Ketek investigation forces standoff between FDA and Grassley
FDA directorial candidate refuses to give Congress committee Ketek information; confirmation blocked - 12/1/06
On November 30, 2006, the U.S. Department of Health and Human Services reported that Dr. Andrew von Eschenbach refused to disclose information to a Congressional committee investigating the FDA's handling of the controversial antibiotic Ketek. Ketek, manufactured by the French company Sanofi-Aventis SA and primarily prescribed for respiratory infections, is currently being investigated by Congress due to reports of over 100 adverse renal events in the United States in patients on the antibiotic. Ketek has been responsible for four deaths among 12 documented cases of acute liver failure.
Senator Charles Grassley (R-IA) has been critical of the FDA's handling of Ketek since three doctors involved in a clinical trial of the drug were investigated for malfeasance. One Ketek trial doctor was jailed for fraud. As chair as the Senate Finance Committee, Sen. Grassley has repeatedly pushed for stronger Senate oversight of the FDA. While no Ketek recall has been issued, the drug could become the focus of several personal injury lawsuits related to its liver risks.
Von Eschenbach, who serves as acting chief of the FDA but has not been confirmed by the U.S. Senate, stated in a written response to questions by the Senate Finance Committee that full disclosure of trial and safety data information would have a "chilling effect" on the FDA's ability to independently and effectively evaluate the safety of drugs brought to the agency for marketing approval. The agency stated they have granted the committee access to as much sensitive data as they could while still remaining "stewards" of "extraordinarily sensitive information."
In response, Sen. Grassley has promised to block von Eschenbach's confirmation as FDA director due to his "resistance . . . to congressional oversight," describing the agency's compliance with their requests for information as "selectively providing documents" for the committee's review.
"The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government," Grassley said.
Source: Associated Press, "FDA, lawmaker clash over antibiotic," November 30, 2006.
