FDA, lawmaker clash over antibiotic

[Ron Burgundy]

AP - President Bush's choice to head the Food and Drug Administration is refusing to give Congress all the information it seeks about a controversial antibiotic, setting up further confrontations with a Republican senator blocking his nomination.

The agency's acting chief, Dr. Andrew von Eschenbach, said full disclosure of the information about Ketek could have a chilling effect on the FDA's ability to be an independent and objective evaluator of drug safety and other issues.

The statement came in a written response to questions by Sen. Charles Grassley (news, bio, voting record), R-Iowa. Grassley is blocking Senate confirmation of von Eschenbach while he investigates the FDA's handling of Ketek, which has been linked to severe liver problems and several deaths.

"Selectively providing documents and access to executive agency officials pursuant to a congressional subpoena cannot constitute compliance," Grassley wrote Health and Human Services Secretary Mike Leavitt on Wednesday.

The letter was released Thursday; the FDA is part of HHS.

Von Eschenbach wrote that "the disclosure of information that might relate to any open investigation in response to congressional inquiries poses an inherent threat to the integrity of the executive branch's enforcement and litigation functions."

On Thursday, FDA spokeswoman Kristen Neese said the agency had worked since April to provide Grassley's staff "access to as much data and as many agency personnel as possible, while remaining responsible stewards of the extraordinarily sensitive information we handle."

Grassley said he would continue to block von Eschenbach's confirmation due to "resistance from the FDA and the Department of Health and Human Services to congressional oversight."

"The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government," Grassley said.

Ketek is made by the French pharmaceutical company Sanofi-Aventis SA.