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 : EC2028
Submitter : Ms. Liz Rukenbrod Date & Time: 10/31/2005 05:10:36
Organization : Ms. Liz Rukenbrod
Category : Health Professional
Issue Areas/Comments
I am a family nurse practitioner that serves low-income women in rural North Carolina. I could write about the many studies demonstrating the safety and efficacy of Plan B. Or I could write about the studies showing no increase in sexual risk-taking behaviors with the use of Plan B, however, I would rather discuss how over-the counter Plan B would directly improve the lives of my patients. It is an imperative to my patients' health and the health of their families that they have access to all family planning options. Unfortunately, cost is a barrier to care for many of my patients. Many of my families have to choose between healthcare costs (medicines, office visits, etc.) and food or rent. The number of uninsured or underinsured patients in my areas is dramatically rising. Most of my patients pay for healthcare directly out of pocket. I believe that if they had access to Plan B over-the-counter, without the added financial burden of an office visit, their lives and the lives of their families would be improved. If I can protect the health of a mother, I can also protect the health of her children. Thank you for the opportunity to comment.