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 : EC556
Submitter : Mrs. Cyntha Bixby Date & Time: 10/05/2005 04:10:18
Organization : Another Way Pregnancy Center
Category : Other Organization
Issue Areas/Comments
GENERAL
GENERAL
I do not feel that the Morning After Pill should be sold over the counter due to the possible complications associated with it. Birth control pills themselves have enough hormones in them to cause enough side effects for them to have FDA warnings and Morning After Pills have a much higher dose of hormones in them that it seems it would sufficiently increase the possibility of the side effects such as blood clots. Over the counter sales would not regulate these side effects on a continuous basis and would be sold or given to minors who would possibly be even more affected by these side effects.