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 : EC369
Submitter : Dr. Beth Cole Date & Time: 09/20/2005 04:09:22
Organization : University of Utah College of Nursing
Category : Health Professional
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?
Yes,I believe that would be in the best interest of the American People
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?
I think the issue was clearly presented by the commissioner in the notice just prior to this comment section.
C. If so, would a rulemaking on this issue help dispet that confusion?
I believe that 'rulemaking' could help with the dilemma around 'the Morning after pill' and a responsible citizenry. There is limited expectation that adolescents assume full responsbility for themselves prior to age 16. However, young adolescents are the most vulnerable to pregnancy, whether wanted or unwanted. Too bad this discussion can not be linked to other problem-solving legislation on this problem.
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?
If additional legislation is needed can't the FDA go to Congress for such support? If the FDA has the power to do the above, then they should do so.
B. If it could, would it be able to do so as practical matter and, if so, how?
1) could pharmacists and their techicians distribute the drug on request with appropriate identification (driver's license, etc.)
2) Just as stores require ID for alcohol products could this have a similar protocol?

I see the dilemma, but accessibility is critical in a timely way for adults.
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?
No comment at this time.