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 : EC861
Submitter : Dr. Lisa Larkin Date & Time: 10/17/2005 10:10:50
Organization : Internal Medicine and Women's Health
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?
Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
yes
GENERAL
GENERAL
Plan B should be available over the counter. The obstacles to women obtaining this very safe medication are too large. I have had several patients not be able to get this medication in a timely fashion because of pharmacist reluctance to dispense it. Appropriate use of this medication will decrease the abortion rate.

Sincerely,

Lisa Larkin MD