Senator accuses FDA nominee of withholding information

Senate Finance Chairman Charles Grassley, R-Iowa, is accusing acting Food and Drug Administration Commissioner Andrew von Eschenbach of failing to defer to congressional oversight, further complicating his bid to head the agency.

This latest confrontation was prompted by von Eschenbach's written responses to questions submitted by Grassley during a Senate confirmation hearing. Grassley released those responses Thursday along with a critical statement: "The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government."

Specifically, Grassley accused von Eschenbach of failing to cooperate with the committee's investigation of the antibiotic Ketek. The investigation was sparked by allegations that the drug was approved by the FDA despite evidence that some clinical safety data was fraudulent.

In his response to a question about the agency's failure to cooperate with the investigation, von Eschenbach wrote that "disclosure of pre-decisional information would significantly compromise the ability of our staff to consider important public health and safety matters in an objective and independent setting."

Grassley also released a letter sent Wednesday to Health and Human Services Secretary Michael Leavitt, accusing the FDA and HHS of failing to provide all information requested by the committee.

"Selectively providing documents and access to executive agency officials pursuant to a Congressional subpoena cannot constitute compliance," Grassley wrote, noting that some relevant documents had been "'overlooked' or purposefully withheld."

Grassley requested a complete list of officials involved in the review or post-market surveillance of Ketek by Dec. 13. In an e-mailed statement, an FDA spokeswoman said, "We have worked diligently w/ Sen. Grassley's staff since April to provide them access to as much data and as many Agency personnel as possible, while remaining responsible stewards of the extraordinarily sensitive information we handle, as a regulatory agency in the Executive Branch."

Grassley announced his intention to block a Senate vote on von Eschenbach's nomination in a Nov. 16 letter to Majority Leader Bill Frist, R-Tenn., because of his "continued failure to comply with the Committee's subpoenas over the past six months."

A spokeswoman for Finance ranking member Max Baucus, D-Mont., who will become chairman in January, declined to comment on Grassley's criticisms of the nominee. Von Eschenbach, who was nominated to the position in March, faces additional hurdles to his confirmation.

Sens. David Vitter, R-La., and Jim DeMint, R-S.C., also have expressed their intentions to put a hold on the nomination. Vitter wants the FDA to legalize the importation of personal shipments of prescription drugs from Canada. DeMint said he objects to the sale of RU-486.

Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., lifted their early objections to von Eschenbach's confirmation in late August after the FDA agreed to allow over-the-counter sale of Plan B to women age 18 or older. The Health, Education, Labor and Pensions Committee approved Von Eschenbach's nomination by voice vote in September.

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