FDAnews Drug Daily Bulletin


May 19, 2006

Sen. Chuck Grassley (R-Iowa), the Senate Finance Committee chairman and a frequent FDA critic, is ramping up his investigation of the FDA's handling of sanofi-aventis' Ketek (telithromycin), arguing that the agency has been uncooperative in responding to earlier information requests.

Grassley previously argued in an April 27 letter that the FDA's review of Ketek was inadequate and relied on the company's allegedly fraudulent safety study. The senator has argued that the Ketek case was important because the agency's handling of this drug was indicative of flaws in its overall drug review system.

The senator has sought all data about the Ketek study, including administrative files from the agency's review of the study and a full briefing on the issue by agency staff. But the agency has been unresponsive to these requests, leading Grassley to send a recent letter to the FDA seeking more information, his spokeswoman Jill Kozeny said. "The FDA has an obligation to be forthcoming and open about its actions," Grassley said.

Now Grassley is also requesting an interview with the special agent in charge of the Ketek case and wants the FDA to turn over all documents related to that investigation. "Given the gravity of the Ketek allegations, I respectfully request that your staff contact my staff by no later than Thursday, May 18, 2006, to make arrangements for this interview and for the committee to obtain the requested documents from Special Agent [name withheld] by no later than May 24, 2006," he said.

The senator is also renewing his call on agency staff to feel free to serve as whistleblowers when they have concerns with FDA policy. In his April 27 letter, Grassley instructed the agency to inform their employees of their right to speak and to cooperate with Congress. FDA employees should also contact Congress if they believe the agency has retaliated against them for such cooperation, he said. (http://www.fdanews.com/did/5_97/)