GRASSLEY REHEATS KETEK INVESTIGATION

Sen. Chuck Grassley (R-Iowa) has taken his investigation into the FDA's handling of clinical trial fraud to a new level, asking the nation's top law enforcement official to explain why the FDA is refusing to provide access to one of its investigators.

At a July 18 Senate Judiciary Committee hearing, Grassley, a member of the committee, demanded that U.S. Attorney General Alberto Gonzales explain why the federal government will not provide him access to an investigator who is looking into fraud that compromised a study on the safety of sanofi-aventis' antibiotic Ketek.

Grassley was livid that HHS, on behalf of the FDA, had consulted with the Department of Justice regarding the executive branch assertions of confidentiality in an effort to prevent his access to the investigator, he said. This discussion "is part of a concerted effort to obstruct legitimate congressional oversight into government misconduct, and what is bothering me is a fundamental disregard for constitutional mandates, long-established historical precedents and bedrock legal rulings," Grassley said. "Frankly, I am angered by these obstructive policies and principles."

Grassley wants answers from Gonzales by July 21 as to why the government will not provide him access. "I want to know the legal justification, not policies and principles, for denying access to deliberative prosecutorial documents and for obstructing interviews with line agents in the performance of my oversight responsibilities to examine allegations of government misconduct," he said. Grassley's office did not respond to a request for Gonzales' initial answer to this question.

Grassley, the chairman of the Senate Finance Committee, has been asking the agency since April for information about fraud that allegedly compromised a study on the safety of Ketek (telithromycin), but has yet to receive answers to his questions. The final straw came when the FDA denied Grassley's request to meet with the agency investigator in charge of the Ketek review.

While the agency later changed the labeling requirements for Ketek to highlight the risks of liver failure, this was not enough for Grassley. Soon after the FDA changed the label, the senator blasted the agency for turning a "blind eye to serious safety concerns."

The FDA did not respond to a request for comment. (http://www.fdanews.com/did/5_140/)