- The Washington Times - Tuesday, August 1, 2006


The acting head of the Food and Drug Administration yesterday told his confirmation hearing that his decision to revive consideration of over-the-counter sales of the morning-after pill was based on science, not politics.

Dr. Andrew von Eschenbach, President Bush’s nominee to head the agency, was hammered by senators about the timing of Monday’s FDA announcement about the emergency contraceptive pill and why a decision was delayed for so long.

“We all know what’s going on here. This is a disregard for science out of ideological concerns,” said Sen. Tom Harkin, Iowa Democrat.

Dr. von Eschenbach said he made the decision to consider allowing greater access to the pills to women 18 and older “not on a political ideology, but on a medical ideology.” He said data did not support the safe over-the-counter use by minors.

Federal health officials thought that Monday’s surprise announcement about the pill, known as “Plan B,” would smooth Dr. von Eschenbach’s hearing. Instead, he faced sharp questioning from members of the Senate Health, Education, Labor and Pensions Committee.

Sen. Hillary Rodham Clinton, New York Democrat, who has put a hold on Dr. von Eschenbach’s nomination until the FDA makes a final decision on the pill, said the move 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,” she said.

Sen. Edward M. Kennedy 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,” Mr. Kennedy said, “but we must make certain that the administration does not use it as yet another delaying tactic.”

Earlier, Dr. 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” of the regulatory agency, which has come under fire from some congressional quarters for purported intentional delays on approval of the emergency contraceptive pill.

Mrs. Clinton and Sen. Patty Murray, Washington Democrat, renewed their vow to block Dr. von Eschenbach’s 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.

Dr. von Eschenbach has been acting FDA commissioner since Dr. Lester M. Crawford resigned abruptly in September, two months after the Senate confirmed him to run the agency. After Dr. Crawford cleared confirmation, he put off a decision on approval of Plan B, thus earning the enmity of Mrs. Clinton and Mrs. Murray.

In March, Mr. Bush nominated Dr. von Eschenbach, a 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.

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.

FDA 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 younger 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 women and girls 16 and older.

Dr. von Eschenbach has been chief academic officer of the University of Texas M.D. Anderson Cancer Center in Houston 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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