Online StoreDr. Margaret Hamburg, the Commissioner of the United States Food and Drug Administration (FDA) announced today that Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled the FDA’s decision to allow Plan B One-Step, emergency contraceptive pills, to be available without a prescription for all ages.
Plan B One-Step received approval in 2006 to be accessible without a prescription for females 17 and older and only available to those younger than 17 with a prescription. In February 2011, Teva Women’s Health Inc, submitted a request to remove the age restriction on their product based on studies they had performed that provided scientific evidence that Plan B One-Step was safe and effective for all ages. The Center for Drug Evaluation and Research (CDER) was tasked with reviewing Plan B One-Step 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.
Based on the data, evidence and recommendation from CDER experts including obstetricians, gynecologists, and pediatricians, the FDA was set to approve Plan B One-Step for all females of child-bearing age until the surprise move this morning by HHS to intervene.
“Today’s announcement comes as a big shock and disappointment,” said Julie Rabinovitz, President and CEO of California Family Health Council. “Secretary Sebelius’ decision to reverse the FDA’s charted course to approve Plan B One-Step for over-the-counter use without an age restriction flies in the face of science. For the past few years the public health community has been feeling a certain sense of relief that the FDA had returned to making decisions based on sound scientific evidence and not politics. It’s worrisome that under the current administration, that might not entirely be the case,” added Rabinovitz.
Emergency contraception is just one of a broad range of contraceptive options in use by teens today. In fact, teen births are at an all time low and research suggests that the decline is linked almost exclusively to a dramatic shift in teen contraceptive use. 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. Still, there is considerable room for improvement. The National Survey of Family Growth reports that nearly one in five female teens at risk of unintended pregnancy were not using any contraceptive method at last intercourse.
“In order for emergency contraception to be used as intended—in an emergency—we need to make sure teens have access to every tool in the pregnancy prevention toolbox. This means access to comprehensive, affordable reproductive health services, including emergency contraception and longer-term birth control. Through this surprising action the Obama administration has failed to break down a barrier to access for teens that was on track to be eliminated,” Rabinovitz said.
For more information on the California Family Health Council, visit www.cfhc.org.
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