As you likely read in the news today, Health and Human Services Secretary Kathleen Sebelius reversed a U.S. Food and Drug Administration decision to lift an age limit on the Plan B One-Step emergency contraceptive and allow girls 16 years old and younger to purchase it over-the-counter. The decision has angered women's health advocates and some physician groups who said the secretary's actions is a "profound disappointment for the health of adolescent girls and is inconsistent with what we know about the safety and benefits of emergency contraception."
Paula Hillard, MD, professor of obstetrics and gynecology at Stanford, was among the doctors who expressed her deep disappointment at the news. In a Medpage Today article, Hillard said she was "outraged." She continued:
There is no evidence of harm to adolescents, and no physiologic or medical reason that [Plan B] should be made more difficult for teens to access than for adults. In fact, given the national shame of the U.S. having the highest rates of adolescent pregnancy in the developed world, there are many reasons to make Plan B more accessible to teens.
Sebelius said in a statement:
The science has confirmed the drug to be safe and effective with appropriate use. However, 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 Women's Health Inc.'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.