Adolescents can successfully use over-the-counter Plan B One-Step

Unintended pregnancy is elevated among teens in the United States and is far more common than in other developed countries. Emergency contraceptive pills, like Plan B One-Step, provide effective pregnancy prevention but females under age 17 must have a prescription to purchase them. The pills are most effective when taken promptly, so waiting for a clinic to open after the weekend can mean higher failure rates. The U.S. Food and Drug administration recently considered several studies on levonorgestrel emergency contraception among females under 17, and decided that adolescents could safely use the product without a prescription.

One of the studies the FDA considered was from UCSF Bixby Center researchers, Drs. Tina Raine and Cynthia Harper, and has now been published in Obstetrics & Gynecology. The study shows that females younger than 17 can read Plan B One-Step’s label and understand whether or not to use it, and then use it correctly, in over-the-counter conditions. The study included females aged 13-17, and found no differences in their ability to choose or use Plan B by age.

In an unprecedented move, the U.S. Department of Health and Human Services Secretary Kathleen Sebelius overturned the FDA decision. Secretary Sebelius objected to the fact that there are no data on whether 11 and 12-year olds can safely use the product. There are no data about such young girls because their need for emergency contraception is exceedingly rare. Secretary Sebelius’ decision, however, means that 15 and 16 year olds, who may be sexually active and need access to emergency contraception, may not get it in time to prevent pregnancy. Adult women as well must still wait for pharmacy hours to obtain the product when needed since it will remain behind the counter. In response to the situation, Dr. Harper commented, “We need to direct our policy efforts toward reducing unintended pregnancy, so that teens and young women in this country have the opportunity to complete their education, to contribute to the labor force and to take proper care of the children they do have.”