FDAnews Drug Daily Bulletin

FDA COOPERATES WITH GRASSLEY'S KETEK REVIEW

May 23, 2006
A A

The FDA has relented to repeated requests by Sen. Chuck Grassley (R-Iowa) for information related to its controversial approval of the antibiotic Ketek, just days after missing a deadline set by the Senate Finance Committee chairman late last week.

Grassley and FDA officials reached an agreement under which the agency will provide the all the information the senator had been seeking since late April on the review of the drug, according to Grassley spokeswoman Jill Kozeny.

Grassley, a frequent FDA critic, is investigating the agency's handling of sanofi-aventis' Ketek (telithromycin). The senator argues that the FDA continues to base its estimation of the drug's safety on a study that the agency itself found was "riddled with fraudulent information." Grassley contends that the FDA's handling of Ketek is indicative of flaws in the agency's overall drug review system.

Grassley initially asked the FDA in an April 27 letter to provide him with all the data related to the Ketek study, including administrative files from the agency's review of the study. In that letter, he also asked that his staff be briefed within three weeks by the director and deputy director of the Office of New Drugs, the director and deputy director of the Office of Drug Evaluation IV and the director of the Division of Anti-Infective Drug Products.

The FDA did not provide Grassley with any of the information he requested, and the briefing never occurred. It was unclear May 19 whether the agreement between Grassley and the FDA would include such a briefing. Contacted for comment on the issue May 19, the FDA would say only that discussions with the senator were ongoing.

Grassley followed his April 27 letter with another letter to the agency on May 16. In that letter, he requested an interview with the special agent whose investigation of the Ketek study resulted in the successful fraud prosecution of a doctor involved in the study.

The senator also reiterated his request that all FDA staff directly or indirectly involved with Ketek be given a copy of his April 27 letter and informed of their right to speak to and cooperate with Congress. He also reminded the agency of his request that all FDA employees be instructed that "no documents, records, data or information related, directly or indirectly, to Ketek shall be destroyed, modified, removed or otherwise made inaccessible to the committee." (http://www.fdanews.com/did/5_100/)