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 : EC780
Submitter : Ms. Michele Wolff Date & Time: 10/13/2005 08:10:02
Organization : Ms. Michele Wolff
Category : Health Professional
Issue Areas/Comments
I am in support of the approval of Emergency Contraception, Plan B as an over-the-counter drug. This drug is effective in reducing unplanned pregnancies and abortions and is safe for women of all ages to use. Nicotine gum, cigarettes and alcohol are already marketed to certaom age groups only. There is no reason to think that it would be too difficult and overwhelming to market EC both over-the-counter and by prescription to those under the age of sixteen.