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 : EC1499
Submitter : Ms. Nancy Baileu Date & Time: 10/28/2005 04:10:42
Organization : Tulare County Health and Human Services Agency
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
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?
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?
Yes
B. If it could, would it be able to do so as practical matter and, if so, how?
It would have to be regulated by the pharmacy staff, which again places a barrier to the patient.
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
My comments are related strictly to the use of Emergency Contraception (Plan B). There are many barriers to obtaining Emergency Contraception, the danger profile is minimal to the patient and would work well as an OTC product. Many pharmacists refuse to dispense the medication due to a "conscience cause" especially in this area. Many more patients would use the medications if it was more readily available. Medically, there is no reason to restrict the medicine from any sexually active female. Thank you.