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 : EC824
Submitter : Mrs. Helen Hund Date & Time: 10/13/2005 10:10:13
Organization : Mrs. Helen Hund
Category : Individual Consumer
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?
Dear sirs/madams,
I do not believe that "Plan B" should be marketed as an over-the-counter drug. It is dangerous to the woman and to her baby. Actually, why do you even allow the drug to be sold with a prescription? God bless the women and their babies!
Sincerely,
Helen Hund