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 : EC1068
Submitter : Ms. Jean Richards Date & Time: 10/27/2005 10:10:27
Organization : Ms. Jean Richards
Category : Individual Consumer
Issue Areas/Comments
Contraceptives are a fundamental element of basic health care for
most sexually-active women of childbearing age. Plan B, a safe and effective form of contraception, decreases the risk of unintended pregnancy resulting from unprotected sex or contraceptive failure
by 89%. For women who want to avoid the health, economic, and social costs that unintended pregnancy carries for them, their children, and society as a whole, easy access to this drug is essential. For Plan B to be effective, women must be able to take it quickly, as the efficiency rate decreases dramatically after 12 hours following unprotected sex, birth control failure or sexual assault. Because
it is often not possible to quickly schedule an appointment with a health-care provider who will write a prescription, making the drug available OTC is essential to the many women who would not otherwise be able to access it.
Many developed countries already provide OTC access.
How much longer will American women have to wait to do the same?