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 : EC1994
Submitter : Ms. Betty Mitchell Date & Time: 10/31/2005 05:10:11
Organization : Lakes Region Ob/Gyn PA
Category : Health Professional
Issue Areas/Comments
I would encourge you to allow Plan B to be sold over the counter to individuals of all ages. The safety of the drug is not in question. It has a long history of use and no serious untoward effects have occurred. Regarding it's overuse as a copntraceptive in lieu of regular respnsible contraceptive use, studies to date have shown that this is not supported by studies and surveys in countries where the drug has been available for years. What has been demonstrated is that it may be underused for a number of reasons even when accessable. As a nurse practitioner who sees women every day in their practice I know the importance of avoiding unplanned pregnancies, I know that contraceptives aren't always available, that poor decisions happen as does sexual assault. The importance of preventing unplanned pregnancies is fundamental to every woman. The knowledge of and access to Plan B is long overdue. It is each healthcare providers responsibility to strive to assist their patients in achieving health and Plan B is an important part for all the women we see.