Andrew von Eschenbach can officially take the helm of FDA, following confirmation by the Senate Dec. 7.

His nomination to be FDA commissioner cleared the Senate by a comfortable 80-11 margin.

As a preliminary step, the Senate agreed 89-6 to invoke cloture on the nomination vote. The cloture decision, which requires a 60 percent majority, forces the Senate to limit debate and proceed to a vote despite "holds" against it.

Senate Health, Education, Labor and Pensions Committee Chairman Michael Enzi (R-Wyo.), whose panel has purview over FDA nominations, remarked after the cloture vote that "this is the second confirmation of an FDA director that we've worked on; it will be nice to have someone actually in the position."

The allusion is to Lester Crawford, who resigned in September 2005, two months after his confirmation as commissioner, and later pled guilty to conflict of interest and making false statements about stock holdings while at the agency (¹ Also see "Former FDA Commissioner Crawford Will Be Arraigned Oct. 17" - Pink Sheet, 16 October, 2006.).

Senate Finance Committee Chairman Charles Grassley (R-Iowa), who had a hold on the nomination, voted both against cloture and confirmation (² Also see "Senate May Take Up Von Eschenbach Nomination For Vote Thursday" - Pink Sheet, 6 December, 2006.).

During Senate floor debate, Grassley declared that he is "blowing the whistle" on von Eschenbach. The new commissioner has "failed to live up to his word" that he respects Congress as an equal power to the executive branch and has been "stonewalling" congressional oversight efforts, the senator said in an impassioned argument against approval.

Grassley has felt particularly stymied in his efforts to obtain documents and access to FDA line investigators to look into the approval and review of Ketek (telithromycin). The new drug application for the Sanofi-Aventis antibiotic has been subject to allegations of data integrity issues.

Grassley said he had hoped for at least "hints" that von Eschenbach might feel freer to provide the documents sought should he be installed as commissioner. The senator said he intends "to keep pressing the FDA for greater transparency."

Democratic Sen. Max Baucus (Mont.), who takes over the committee chairmanship in January, joined Grassley in voting against both the cloture motion and confirmation.

In a statement, von Eschenbach thanked Enzi, Sen. Ted Kennedy (D-Mass.) and outgoing Senate Majority Leader Bill Frist (R-Tenn.) for their support and counsel during the confirmation process.

- Denise Peterson (d.peterson@elsevier.com) & Steve Brown (s.brown@elsevier.com).

Von Eschenbach Nomination Clears Senate Handily

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