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. Clinton said the hold was intended to "draw a line" against "politicizing the FDA."
"This is a slippery, dangerous slope we are on, doctor, and we are looking to you to make a decision," Clinton told von Eschenbach.
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.
Sen. Edward Kennedy (news, bio, voting record) of Massachusetts, the panel's ranking Democrat, called the pending Plan B decision "a test case of FDA's integrity."
If Monday's announcement "leads to a swift and clear decision, I applaud it," Kennedy said, "but we must make certain that the administration does not use it as yet another delaying tactic."
Clinton raised the prospect that Bush might use a recess appointment to bypass the need for Senate confirmation. She asked the nominee if he would accept one before deciding on Plan B. Von Eschenbach responded that he wanted and looked forward to Senate confirmation.
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 risk of pregnancy by up to 89 percent.
Contraceptive advocates and doctors groups say easier access to Plan B could halve the nation's 3 million annual unintended pregnancies. Opponents say wider access to the pill could promote promiscuity.
The FDA's instructions to the manufacturer concerned over-the-counter sales to women. Cox, the Barr spokeswoman, said the question of whether men could purchase the drug on a woman's behalf had not been addressed.
Federal health officials thought that Monday's announcement about Plan B would smooth von Eschenbach's hearing. Instead, it subjected him to sometimes sharp questioning.
"Obviously, I think this brings the focus back on this arena," Susan Wood, the FDA's former top woman's health official, said before the hearing. Wood resigned last year to protest the FDA's refusal to loosen Plan B sales.
Von Eschenbach formerly led the University of Texas M.D. Anderson Cancer Center in Houston. Until recently, he was director of the National Cancer Institute, besides his role at FDA. The Philadelphia native has survived three cancer diagnoses: melanoma, prostate cancer and basal cell carcinoma.
The FDA has more than 12,000 employees and says it regulates nearly one in every four products that Americans consume.
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On the Net:
Food and Drug Administration: http://www.fda.gov/
Plan B: http://www.go2planb.com/ |
