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 : EC1010
Submitter : Ms. Barbara McDaniel Date & Time: 10/27/2005 09:10:51
Organization : Ms. Barbara McDaniel
Category : Individual Consumer
Issue Areas/Comments
Plan B has been determined reasonably safe for OTC distribution.
Plan B has been determined useful to help prevent unwanted pregnancies.
Plan B use has no bearing on increase/decrease in promiscuous behavior of men.
Plan B is contraception, for which women are entitled access.
Compulsory pregnancy is contrary to American ideals of life, liberty, and the pursuit of happiness.
Therefore, there should be no further hesitation for the FDA to approve Plan B for OTC availability for all women of child-bearing capability.