Washington Editor

WASHINGTON - Acting FDA Commissioner Andrew von Eschenbach is likely to clear an eventual vote in the Senate Health, Education, Labor and Pensions Committee, according to Chairman Mike Enzi (R-Wyo.), but his nomination before the entire chamber body still faces the Plan B hurdle.

That's because Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) are continuing their hold on the confirmation process, a block that has arisen out of the agency's indecision on whether to allow over-the-counter sales of the so-called "morning after pill." But their formal opposition does not apply to a verdict by the committee, which on Tuesday held a hearing on von Eschenbach and will meet again next month, perhaps for a vote.

Von Eschenbach, President Bush's selection for the position since last fall, must first secure the committee's backing before his nomination reaches the Senate floor. Clinton and Murray used the hearing to press the nominee on his plan for deciding on Plan B, as did several of their colleagues. At present, the emergency contraceptive product is available only with a prescription.

Calling the FDA "a political football," Clinton warned von Eschenbach that he was "on the field." She echoed the comments of several committee members in cautioning against the politicization of the agency. "This is a slippery, dangerous slope," she said.

Along the same lines, Murray noted that continuing Plan B wavering is "symbolic" of a growing public "crisis of confidence" in the FDA. In short, she charged that the agency's lack of a decision is undermining its reputation.

"We have seen an agency that's in trouble," said Ranking Member Ted Kennedy (D-Mass.), advising against "unfair pressures to ignore science."

But von Eschenbach repeatedly asserted his support for the FDA's past decisions on the product, most of which were made well before his tenure. Initially the agency rejected an application to make it available without a prescription to all females; more recent indecision has centered on restricting over-the-counter sales to certain age groups.

Just this week, von Eschenbach told Plan B's maker, Duramed Pharmaceuticals Inc., that the agency would consider non-prescription status for women 18 and older. That determination was made partly from a review of more than 47,000 public comments that were submitted to the FDA about its review. The company's parent firm, Woodcliff Lake, N.J.-based Barr Pharmaceuticals Inc., had amended its original application for over-the-counter sales to those 16 and older. (See BioWorld Today, Aug. 1, 2006.)

The challenge in this review and others, von Eschenbach told committee members, lies in defining a "correct balance between protecting and promoting public health." That risk-vs.-benefit principle, he added, underscored the agency's recent decision to again allow sales of the multiple sclerosis drug Tysabri (natalizumab, from Biogen Idec Inc. and Elan Pharmaceutical Corp. plc), despite its known safety concerns.

The same standard, von Eschenbach assured committee members, would apply to all future decisions.

Several senators pointed to recent polls showing internal dissatisfaction and low morale at the FDA, a discontent owing in part to allegedly inappropriate influences on scientific reviews by the agency's management and by the drug industry. But von Eschenbach promised that a culture of open scientific debate would be encouraged inside the FDA, in addition to noting efforts at further transparency for public watchers. (See BioWorld Today, July 24, 2006.)

He declined to respond to a question about a rumored recess appointment by President Bush, which would be timed during this month's customary break in the congressional calendar. That would circumvent the committee process and a subsequent vote before the full Senate.

The president nominated von Eschenbach following last fall's resignation of Lester Crawford, who served as both its acting and permanent commissioner. A Plan B decision was promised during Crawford's nomination proceedings but was not fulfilled, leading to Clinton and Murray's vocal dissatisfaction with the matter this summer. (See BioWorld Today, Sept. 27, 2005, and Oct. 6, 2005.)

Among von Eschenbach supporters at the standing-room-only hearing were four members of the FDA's top brass. Also in attendance was Susan Wood, a former agency official who resigned last year in protest of the Plan B matter.

The FDA has had a Senate-confirmed FDA commissioner for just 18 months in the past five years. Von Eschenbach, who generally is viewed as friendly to the drug industry, had been serving as the director of the National Cancer Institute before his FDA nomination. A cancer survivor himself, he previously enjoyed a lengthy tenure at the University of Texas M. D. Anderson Cancer Center in Houston, and was in line to head the American Cancer Society until moving into the public sector.

No committee member questioned those credentials, Enzi noted, and von Eschenbach indicated his desire to be judged on that record.