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 : EC909
Submitter : Mrs. Judith Bayba Date & Time: 10/18/2005 01:10:23
Organization : Mrs. Judith Bayba
Category : Health Professional
Issue Areas/Comments
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The former interpretation that a drug is either prescription or over the counter was not confusing. Having a certain drug available as a presciption at a certain strength and over the counter at a weaker strength would be understandable. If one drug is available in alternate forms and for alternate purposes as Rx and OTC would also be understandable. The current application for Plan B to be OTC and Rx for the same purpose and in the same form would lead to much confusion for that particular drug and potentially for many others.
C. If so, would a rulemaking on this issue help dispet that confusion?
I doubt it.
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?
Absolutely not! Don't underestimate the ingenuity of any population group to obtain what for them would be not available. Cigarettes and alcohol are prime examples of the inability for such a plan to succeed.
B. If it could, would it be able to do so as practical matter and, if so, how?
There would be no practical method to enforce such a limitation!
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?
That would again make enforcement even more impossible.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If the separate groups are not clearly discernable at all times to all persons involved in the dissemination and enforcement, it would be inappropriate. (A group of persons under three feet tall, with the other group of pesons over seven feet tall, would be obvious. A group with a birthdate dividing line is not obvious.)
As a BSN and a mother of a soon to be 16 year old daughter, I am very concerned about the possibility of Plan B and other similar drugs being available over the counter to anyone. Plan B is not without potential medical complications, even when used under the care of a physician and in full compliance. This drug would not be used as "emergency contraception" only if it becomes available over the counter. An increase in STD's would very likely become an ever increasing public health concern. Also, if the age of legal adulthood is 18 years old, why are minors considered to have adult responsibility in the area of reproductive health concerns? Parents should not be excluded from this important area of their children's lives. Others (i.e. similarly immature children, or sex offenders) can often easily pressure for unwise, unhealthy, and even dangerous decisions. Please do not put that pressure on our children unnecessarily!