Morning-after pill debate dogs nominee

Published August 2, 2006

WASHINGTON - Dr. Andrew von Eschenbach, nominated to head the Food and Drug Administration, said at his confirmation hearing Tuesday that "medical ideology" - not politics - guided his handling of proposed over-the-counter sales of the morning-after contraceptive.

Senators questioned von Eschenbach about the timing and substance of an FDA announcement that it would again consider expanding access to the emergency contraceptive known as Plan B. The announcement came Monday on the eve of the confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, and was the latest word in the three-year quest to widen access to the pill, made by Barr Pharmaceuticals Inc.

"We all know what's going on here," said Sen. Tom Harkin, D-Iowa, a committee member. "This is a disregard for science out of ideological concerns."

Von Eschenbach said he decided to consider allowing women 18 and older to buy the pills without a doctor's prescription "not on a political ideology, but on a medical ideology." He said data did not support safe over-the-counter use by minors.

"No one told me what I should or could do. No one told me what decision I must and must not take," von Eschenbach said during questioning.

The FDA has been without a permanent leader for all but 18 months since Bush took office in 2001. Von Eschenbach has led the agency on an acting basis since September.

"Without a Senate-confirmed leader, we can't expect the FDA to be as effective as it can be," said committee chairman Mike Enzi, R-Wyo.

The committee did not vote on von Eschenbach's nomination.

Sens. Hillary Clinton, D-N.Y., and Patty Murray, D-Wash., have placed a hold on the nomination until the FDA makes a final decision on the emergency contraceptive.

Von Eschenbach said the timing of a decision on Plan B depended on Barr. Later, Barr spokeswoman Carol Cox said there was no word on when the company and FDA would even meet. FDA spokeswoman Susan Bro said the agency expects to meet with the company on Monday.

The FDA told Barr on Monday that it should further amend its application to limit over-the-counter sales to women 18 and older and create separate packaging to distinguish prescription and nonprescription versions of the pills. The FDA also wants to discuss Barr's plans to restrict distribution to certain pharmacies. It sought a meeting within seven days.

Von Eschenbach told the panel that under his leadership, the agency would be guided by sound science and that he was "committed to maintaining the long-standing traditions and values" at the FDA.

Plan B was approved for prescription use in 1999. Since 2003, the Women's Capital Corp. and then Barr have sought to sell it over-the-counter.

The morning-after pill is a high dose of the most common ingredient in regular birth control pills.

When taken within 72 hours of unprotected sex, the two-pill series can lower the chance of pregnancy by as much as 89 percent.