Washington Editor

WASHINGTON - Just ahead of a Senate committee hearing on Acting FDA Commissioner Andrew von Eschenbach, the agency appears to be budging on a matter that has held up his nomination - Plan B.

The agency's heretofore reticence to decide on allowing over-the-counter sales of the so-called "morning after pill" has led Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) to hold up the confirmation process. But on Monday, the FDA said it would meet immediately with the product's manufacturer, Duramed Pharmaceuticals Inc., to discuss the approvability of an amended application and the framework by which the emergency contraception might be made available over the counter.

At present, Plan B is available only with a prescription. The FDA has told Duramed, a subsidiary of Woodcliff Lake, N.J.-based Barr Pharmaceuticals Inc., that it plans to move the product from prescription only to over-the-counter status for women 18 and older. Barr had applied for non-prescription sales to those 16 and older.

The Senate Health, Education, Labor and Pensions Committee scheduled a hearing with von Eschenbach today, although no vote on his nomination was expected. A joint statement issued by Clinton and Murray said they would continue to block von Eschenbach until a decision is made, calling the "11th hour announcement" from the FDA "far from a yes-or-no decision" on Plan B.

Speculation has arisen of late that President Bush might make a recess appointment of von Eschenbach during this month's traditional downtime in Washington, when Congress officially goes on break, circumventing the committee process and a subsequent vote before the full Senate. The president nominated von Eschenbach for the position last fall following the resignation of Lester Crawford, who endured a contentious tenure atop the FDA as both its acting and permanent commissioner. (See BioWorld Today, Sept. 27, 2005, and Oct. 6, 2005.)

A Plan B decision was promised during his nomination proceedings, but went unfulfilled.

Von Eschenbach, who is generally viewed as friendly to the drug industry, had been serving as the director of the National Cancer Institute before his FDA nomination.