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 : EC982
Submitter : Ms. Suzanne Swink Date & Time: 10/27/2005 09:10:03
Organization : Ms. Suzanne Swink
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The sooner emergency contraception is taken, the more effective it is. For some women, the requirement to get a prescription for this medication is a barrier to access. Forcing women to get a prescription harms the most vulnerable - for example, low-income women who do not have access to insurance or funds to see a doctor. Providing EC over the counter allows ALL women to access this medication.