Ob/gyn group issues statement on FDA's non-approval of OTC status for Plan B.

2004 JUN 3 - (NewsRx.com & NewsRx.net) -- The following is a statement issued May 7, 2004, by Vivian M. Dickerson, MD, president of the ACOG American College of Obstetricians and Gynecologists, regarding the decision by U.S. Food and Drug Administration officials not to approve over-the-counter status for Barr Research's emergency contraceptive (EC), Plan B.

The American College of Obstetricians and Gynecologists (ACOG) finds the U.S. Food and Drug Administration's failure to approve over-the-counter status for Plan B, despite the nearly unanimous recommendation of its own advisory panels, morally repugnant.

The Food and Drug Administration's (FDA) action is a tragedy for American women, and a dark stain on the reputation of an evidence-based agency like the FDA.

This decision to ignore an advisory panel's assessment of the scientific evidence is not only rare, but it gives credence to recent criticisms that political interference is hampering scientific review within federal agencies today.

In December 2003, two FDA expert advisory panels overwhelmingly recommended approval of the drug by a 23-to-4 vote, after reviewing more than 15,000 pages of clinical data from approximately 40 studies submitted with the over-the-counter (OTC) application. The FDA typically follows the recommendations of the scientific committees [Editor's note: the agency is not bound by the recommendations, however]. These experts made clear that EC is safe and that it does not increase promiscuity or unprotected sex among teenage women, nor does it cause women to abandon their regular birth control ...