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 : EC662
Submitter : Mr. TONY NGUYEN Date & Time: 10/12/2005 06:10:48
Organization : KAISER
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
We already 'require' takers of Accutane to not be pregnant, takers of Lotrenex to have predominantly diarrheal-IBS, takers of Clozapine to have normal WBC levels. Requiring PlanB takers to be over 16 is of a similar concept, that being risk management.
There are some great drugs unavailable to the public because we are unwilling to manage their risks. On the other hand, we currently use many risky drugs without any consideration to their risks!
All drug use could be so much more useful when targeted to the right population. And genomics will guide us there.
The FDA needs to make this bold leap.