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 : EC1100
Submitter : Ms. Jennifer Haynes Date & Time: 10/27/2005 12:10:26
Organization : Ms. Jennifer Haynes
Category : Individual Consumer
Issue Areas/Comments
As a woman who is concerned about quality reproductive health access, I urge the FDA to end its delay of the decision to switch Plan B to over- the-counter status. 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, particularly for women in rural areas, making the drug available OTC is essential to the many women who would not otherwise be able to access it. Please make women's health the FDA's first priority by ending this undo
delay. Thank you for your consideration.