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HHS Secretary Sibelius in 2011 [all bolding mine]:
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. ...Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.
A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius
From LifeNews:
Jeanne Monahan, Director of Family Research Council’s Center for Human Dignity, told LifeNews after the decision: “A decision to make Plan B available for girls under the age of 17 without a prescription would not have been in the interest of young women’s health. Secretary Kathleen Sebelius was right to reject the FDA recommendation to make this potent drug available over the counter to young girls. In her own words, the research submitted to the FDA did not include data for all ages for which the drug would be used.”
“Additionally, young people have approximately half of the sexually transmitted diseases (STDs) nationwide, according to the Center for Disease Control and Prevention (CDC). The availability of Plan B over-the-counter for all ages would have bypassed necessary routine medical care for sexually active girls. And a study released in 2010 revealed that adolescent use of Plan B was correlated with an increase in unplanned pregnancies and a high STD rate,” she said.
Justice Department Appeals FDA Ruling Selling Plan B Pill to Teens | LifeNews.com
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. ...Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.
A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius
From LifeNews:
Jeanne Monahan, Director of Family Research Council’s Center for Human Dignity, told LifeNews after the decision: “A decision to make Plan B available for girls under the age of 17 without a prescription would not have been in the interest of young women’s health. Secretary Kathleen Sebelius was right to reject the FDA recommendation to make this potent drug available over the counter to young girls. In her own words, the research submitted to the FDA did not include data for all ages for which the drug would be used.”
“Additionally, young people have approximately half of the sexually transmitted diseases (STDs) nationwide, according to the Center for Disease Control and Prevention (CDC). The availability of Plan B over-the-counter for all ages would have bypassed necessary routine medical care for sexually active girls. And a study released in 2010 revealed that adolescent use of Plan B was correlated with an increase in unplanned pregnancies and a high STD rate,” she said.
Justice Department Appeals FDA Ruling Selling Plan B Pill to Teens | LifeNews.com
