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

February 10th, 2011 • Contributed by Dino Corvino
Posted in: Emergency Contraception

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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 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

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