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A United States senator is accusing the Food and Drug Administration of attempting to cover up information pertaining to its review of the controversial antibiotic Ketek .

The Senate Finance Committee, led by Republican Charles Grassley, is currently reviewing the FDA''s approval of Ketek and the monitoring of the drug''s safety.

Grassley said he smelled a “cover-up” after the agency refused to make available one of its criminal investigators who earlier had conducted a probe into allegations of fraud surrounding the drug.

The FDA said the investigator was not available because the probe is ongoing and might compromise the investigation.

The senator addressed reporters yesterday after meeting with FDA officials at the Department of Health and Human Services headquarters. It was the first time he had personally visited a federal agency to make a demand since 1983, he said.

“This is very extraordinary for me to do this. We are tired of the run-around,” Grassley told reporters. He added that he may call the FDA investigator to testify at a congressional hearing on the issue, although he has not determined if a hearing is needed yet.

Ketek, a Sanofi-Aventis drug used to treat respiratory infections in adults, recently came under scrutiny when research reports linked it to severe, potentially fatal, liver damage. Reports also alleged that a major Ketek study contained falsified data and that some doctors failed to keep proper records. One doctor was convicted of fraud.

The FDA approved Ketek in April 2004 after twice rejecting it for inadequate safety information. While the agency has acknowledged problems with some of the drug''s safety data, it said that the approval of the drug was based on sound evidence.

This is not the first time the FDA''s handling of drug safety issues has come under fire by the senator and his committee. In November 2004, one of the committee''s FDA safety reviewers accused the agency of being incapable of protecting the public from harmful drugs.