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 : EC1052
Submitter : Mrs. Michelle McComb Date & Time: 10/27/2005 10:10:14
Organization : Mrs. Michelle McComb
Category : Health Professional
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. The FDA has long been hailed as an independent entity that promotes public health through science and evidence, not ideology and politics. The fact that women have had to wait for more than two years for the FDA to issue a decision on the Plan B application is both unacceptable and appalling. Please make women?s health the FDA?s first priority by ending this undo delay.

Thank you for your consideration.