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 : EC716
Submitter : Mr. Joseph R Hager Date & Time: 10/12/2005 06:10:09
Organization : Citizen
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! 1. There is no way to control the dispensing that "medicine" if packaged the same.
2. As a parent, I object to a "birth control" drug being made available as an over the counter drug for my daughter under the age of 18 because I am still responsible for her health and safety, and her development, and a birth control drug available to her over the counter would usurp my parental authority.
3. Allowing an active medicinal ingredient simultaneously marketed in both a prescription drug and an OTC drug product would leave the use of the drug open to misuse/abuse.
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! See above answer.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Not able to make a knowledgeable response.
C. If so, would a rulemaking on this issue help dispet that confusion?
Unknown.
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?
I say that the pharmicist/pharmacy/store is in danger of being prosecuted because they unintentionally/inadvertantly sell an OTC drug to some one who was authorized the drug only by prescription.
B. If it could, would it be able to do so as practical matter and, if so, how?
No!
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?
Are you asking a legal question of non-legally trained people?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Without a parent's approval.