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 : EC171
Submitter : Mr. Mike Pinkerton Date & Time: 09/20/2005 02:09:37
Organization : Humanity
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?
No. I believe that the interpretation is overly restrictive and ignores situations such as this (appropriate for a sub-population)and should not be codified. Case by case determination is more appropriate.
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?
No. The interpretation is too restrictive
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Affirmitive, you seem quite confused between your role in approving drugs on scientific merit and benefit (vs social engineering and backdoor legisalated morality).
C. If so, would a rulemaking on this issue help dispet that confusion?
No. A reminder to the FDA that its role is to approve or dissapprove drugs for use based on potential harm and validity of claims is needed.
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?
Not relevant. Other such enforcement is already performed: alcohol, tobacco, pseudopherine, spray paints and other inhalable solvents, ...
B. If it could, would it be able to do so as practical matter and, if so, how?
See answer to A above. Follow the existing models.
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?
Differentiation should only be required if it can facilitate enforcement.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When the package differentiation is necessary as part of enforcement procedure.
GENERAL
GENERAL
I do not believe that this should be restricted for any age group. I believe that this is a necessary part of giving underage pregnant females a chance to prevent unintended pregnancy. With the explosion of unwanted pregnancy in females under 16 anything that allows them to address the mistake is a positive step. Young females will not tell parents or doctors, but will try this if its available. Requiring a doctor or parent will simply make this inaccessible.The staggering statistics regarding the impacts of inintended teen pregnancy on society as a whole include the continuation of the cycle of poverty/lack of education/low income/crime that many unintended births feed. How moral is that?