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 : EC783
Submitter : Miss. Christie Kwan Date & Time: 10/13/2005 08:10:37
Organization : Miss. Christie Kwan
Category : Health Professional
Issue Areas/Comments
Please do not change PLAN B to an over-the-counter drug! Even with age restrictions, a teenage girl could get it if her older boyfriend bought if for her. Making the product available OTC would thus enable statutory rapists/sexual predators to cover up their crimes more easily. Even if the drug sales were restricted to women over the age of 16, it wouldn't be hard for predatory men to get them for their underaged sexual partners.