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 : EC1342
Submitter : Dr. James P Lehman PhD Date & Time: 10/28/2005 03:10:07
Organization : Dr. James P Lehman PhD
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 last thing we need is more unwanted children. Everyone should have access to any form of contraception available!
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?
Yes!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No!
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes!
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?
No!
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?
Yes!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None!
GENERAL
GENERAL
The last thing we need is more unwanted, abused, sentenced to Foster Care, and then abandoned to the streets when they turn 18, children! We need more education about sexuality, STD's, and birth control. And we need more availbility of birth control! I have read that the most pilfered items in Pharmacies are Condoms! From the presence of empty Condom boxes in Pharmacies, I would suggest that the availability of birth (and STD) control products are a major problem, which we must address as an enlightened society.