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 : EC922
Submitter : Dr. Michele Gray Date & Time: 10/27/2005 08:10:37
Organization : Dr. Michele Gray
Category : Health Professional
Issue Areas/Comments
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
NO. This would be impossible to enforce. If 17 year olds had OTC access to this drug, then there is no way of preventing them from buying it for their younger friends. The pharmacists could certainly check ID the way that it is checked for tobacco or alcohol products, but it would be very easy for 17 year olds to buy this and share it with people 16 and younger.
Making Emergency Contraception available over the counter to women and girls of all ages is a bad idea. There are very specific clinical situations in which this medication needs to be used, and in which the medication is effective. Adolescent girls would be at high risk for using this medication improperly if they were using it outside of the guidance of a physician.
Plus, this would provide contraception (although much less effective than standard contraception) outside of the physicians care. So, the patients would miss the health maintenance care that is necessary for sexually active adolescents. (STD screening, for example)