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 : EC952
Submitter : Dr. Christopher Duggar Date & Time: 10/27/2005 08:10:43
Organization : Central Alabama OB/GYN Associates, PA
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?
As a health professional, I am opposed to marketing any drug, but especially Emergency Contraception, as both an over the counter and prescription drug because it makes it too easy for young, vulnerable teenagers and women to gain access to a potentially harmful drug...In addition, it opens the door for abuse by pharmacies, their staff, and other health professionals to skirt the regulatory laws and offer over the counter drugs that are meant to be prescription only...Also, it makes the distribution of that said drug confusing as you are forced to constantly be checking age and identity for some but not all patients...Either a drug should be prescription OR OTC...Not both...
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
No
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, not without a very costly oversight plan
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?
No, because then how do you verify that the OTC product is not really meant to be prescription...
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Emergency contraception