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HHS Secretary Kathleen Sebelius Overrides FDA Decision to Make Emergency Contraception More Broadly Accessible

December 8, 2011

On December 7, 2011, Health and Human Services Secretary Kathleen Sebelius overruled the U.S. Food and Drug Administration’s (FDA) decision to make Plan B One-Step emergency contraception available over the counter for all women. For the HHS secretary to overrule a recommendation from the FDA on any drug-related application is unprecedented. Approval by the FDA would have made the emergency contraceptive available, alongside condoms and pregnancy tests, on the shelves of pharmacies, grocery stores and other retailers, giving all women at risk of unintended pregnancy timely access to this safe and effective backup contraceptive method without having to ask a pharmacist or get a prescription from a doctor. The decision by Sebelius means that Plan B One-Step will continue to be available to women 17 and older from “behind the counter” and available to those under 17 by prescription only.

The facts in this case are clear. After a thorough and months-long review of the evidence by the FDA’s Center for Drug Evaluation and Research, FDA commissioner Margaret Hamburg announced on December 7 that she concurred with the Center’s recommendation to make the emergency contraceptive available as a nonprescription drug. She stated that there is “adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of childbearing potential.”

Yet despite the official commitment of the Obama administration to scientific accountability in political decision-making, Secretary Sebelius ignored that body of evidence, overriding the FDA decision. Her stated rationale? To ensure that teens as young as 11 years old would not be able to obtain the medication without guidance from a health care professional. However, Sebelius’ focus on 11-year-olds is specious. Fewer than 1% of 11-year-old girls are sexually active, but almost half of girls have had sex by their 17th birthdays, and most of these begin at age 15 or 16. Recent government data from the National Survey of Family Growth suggest that the age restriction on emergency contraception has limited use of the method among this demographic, even as use increased substantially among older teens and young adults. Continuing to restrict access will only increase the number of teens faced with an unintended pregnancy.

Unintended pregnancy is a key public health concern today, and women of all ages should have the tools they need to stay healthy. This includes having access to a backup birth control method if their primary method fails or if they have unprotected sex. While some people are uncomfortable with the idea of teens having sex, the fact is that the large majority of people begin having sex during their teen years. At the same time, there is no evidence to suggest that making contraceptives available to teens encourages them to engage in sexual activity; rather, it helps those teens who are already sexually active to avoid unintended pregnancies. Moreover, available evidence indicates that adolescents are just as likely as adults to understand medical labeling in order to take emergency contraception safely.

“Emergency contraception is more effective the sooner it is used, so it is critical that women of all ages are able to get it quickly and easily, without having to jump through unnecessary hoops,” says Sharon Camp, president and CEO of the Guttmacher Institute. “Secretary Sebelius’ decision to ignore the scientific evidence and keep Plan B One-Step off the shelves of local grocery stores and pharmacies is a huge disappointment.”

Click here for more information on women’s use of emergency contraception

Click here for state policies on emergency contraception

Click here for more information on teen pregnancy

Click here for more information on teens’ sexual and reproductive health

Click here for information on emergency contraception in the US global family planning effort