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 : EC1905
Submitter : Mrs. Jennifer Lodge Date & Time: 10/31/2005 04:10:33
Organization : Mrs. Jennifer Lodge
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Morning after contraception is critical for prevention of unwanted pregnancy, and therefore critical to women's health and well being. It should be approved on the scientific merits, and not held up for politics!!!

Rulemaking is certainly not needed in this instance.