am not aware of any confusing interpretations and cannot respond to this. Simply put, approve the OTC emergency contraception. It should be available to Americans everywhere. Also, while I support pro-choice, I think that having emergency contraception could reduce the need for abortions late in preventing the conception of occuring.
C. If so, would a rulemaking on this issue help dispet that confusion?
Be clear in your rules and regulations. Period. Make sure when you publish it and make it available, there are guiding rules that are clear. But make this drug available. Europe laughs at us for how we hold back on drugs like this. There is no reason to hold this up.
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?
If it is truly "OTC" then that implies it is a drug you can buy right off the shelf as any other product, say Tylenol. There aren't any requirements for a prescription or identification to buy OTC Motrin or for condoms. While I do not think emergency contraception should be the chosen method for continued contraception, I think it should be available OTC anonomously.
B. If it could, would it be able to do so as practical matter and, if so, how?
Again, I think that requiring a prescription or identification would be intrusive and unnecessary. In the case of requiring a prescription, it would delay matters to the point that it would nullify itself. (to get an appt, have an exam, receive the prescription, fill it and take it).


3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Why would it be handled this way? Make it available OTC. Period.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See response above. I don't think you need two packages. Have one, and have it available the same way: OTC.
GENERAL
GENERAL
Please continue your progress with making this drug available to American women everywhere. Thanks for your time in considering my responses.