PLAN B SHOULD BE OVER-THE-COUNTER FOR ADOLESCENTS
Safety data adequate

Washington, DC---The American Academy of Pediatrics (AAP) and the Society for Adolescent Medicine (SAM) sent a letter yesterday to the Food and Drug Administration (FDA) and Barr Research, Inc., calling on the federal agency to reconsider its decision on Plan B, an emergency contraceptive, and allow it to be distributed over-the-counter (OTC) to women and sexually active adolescents. There is adequate safety information for the drug to be used by adolescents, and it is needed to prevent teenage pregnancy, according to the two organizations.

The AAP and SAM strongly disagree with the FDA decision on May 7 rejecting Barr Research's request to make Plan B OTC. The agency cited a lack of safety data in adolescents, particularly the 14 - 16 age range.

"We believe FDA reached an erroneous conclusion when it determined that there is not adequate data to support the safe use of Plan B by young adolescent women…" the May 26 letter states. "There is adequate safety information about the use of emergency contraceptives both from Barr Research Inc.'s supplemental new drug application and data associated with long-term prescription use of these agents in the adolescent population. Approximately one-fifth of the participants in the Barr trials were between the ages of 14-16, which represents ages below or consistent with the average age of first intercourse."

If the medicine is ultimately approved as OTC, the organizations also urged that the product label have a statement instructing the individual to contact a physician or other health care professional after using the product.

"Excluding adolescents from having OTC access to Plan B sets a dangerous precedent for adolescent health," states the letter. "Sexually active adolescents should not have barriers to access reproductive health care."

While health professionals encourage abstinence in adolescence as the surest way to prevent sexually transmitted diseases and pregnancy, some teenagers do have sex. Using contraception correctly and having emergency contraception available is key to preventing pregnancy. Contrary to some claims, having emergency contraception available does not increase sexual activity among adolescents, according to recent research.

AAP and SAM called for Plan B OTC status in February comments to the federal government as well.

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The American Academy of Pediatrics is an organization of 57,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well being of infants, children, adolescents and young adults.

The Society for Adolescent Medicine is a multidisciplinary organization of 1,400 health professionals who care for adolescents.