FDAnews Drug Daily Bulletin

GRASSLEY THREATENS FDA WITH HEARINGS BASED ON KETEK INVESTIGATION

June 16, 2006
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Rebuffed in his attempt to force a face-to-face meeting with an FDA special investigator, Sen. Chuck Grassley has charged the agency with covering up problems with its review of the antibiotic Ketek and threatened to hold hearings on the way regulators determine the safety of drugs.

The Iowa Republican made a personal visit to the source of his displeasure, arriving at HHS headquarters in Washington a day after he sent the agency a letter demanding that the FDA provide him with information he has been seeking on the approval of sanofi-aventis' Ketek (telithromycin) and arrange a meeting with an agency special investigator.

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, 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.

Grassley contends that the FDA's handling of Ketek is indicative of flaws in the agency's overall drug review system. This situation "falls into the pattern" of FDA missteps in dealing with drug safety, Grassley said.

Grassley did meet with several high-ranking agency officials on June 14, including Vince Ventimiglia, HHS assistant secretary for legislation, and Casey Hemard, the agency's counselor on oversight to the assistant secretary for legislation. He also met with David Boyer, FDA assistant commissioner for legislation, and Horace Coleman, special agent in charge in the agency's Office of Criminal Investigations. But these officials refused to provide Grassley with access to the agent in charge of the Ketek investigation.

"I smell a cover-up," Grassley said of the agency's refusal to grant his request. Addressing the agency, Grassley said "it's probably not your intent to cover for companies, but every time you stand in the way of information getting out that ought to be public that's the impression you give the American people." Also, internal emails that he has obtained show the agency has a "cozy relationship" with industry, he added. (http://www.fdanews.com/did/5_117/)