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 : EC793
Submitter : Dr. Garvan Kuskey Date & Time: 10/13/2005 08:10:44
Organization : private practice
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?
(See statement below in the comments section
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes
2
B. If it could, would it be able to do so as practical matter and, if so, how?


GENERAL
GENERAL
If 5% testosterone -- a completely benign substance -- must be written on a triplicate prescription, then why not this more dangerous preparation?

Or the reverse: if this drug can be marketed without a prescription to those over
sixteen years of age, then why can't 5% testosterone be marketed to elderly men who need HRT? The FDA designated low-dose testosterone a dangerous drug specifically because of its abuse by body builders. And yet, body builders don't use 5% preparations. In
fact, they can and do easily buy much more concentrated products in Mexico.
Because you have listed low-dose testosterone as a controlled substance, this relatively cheap substance is now priced beyond the reach of many senior men: up to $250 for a one month's supply.
I recommend that you promptly de-list it so that those needing this soy-based
bioidentical hormone can purchase it over the counter for closer to $25 for a
one month supply. Or does that make too much sense?