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 : EC2096
Submitter : Ms. Barbara Fries Date & Time: 10/31/2005 06:10:05
Organization : Ms. Barbara Fries
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
As someone who is concerned about women?s access to safe and medically necessary contraceptives, I urge the FDA to end its egregious delay of the decision to switch Plan B?s drug status to over the counter (OTC). 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.