Ibis Reproductive Health surprised, disappointed by Secretary Sebelius’s overruling of FDA Plan B One-Step decision
December 7, 2011– Ibis Reproductive Health is surprised and extremely disappointed that Department of Health and Human Services Secretary Kathleen Sebelius stepped in and overruled the Food and Drug Administration’s (FDA) decision to make Plan B One-Step available over the counter (OTC) for all women. The Secretary’s action is an unprecedented interference in the FDA’s expert review process. Data convincingly show that Plan B One-Step is safe for women of all ages and that the instructions on the label are easy to follow. The Secretary provided no explanation of what risk or concern she has for younger teens, and she inserted her own opinion in the place of scientific expertise at the Center for Drug Evaluation and Research at the FDA.
Levonorgestrel emergency contraception (EC) is safe and offers women a second chance to prevent pregnancy after unprotected sex. ALL women who are at risk of pregnancy—no matter how young or old—should have access to EC with as few barriers as possible in order to prevent unintended pregnancy and protect their health. This decision affects and harms ALL women because it keeps EC behind the counter, instead of making it available on the drugstore shelf, 24/7, so women can access it as soon as they need it.
Secretary Sebelius should let the FDA do its job. We at Ibis are dismayed that the Obama administration is not keeping its promise to make decisions based on the best science. We call on Secretary Sebelius to allow the FDA to move forward with its approval of full-OTC access to Plan B One-Step and for President Obama and this administration to stand up for science and for women.