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 : EC2063
Submitter : Ms. Beth Kaimowitz Date & Time: 10/31/2005 06:10:04
Organization : Ms. Beth Kaimowitz
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
FDA should not initiate rule-making. Rule-making here is a political decision, not based on scientific fact or research. Approval of morning- after contraceptive should follow the same steps as that for other medications. As a consumer, I want morning-after contraceptives to be accessible on the same terms as other medications, such as medications for vaginal yeast infections.