By: Julie Rabinovitz
On December 7th, Secretary Kathleen Sebelius of the Department of Health and Human Services (HHS), overruled the Food and Drug Administration’s (FDA) decision to allow Plan B One-Step emergency contraceptive pills to be available over-the-counter without age restrictions. In her memo to FDA Commissioner Margaret Hamburg, Secretary Sebelius argued that the data was “not sufficient” given the known “cognitive and behavioral differences” between older and younger teens. The following day, President Obama spoke in support of the decision, calling it a question of “common sense.” Unfortunately, while traditionally on the side of sound preventive and cost-saving public health policies, the Secretary and President got this one wrong on both fronts.
Plan B One-Step received approval in 2006 to be accessible without a prescription for females 17 and older and available to those under 17 with a prescription. In February 2011, Teva Women’s Health, the Plan B manufacturer, submitted a request to remove the age restriction on their product based on scientific evidence that Plan B was safe and effective for all ages. The Center for Drug Evaluation and Research (CDER) was tasked with reviewing Plan B for over-the-counter use and determined that the product could indeed be used properly by adolescent females without an intervention from a health care provider.
Leading medical organizations, including the American Academy of Pediatrics (AAP), agree that Plan B One-Step emergency contraception is:
- Effective. Taken within 72 hours of unprotected sex, the pill has been shown to be 89% effective at preventing pregnancy.
- Safe. Plan B is far less dangerous than other over-the-counter drugs like Tylenol, Ibuprofen, and cough syrup. In fact, while minor side effects like nausea and vomiting exist, overdose on Plan B is impossible.
- Easy to take. Research has shown that teens understand that emergency contraception is not a primary form of birth control and they understand how to use it.
- Not abortion. Plan B prevents pregnancy and does not stop an existing pregnancy from continuing.
Based on the overwhelming data, evidence and recommendations from the AAP and other leading pediatric, gynecological and obstetric experts, the FDA was set to approve Plan B One-Step for all females of child-bearing age until the surprise and rare decision by HHS to overrule the FDA’s decision making process.
While scientific evidence has determined that there is no danger in allowing teens to access Plan B without a prescription, the risks associated with teen pregnancy are very real. Although there are success stories, research shows that pregnant teens are:
- more likely to develop life-threatening medical complications like preeclampsia
- less likely to access essential prenatal care
- more likely to have lower-birth weight babies
- less likely to complete high school
- more likely to end up on public assistance
- more likely to abuse or neglect their children
Yes, teens can still access Plan B One-Step with a prescription, but why maintain any needless barriers to access? If we really want to protect sexually active young teens, the best way to do so is by ensuring they have access to safe, effective birth control, including backup methods like emergency contraception, to help them avoid unintended pregnancies.
Teens are already doing their job. In fact, the majority of the decline in teen pregnancy rates in the United States (86%) is due to teens’ increasingly consistent contraceptive use, including use of emergency contraception. According to a report by the Guttmacher Institute, there has been an increase in teens’ use of contraceptives overall and in their use of dual methods to protect against pregnancy and STI transmission. And California’s diverse network of providers funded by Title X, the federal family planning program, are doing their share as well by reaching over 240,000 California teens annually with outreach and services in 43 of California’s 58 counties. All of these factors have contributed to a 9% drop in teen birth rates for a record low of 34.3 births per 1,000 teenagers aged 15-19 in the U.S.
Secretary Sebelius has said that Teva Women’s Health can resubmit an application to the FDA to remove the age restrictions she kept in place. In the meantime, hopefully the Obama administration has a Plan B to ensure that teens have increased access to every tool in the pregnancy prevention toolbox, including emergency contraception, so we can continue on this path of progress.
Julie Rabinovitz is the president and CEO of California Family Health Council.

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