December 01, 2006
FDA-Senate row reaches standoff over Ketek
The chairman of the Senate Finance Committee says the FDA’s acting commissioner is not complying fully with requests for information on the agency’s review of Sanofi-Aventis antibiotic Ketek.
Sen. Chares Grassley (R-Iowa) has been investigating the FDA’s handling of Ketek, which has been linked to reports of liver failure. The agency’s acting chief, Andrew von Eschenbach, has not produced the information sought, Grassley told Health and Human Services Secretary Mike Leavitt in a letter.
The letter stated that “at least three FDA officials, who played integral roles in the FDA's review of Ketek, were never asked to review their files and turn over relevant documents," Reuters reported.
Failure to comply with subpoenas sent by his committee is the reason for a hold the senator placed on von Eschenbach’s confirmation to head FDA, Grassley has said.
In a written response to the senator’s questions released this week, the acting commissioner said providing the information would comprise his agency’s independence. 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,” von Eschenbach wrote, according to the Associated Press.
A senior communications officer at FDA told MM&M that responding to Congressional inquiries is a "top priority for FDA" and that the agency has "worked diligently with 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."
The FDA is holding an advisory panel meeting on Dec. 14 and 15 to gather input from outside experts about whether Ketek should remain on the market.