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 : EC1345
Submitter : Dr. Patty Bonney Date & Time: 10/28/2005 03:10:07
Organization : Dr. Patty Bonney
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 stop stalling on allowing ready access to Emergency Birth Control and allow women to choose whether they wish to use the emergency medicine. Politics should NOT play a part in the FDA's decision.
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?
The FDA should base its interpretation on common sense, not political dogma.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There seems to be significant confusion on the part of the FDA, and on the part of those who consider the interpretation to be strictly political.
C. If so, would a rulemaking on this issue help dispet that confusion?
An intelligent decision based on the merits of the case instead of the politics would dispel the confusion.
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?
How to meet the needs of those requiring emergency contraception should be the FDA's concern, and lawyers could work out the details once the FDA gets with the program.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't think that it would be at all practical to try to enforce such an action. We have enough trouble with dangerous illegal drugs in this country without making safe medicines illegal.
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?
Ask the lawyers if this needs to be quibbled over.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
?
GENERAL
GENERAL
The FDA has been dragging its feet on this issue for years due to political pressure, despite the public's favoring accessibility to emergency contraception without delays that requiring a prescription would involve.