Washington Editor

WASHINGTON - Acting FDA Commissioner Andrew von Eschenbach's nomination cleared a significant hurdle Wednesday, with a unanimous vote from the Senate Health, Education, Labor and Pensions (HELP) Committee, but his path to confirmation still faces roadblocks.

Two new holds have been placed on the nomination, this time from GOP senators, weeks after two longstanding Democrat holds were lifted. In the latest procedural blocks, Sen. Jim DeMint (R-S.C.) is holding up the nomination in an attempt to get the FDA to rescind its approval of the abortion drug RU-486, and Sen. David Vitter (R-La.) is using the same tactic to secure drug imports from Canada.

Calling the FDA's top spot "a very difficult position for anyone to hold," committee Chairman Mike Enzi (R-Wyo.) noted that clearing this confirmation process "has to be the toughest thing outside a Supreme Court justice to get passed around here."

The nature of the position, he continued, has become a Catch-22. Of note, the FDA has had a confirmed commissioner for only 18 months in the last five and a half years.

Clearly, that's due in part to myriad political forces seeking to pull strings at the agency. Enzi stressed that FDA policies should be based upon science, not politics, a cry that's been heard over and over again during von Eschenbach's nomination and also that of his predecessor, Lester Crawford.

"If we move away from basing this thing on science," Enzi cautioned, "it just becomes more of a political football than it has been."

The committee's voice vote in support of von Eschenbach was held in the president's room at the Capitol, just off the Senate floor, where the lawmakers have been gathering en masse to urgently move on various legislative matters. Noting the near-term horizon for this congressional session - both chambers are going on recess after next week in advance of the coming mid-term elections - Enzi indicated that he would push for a full Senate vote "as soon as we have a chance."

But first the full Senate has a chance to raise objections to von Eschenbach's nomination, now that it's cleared the committee, and this is the point where the holds come into play. A filibuster-like procedure, a hold can be used to stymie a nomination or a bill. In the Senate, 60 votes are required to overcome holds. Traditionally, they are filed anonymously, although that hasn't been the case with this nomination.

DeMint, in voicing his continued opposition, said in a statement that von Eschenbach "has done nothing to publicly discourage the use of" RU-486, a product he linked to eight deaths and more than 1,000 adverse events in recent years. "In the face of mounting scientific evidence, injury and death, the FDA has done nothing to suspend this drug and prevent it from hurting or killing more women," which he said calls into question "its ability to protect American consumers."

Calls to Vitter's office were not returned.

Enzi said he would work with DeMint, Vitter and any other Republicans "to see what their concerns are," though he said there might not be any issues "now that we got through committee." Its ranking member, Sen. Ted Kennedy (D-Mass.), would handle any Democrat objections.

Less than a month ago, holds from Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) were lifted after the FDA approved over-the-counter sales of the Plan B contraceptive product to women 18 and older.

With the coming break in congressional business, there remains the possibility of a recess appointment for von Eschenbach. But Enzi indicated that such an appointment would put the FDA in a position of weakness, especially relative to negotiating bills to reform the agency, as would von Eschenbach's continued acting status. Sen. Barbara Mikulski (D-Md.) added that FDA needs "vigorous oversight" to ensure that the agency "stays true" to its mission.

The drug industry has staunchly stood behind von Eschenbach, who first came to the FDA a year ago following Crawford's abrupt resignation just months after receiving Senate confirmation himself. Previously, von Eschenbach led the National Cancer Institute. (See BioWorld Today, Sept. 27, 2005.)

Enzi, whose committee vetted von Eschenbach's nomination last month, said, "We're not going to get somebody better qualified than this man."