One of Andrew von Eschenbach's first major steps as FDA commissioner is likely to be release of the agency task force response to the Institute of Medicine's recommendations to improve drug safety oversight.

Von Eschenbach can delete "acting" from his office name plate: the Senate confirmed him Dec. 7 by an 80-11 margin.

He has a number of pending items on his desk, such as securing resources to implement the Critical Path Initiative, but the release of the task force recommendations are likely to be one of the first significant actions bringing von Eschenbach into the limelight as commissioner. It may shape the tone and priorities of his tenure as commissioner.

The recommendations, being drafted by an Office of the Commissioner office-level task force, are expected for release later in December (¹ Also see "Gottlieb’s New Year’s Wish List: Risk Management Plans Out, Science In" - Pink Sheet, 20 November, 2006., p. 3).

The effort, which draws upon several working groups from various FDA medical centers, will evaluate the reforms recommended by the IOM Assessment of the U.S. Drug Safety System, determining which might be adopted in the near term and which require additional time for review and implementation. IOM's sweeping report addresses issues ranging from FDA organizational culture, modifications to the drug review process, enhanced agency leadership, and bolstered resources and funding.

The recommendations are likely as well to draw close scrutiny on Capitol Hill, not only from the Senate Health Committee, which has legislative jurisdiction over FDA, but also from perhaps von Eschenbach's most vocal critic, Senate Finance Committee Chairman Charles Grassley (R-Iowa).

Grassley had placed a "hold" against a vote on the nomination, largely due to objections that FDA had not provided documents and access to line investigators related to the approval and review of Sanofi-Aventis' antibiotic Ketek (telithromycin). But Grassley also posed questions about von Eschenbach's perspective on the IOM report (² Also see "Separate Safety Center Could Impair Oversight “Continuity” - Von Eschenbach" - Pink Sheet, 4 December, 2006., p. 15).

To get to the confirmation vote, the Senate first invoked cloture by 89-6. A cloture motion, which requires passage by 60 percent, limits debate and forces a Senate vote. It has the impact of cutting off filibusters and overturning holds.

Grassley made a vociferous address to the Senate opposing both the cloture amendment and von Eschenbach's confirmation, declaring FDA has not provided "transparency" in its actions and has disrespected Congress' oversight role.

The Iowa senator took advantage of a lull in Senate action to return to the floor and issue further salvos. Grassley urged his Senate colleagues to read IOM's criticisms of FDA. Von Eschenbach is "not the person for the job" of meeting the challenges outlined by IOM, Grassley said.

Despite its lack of legislative purview, the Finance Committee is likely to remain a tough forum for von Eschenbach. Sen. Max Baucus (Mont.), who will take the Finance Committee chairmanship when Congress convenes in January, also voted against the cloture motion and confirmation. He was the only Democrat to do so.

Other senators opposing confirmation, all Republicans, were Sam Brownback (Kan.) Jim DeMint (S.C.), Mike DeWine (Ohio), James Inhofe (Okla.) Rick Santorum (Penn.), James Talent (Mo.), David Vitter (La.), and George Voinovich (Ohio).

Vitter and DeMint had placed earlier holds on the vote; Vitter's regarded drug importation and DeMint's related Danco Laboratories' abortifacient Mifeprex (mifepristone).

In a statement issued upon his confirmation, von Eschenbach said: "I am humbled by the responsibility with which I have been entrusted and the covenant to protect and promote the health of the American people. As we face increasingly complex scientific, medical and regulatory issues, I am committed to leading this agency in a manner that continues to earn their trust and respect."

Von Eschenbach is taking the permanent reins after nearly nine months as the nominee and over a year as the acting commissioner of FDA. His confirmation took nearly twice as long as that of his predecessor, Lester Crawford, but he won confirmation with fewer "no" votes. Crawford garnered 16 nays to the 11 cast against von Eschenbach (³ Also see "Crawford’s First Business After Confirmation: Brief Senators On Mifeprex" - Pink Sheet, 25 July, 2005., p. 4).

- Denise Peterson

Von Eschenbach’s Commissioner Debut May Be Release Of Safety Report

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