Secretary of Health Kathleen Sebelius has overturned a decision by the Food and Drug Administration (FDA) that would have allowed the emergency contraceptive, or "morning after pill," Plan B One-Step, to be sold to women 16 years and younger without a prescription.
Plan B One-Step is currently approved for sale over-the-counter to women 17 and older, and by prescription only to women 16 and younger. However, in Feb. 2011, the makers of Plan B One-Step, Teva Women's Health Inc., applied to the FDA for permission to make the drug available for sale over the counter to all women of "reproductive age." Finding the drug to be safe and effective with appropriate use, the FDA approved Teva's application.
However, in a December 7, 2011 letter to Commissioner of Food and Drugs Margaret Hamburg, M.D., Sec. Sebelius informed the FDA that she was overturning its decision based on her belief that girls of younger child bearing ages might not be capable of fully understanding Plan B One-Step's labeling and instructions, and the implications of its use.
Existing FDA regulations requiring that makers of drugs approved for over-the-counter sale prove that persons of all ages who might use the medicine can understand the label and use the product appropriately. "I do not believe that Teva's application met that standard," stated Sec. Sebelius in her letter to the FDA. "The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."
Sebelius cited data showing that the average age of the onset of menstruation for girls in the United States is 12.4 years, but that about 10% of girls as young as 11.1 years are physically capable of bearing children.
"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," wrote Sec. Sebelius. "If the application were approved, the product would be available, without prescription, for all 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," wrote Sebelius.
Plan B One-Step will remain available over the counter to women ages 17 and older.
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