HHS Overrules FDA Scientists on Lifting Plan B Age Restriction; Women’s Health Advocates Outraged
December 12, 2011
Grantee News From Reproductive Health Technologies Project
Washington, DC – On December 7th, Secretary Sebelius invoked her control through the Federal Food, Drug and Cosmetics Act to deny approval of Plan B® One-Step, a safe and effective emergency contraceptive product, overruling the Center for Drug Evaluation and Research (CDER) and Commissioner Hamburg’s recommendation to approve the application.
“We are outraged that this Administration has let politics trump science. There is no rationale for this move. This is unprecedented as evidenced by the Commissioner’s own letter. Unbelievable,” says Kirsten Moore, President and CEO of the Reproductive Health Technologies Project.
Plan B One-Step is a single dose levonorgestrel emergency contraceptive product that women can take up to 72 hours after unprotected sex. Emergency contraception is sometimes confused with the abortion pill. Plan B One-Step works to prevent pregnancy; it will not work if a woman is already pregnant. For more information on emergency contraception:http://www.rhtp.org/contraception/emergency/MediaPresskitPBOS.asp.
Contact: Lydia Stuckey, Senior Associate, Programs and Policy,