The U.S. Department of Health and Human Services announced today that it is denying a request to expand access to over-the-counter emergency contraception to teenagers under 17.
The Associated Press reports that the FDA is considering whether to make over-the-county emergency contraception to teenagers younger than 17. Plan B, also known as the morning after pill, is currently available without a prescription to any woman 17 or older with a photo ID. Anyone younger than 17 needs a prescription. Reproductive rights advocates have long warned this type of restriction creates a longer wait time that is ill-advised for any woman seeking emergency contraception.
The AP reports:
Teva Pharmaceuticals wants its Plan B morning-after pill to become the first truly over-the-counter form of emergency contraception. The pill can prevent pregnancy if taken soon after unprotected sex.
…
Doctors’ and women’s health groups have long argued that the pill is safe even for younger teens and that lifting the age restriction would increase access for everyone. If the Food and Drug Administration agrees, Plan B One-Step could be moved from behind the counter to sell on drugstore shelves.
However, Health and Human Services Secretary Kathleen Sebelius announced that although “the science has confirmed the drug to be safe and effective with appropriate use,” she claims “the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. ”
“I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” she said in a statement today.
According to her statement:
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. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.
Reps. Diana DeGette, D-Col., and Louise Slaughter, D-N.Y., said in an op-ed for the Huffington Post earlier today, before the decision was announced, that this consideration by the FDA was an “exciting milestone for women’s health.”
