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 : EC797
Submitter : Mrs. Julie Lowicki Date & Time: 10/13/2005 08:10:42
Organization : Mrs. Julie Lowicki
Category : Health Professional
Issue Areas/Comments
There is more than one legal issue at hand involving the age of consumers who would purchase an OTC drug that was otherwise a prescription. The use of a contraceptive comes with MANY health risks to all age groups and should in no way be an option for an over the counter drug. The risks are not limited to the following:blood clots, liver disorders...etc. The risks are higher for women over the age of 35, or women who are smoking...etc. There would be no way to regulate properly the sale of this drug to healthy women. It is a bad idea all together without involving the severe moral dilemma of having an abortifacient sold as an OTC drug.