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 : EC821
Submitter : Ms. Lenore Satterfield Date & Time: 10/13/2005 10:10:55
Organization : Ms. Lenore Satterfield
Category : Individual Consumer
Issue Areas/Comments
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. The FDA is inconsistant and too political.
C. If so, would a rulemaking on this issue help dispet that confusion?
I hope so.
Barr Laboratories should be able to sell Plan B emergency contraception OTC in order to prevent unwanted pregnancies and dangerous abortions. Plan B can ease the minds of rape victims and eliminate the need for abortions. FDA rulings should be based on medical reasons, not religious or political ones.