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 : EC1940
Submitter : Dr. Nina Salama Date & Time: 10/31/2005 04:10:30
Organization : Dr. Nina Salama
Category : Individual Consumer
Issue Areas/Comments
I am writing specifically about the delay in granting approval for the "morning after" oral contraception. Two FDA reviews of this compound have recommended its approval for over the counter use, yet the FDA leadership has not made a decision and has asked for public comment and rule making. This gives the appearance of political decision making. This is not appropriate for a public agency whose mandate is to protect human health. I encourage the FDA to dispense with the politics and approve this drug for over the counter use based on the safety data.