The American Academy of Pediatrics on Thursday released a policy statement supporting nonprescription sales of emergency contraception to teenagers and young adults, the AP/Belleville News Democrat reports (Johnson, AP/Belleville News Democrat, 9/1). The policy says that EC is safe and should not be confused with mifepristone as it does not have the ability to disrupt an embryo already implanted in the uterine lining (AAP policy statement, 9/2). The statement directs physicians to talk about the drug if they already are discussing sex with teenage patients, reminding them that they should be prepared to talk with patients about conflicting evidence on whether EC could disrupt implantation of a fertilized egg, as some patients could consider that an abortion (AP/Belleville News Democrat, 9/1). "Emergency contraception has tremendous potential to reduce unintended pregnancy rates in teens and adults," the statement said, adding, "The AAP continues to support improved availability of emergency contraception to teens and young adults, including over-the-counter access and limiting the barriers to access placed by some health care providers and venues" (AAP policy statement, 9/2). Wendy Wright, policy director of Concerned Women for America, said AAP should support getting doctors more involved in young patients' decisions, adding that they would be less involved if nonprescription EC sales were allowed. However, Jonathan Klein, chair of AAP's National Committee on Adolescence, said, "The evidence clearly supports that improving access to emergency contraceptives either decreases sexually transmitted diseases or has no effect on them."

Background
AAP last year endorsed a request for FDA to approve nonprescription sales of EC, but the new policy statement -- which will be published in the October issue of the journal Pediatrics -- is the first time the group has provided "detailed guidelines" on EC, according to the AP/News Democrat (AP/Belleville News Democrat, 9/1). FDA Commissioner Lester Crawford last week said the agency will indefinitely defer a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B and opened a 60-day public comment period on Barr's application. The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. Crawford at a press conference last week said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 9/1). In the policy statement, AAP said that both Plan B and Gynetics' EC Preven -- both FDA-approved for prescription sales -- are safe and effective for adolescent use, adding that Plan B is more effective and better tolerated than Preven (AAP release, 9/1). AAP said it is one of more than 60 medical and other groups signing a petition to the FDA stating that EC is "safe, efficacious and easy to administer," all of which are three factors required by FDA for nonprescription medications (AAP policy statement, 9/2). Groups opposed to EC accused AAP of making a political statement with the policy, but Klein denied the allegations (AP/Belleville News Democrat, 9/1).