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Women’s Health Advocates Applaud Movement to Remove Over-the-Counter Age Restriction Plan B One-Step®



Announcement on behalf of: Reproductive Health Technologies Project

For Immediate Release
February 10,  2011

Statement by Kirsten Moore, President & CEO of the Reproductive Health Technologies Project, on the filing of an application by Teva Pharmaceuticals with the Food and Drug Administration that would remove the over-the-counter age restriction on Plan B One-Step®:  

“We are thrilled that Teva Pharmaceuticals has submitted an application to the Food and Drug Administration (FDA) to remove the over-the-counter age restriction on its emergency contraceptive product, Plan B One-Step.

“Medical evidence shows that Plan B One-Step is a safe and effective back-up contraceptive option for women of all ages. There is no medical or scientific rationale for age restrictions on emergency contraception.  Although FDA’s request for new data from the company before removing the age restriction was unwarranted and unnecessary, we hope the FDA finally has all the information it needs to make a decision and will use this opportunity to confirm their ongoing commitment to public health and scientific integrity.  

“Things don’t always work out as planned. Timely access to an effective backup method of contraception will give more women the chance to prevent an   unintended pregnancy.”

Statement by Susan Wood, Associate Professor at the School of Public Health and Health Services at George Washington University, and Board member of the Reproductive Health Technologies Project,

“During the original review process for Plan B to go over-the-counter, the FDA reviewers repeatedly indicated that there was no medical or scientific need for new data on younger teens.  While it is good news that the FDA is now reviewing an application for removing the age restriction on over-the-counter Plan B One-Step, I hope this process does not set a precedent at the FDA for new data as a condition of approval for OTC access by teens under 17.  In addition to limiting the access for younger teens to emergency contraception, this approach could have unintended consequences, if FDA is setting out new data requirements for all OTC products used by teens.”

Background: Emergency contraception is a safe, effective back-up method of birth control that can prevent pregnancy in the first few days after unprotected sex or contraceptive failure. Current emergency contraceptive products on the market are dual labeled Plan B® One-Step and a Plan B generic, Next Choice®, as well as recently approved prescription product, ella®.

For more information about emergency contraception, please visit http://www.rhtp.org/contraception/emergency/default.asp

Kirsten Moore, President & CEO, Reproductive Health Technologies Project, and Susan Wood, Ph.D., Associate Professor at the School of Public Health and Health Services, George Washington University are available for interview upon request.



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The Association of Reproductive Health Professionals (ARHP) is the leading source for trusted medical education and information on reproductive and sexual health. ARHP educates health care providers, informs consumers, and helps shape public policy. ARHP is a non-profit membership association composed of highly qualified and committed experts in reproductive health. ARHP members are health professionals in clinical practice, education, research, and advocacy and they include physicians, nurse practitioners, physician assistants, nurse midwives, researchers, educators, pharmacists, and other professionals in reproductive health. To learn more, visit: http://www.arhp.org.