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SIECUS Condemns HHS’ Override of FDA Decision to Lift the Age Restriction and Make Emergency Contraception Available Over-the-Counter for All Women

For Immediate Release                                                                                     Contact: Jen Heitel Yakush
December 7, 2011                                                                             202.265.2405 / jyakush@siecus.org
 
SIECUS Condemns HHS’ Override of FDA Decision to Lift the Age Restriction and Make Emergency Contraception Available Over-the-Counter for All Women
Decision is a Blow to Young People and a Loss for Women of All Ages
 
Statement of SIECUS President and CEO Monica Rodriguez

“The Sexuality Information and Education Council of the U.S. (SIECUS) is dismayed that Department of Health and Human Services Secretary Kathleen Sebelius is overriding the decision of the Food and Drug Administration (FDA) to finally lift the unjustified age restriction on emergency contraception. Following the evidence set forth by the Center for Drug Evaluation and Research (CEDR), the FDA was slated today to announce its decision to make Plan B® One-Step available over-the-counter to women of all ages. It is outrageous that, given the strong body of evidence and the recommendations of CEDR and the FDA, Secretary Sebelius would make this unprecedented move. To disregard the science and make such a politically motivated decision is an outrageous undermining of women’s health.

For years, experts have agreed there was no scientific or medical rationale for age restrictions on emergency contraception. Even the FDA’s own advisory committees voted unanimously nearly ten years ago that there was substantial evidence that Plan B® would be safe for use as an over-the-counter drug and voted overwhelmingly to change the status of Plan B® to nonprescription with no age restrictions. In her announcement of Secretary Sebelius’ overruling, FDA Commissioner Margaret Hamburg noted that that after a careful and thoughtful review of the data, clinical information, and analysis collected by CEDR experts, which include obstetrician/gynecologists and pediatricians,, she “agree[d]…that there is adequate and reasonable well-supported and science-base evidence that Plan B® One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

For far too long, young people’s and women’s health has been at the whim of politically driven decision makers and today’s decision is no exception. Keeping emergency contraception behind the pharmacy counter was and remains a politically motivated decision that only serves as a major barrier to accessing a time-sensitive product. Today’s decision to block reclassification of emergency contraception to over-the-counter status will undoubtedly continue to hinder women’s access to this effective method of contraception. It is unfortunate the Secretary is letting politics stand in the way of a decision that could have had a tremendous impact on improving the health of women of all ages. 

While science may finally be back at the helm of the FDA, political motivation is clearly still front and center at the Department-level. For an administration that ran on a platform of bringing science and evidence back to the helm of government, the Obama administration should be ashamed they are not following the recommendation of their own scientists and should immediately reverse Secretary Sebelius’ decision.”

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The Sexuality Information and Education Council of the United States (SIECUS) affirms that sexuality is a fundamental part of being human, one that is worthy of dignity and respect. Throughout our 48 years, SIECUS has effectively advocated for the right of all people to accurate information about sexuality and sexual health, comprehensive education about sexuality, and sexual health services. We work to create a world that ensures sexual rights and social justice.

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