Medical groups applauded Fridays ruling by a U.S. District Court judge that requires the Food and Drug Administration to remove age restrictions for over-the-counter access to Plan B One-Step, an emergency contraception product.
The decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age, according to a news release from the American Academy of Pediatrics.
Emergency contraception use can reduce the risk of pregnancy up to 120 hours after unprotected intercourse or contraceptive failure, and is most effective if used within the first 24 hours. Prior to the policy change required by Fridays court ruling, teens under 17 had to obtain a prescription from a healthcare provider to access all forms of emergency contraception.
“Unintended pregnancies pose a significant risk to the physical and emotional health of adolescents,” AAP President Thomas K. McInerny, MD, FAAP, said in the news release. “While pediatricians recommend that teens delay sexual activity until they fully understand its consequences, we strongly encourage the use of contraception — including emergency contraception — to protect the health of our adolescent patients who are sexually active.”
The Society of Adolescent Health and Medicine and the American College of Obstetricians and Gynecologists also praised the ruling.
“EC is a safe, effective way to help prevent unintended pregnancy after a contraceptive failure, unprotected sex or sexual assault,” said James. T Breeden, MD, president of the ACOG. “We believe all EC products should be available over the counter.”
“Removing the age restriction is a positive step forward, but providers must continue efforts to educate adolescents about the proper use of emergency contraception,” said Debra Katzman, MD, president of the SAHM. “We must also work to ensure that emergency contraception is available for adolescents of limited means.”
The FDA previously agreed to make emergency contraception available over the counter to women and girls of all ages. But Kathleen Sebelius, secretary of the Department of Health and Human Services, overruled the FDAs decision in December 2011.
Thus stores have had to keep the product behind the pharmacy counter but allow women and girls ages 17 and older to buy it without restriction.
“The science has confirmed the drug to be safe and effective,” Sebelius said at the time. “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.”
A link to the court ruling is available at www.nyed.uscourts.gov/news/memorandum-and-order-12-cv-273-tummino-et-al-v-hamburg-et-al.