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 : EC680
Submitter : Mr. Stan Schulz Date & Time: 10/12/2005 06:10:35
Organization : Christian Leadership Alliance in Memphis
Category : Consumer Group
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. This would open the floodgates for evermore trivial excuses to market products which have been judged dangerous enough to require professional oversight -- through a prescription.
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. This would open the floodgates for evermore trivial excuses to market products which have been judged dangerous enough to require professional oversight -- through a prescription.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No confusion regarding present practice; plenty of confusion over what may happen in the future.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. It would only change a simple "esy/no" issue into a complex one requiring measurements (of age, for instance) or status (married or not), and set the groundwork for requiring additional bureaucratic action (for instance, requiring proof of age)and the possibility of fiviolous lawsuits based on the decision of a drugstore clerk.
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?
Probably not. It would result in lawsuits challenging the right to restrict sales; challenging the appropriateness of the cutoff age, alleging age discrimination.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. As a practical matter, any young girl could find a friend over the age of 16 who could buy the drug and give it to the youngster. Also, any young MAN over the age of 16 would gladly buy the drug for his underage lover.
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?
Sure. The packaging would make no difference --- it's the person making the purchase who makes the difference.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There are not "two products". They would be the same with just different locations and sales restrictions.
GENERAL
GENERAL
Any product which has been judged sufficiently dangerous to warrant professional supervision via prescription -- should not be presented to the public without such protection. It opens the product to many forms of abuse -- purchase of the product by one qualified person for the use of another unqualified person; purchase of multiple packages of the product for over-use "just in case"; purchase of the product with intent to resell it at a profit to an unqualified person, etc.