Morning-after pill entangles Bush's FDA nominee
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01/Aug/2006 11:07AM

WASHINGTON (AP) -- President Bush's nominee to lead the Food and Drug Administration said Tuesday that "sound science" would guide the agency under his leadership. But Dr. Andrew von Eschenbach initially sidestepped any mention of the controversial morning-after pill.

Von Eschenbach told his Senate confirmation hearing in his opening remarks that he was "committed to maintaining the long-standing traditions and values" of the regulatory agency, which has come under fire from some congressional quarters for alleged foot-dragging on approval of the emergency contraceptive pill.

Federal health officials thought that Monday's surprise announcement that the agency was again considering allowing over-the-counter sales of the pill -- also known as "Plan B" -- would smooth von Eschenbach's hearing. But there were early signs that just the opposite effect was in play.

"Obviously, I think this brings the focus back on this arena," Susan Wood, the FDA's former top woman's health official, told The Associated Press before the hearing. Wood resigned last year to protest the FDA's refusal to approve the medication.

Lawmakers are questioning both the timing and sincerity of the FDA's announcement Monday that it would again consider allowing the pills to be sold to adult women without a prescription.

Two of the senators on the panel renewed their vow to block his nomination until the FDA made a final decision on whether to allow Barr Pharmaceuticals Inc. to sell Plan B over the counter to women 18 and older. Minors would still need a doctor's prescription.

Sens. Patty Murray, D-Washington, and Hillary Rodham Clinton, D-New York., had placed a similar hold on von Eschenbach's predecessor, Lester Crawford.

They removed that hold more than a year ago in exchange for a pledge that the FDA would act on Barr's application. Crawford won Senate confirmation but then put off a decision on Plan B, earning the enmity of the two lawmakers.

"Fool me once. We are not going to go there again. We will hold this nomination until we have a decision on Plan B," said Murray, calling the timing of Monday's announcement "highly suspect behavior."

Crawford resigned abruptly in September 2005 only two months after the Senate confirmed him to run the agency. Von Eschenbach has been acting FDA commissioner since then. In March, President Bush nominated the urology surgeon to lead the regulatory agency on a full-time basis.

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.

Since 2003, the Women's Capital Corp. and then Barr have sought to loosen the prescription-only restriction on Plan B.

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 own scientists say the pills are safe, and in December 2003 a panel of independent advisers overwhelmingly backed nonprescription sales for all ages.

The FDA rejected that recommendation, citing concern that young teens could use the pills without a doctor's supervision. Barr initially had sought approval for over-the-counter sales without age restrictions, but later amended its application to ask for permission to sell to females 16 and older.

In a letter sent Monday to Barr, von Eschenbach said the company should further amend it to limit sales to women 18 and older and create separate packaging to distinguish over-the-counter and prescription versions of the pills. The FDA also wants to discuss Barr's plans to restrict distribution to certain pharmacies.

"There is no timeline in any statement FDA put out. There is no hint the FDA is any closer to a decision," Clinton said.

Von Eschenbach has been chief academic officer of the University of M.D. Anderson Cancer Center in Houston, Texas, and director of the National Cancer Institute. The Philadelphia native has survived three cancer diagnoses: melanoma, prostate cancer and basal cell carcinoma.




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