"Plan B" flap leaves FDA nominee in limbo

Washington -- Controversy surrounding federal handling of the application for over-the-counter status of the emergency contraceptive pill known as Plan B landed Acting Food and Drug Administration Commissioner Andrew C. von Eschenbach, MD, in hot water during a Senate hearing over his nomination to permanently fill the post.

The FDA on July 31 announced a "framework" to speed approval of the OTC status of the emergency contraceptive, which was recommended nearly three years ago by the agency's advisory committee. Several groups, including the AMA, have urged forward movement on OTC approval since then.

Despite the new framework, Dr. von Eschenbach's status remained unchanged after the Aug. 1 hearing. Sens. Hillary Rodham Clinton (D, N.Y.) and Patty Murray (D, Wash.), proponents for the drug's OTC availability, placed a hold on the nominee's approval last spring until the FDA made a decision on levonorgestrel. Both said after the hearing that the hold would remain in place because the agency provided no timeline for action.

Although the FDA said approval under its new framework could come in a matter of weeks, a similar promise was made by former FDA Commissioner Lester M. Crawford, DVM, PhD, at his confirmation hearing last summer. Dr. Crawford left the agency soon after.

The AMA adopted policy in 2004 urging the FDA to move forward with OTC status for the contraceptive. Until that happens, the Association encourages physicians to write advance prescriptions for patients. Plan B must be taken within 72 hours of intercourse to be effective.

Clinton and other Democratic senators also grilled Dr. von Eschenbach about Bush administration actions that they view as politicizing a scientific agency. "This is a dangerous, slippery slope we're on, doctor, and we're looking to you to get a decision made," said Clinton.

Despite the Senate hold, some predict that President Bush may appoint his nominee to the post during Congress' August recess.