The Food and Drug Administration will not be removing age restrictions for a morning-after birth control pill — a decision that's likely to prolong a fight that has raged for more than eight years.
In a statement today, FDA Commissioner Margaret Hamburg said she was convinced that the product, called Plan B One Step, is safe and effective at preventing pregnancy after unprotected intercourse for women of all ages. Currently the product is available without a prescription only to those age 17 and over. As long ago as 2003, two FDA advisory panels recommended the product be made available over the counter without age restrictions.
Hamburg, however, was overruled by her boss, Health and Human Services Secretary Kathleen Sebelius. As a result, the drug makers' application to remove the age restriction has been denied, and girls under age 17 will still need a prescription.
There will be more in the Shots blog.
"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age. ... Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application."