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FDA commissioner not a star witness

Executive Summary

The "accuracy and candor" of statements by FDA Commissioner Andrew von Eschenbach at recent House Energy and Commerce/Oversight and Investigations Subcommittee hearings concerning approval of Sanofi Aventis's Ketek are being scrutinized by the panel. In a letter to HHS Secretary Michael Leavitt, full committee chairman John Dingell, D-Mich., and subcommittee head Bart Stupak, D-Mich., request all briefing materials and communications related to von Eschenbach's remarks, as well as interviews with agency staff who helped prepare the testimony. The records were due by April 4, but the committee said it had not received an "adequate response"...

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Contentious Ketek correspondence

CDER officials reiterate that they did not rely on a fraudulent study to approve Sanofi-Aventis' antibiotic Ketek (telithromycin), in a letter in the April 19 New England Journal of Medicine. In response to a critical perspective article by former FDA reviewer David Ross, the FDAers say they "reviewed the study for safety findings that would have counted 'against the drug,' as is consistent with good review practice," and that data-integrity issues with study 3014 were not provided to an advisory committee so as not to compromise an on-going investigation. Not addressed by the response are Ross' charges that Ketek reviewers were subject to "overt internal pressure ... to alter their conclusions." Ketek's approval is being investigated by the House Energy and Commerce/Oversight and Investigations Subcommittee (1"The Pink Sheet" April 9, 2007, In Brief)...

Quick Listen: Scrip’s Five Must-Know Things

Join us for an audio catch-up on the latest key developments in the global biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.

Prop 65 Warnings Intended For Small Spaces But Used On Luggage? California Proposes Limits

California proposes limiting short-form Prop 65 warnings to products with 5 inches or less of labeling space, while prohibiting their use in online and catalog warnings. The number of products with the warnings, used even on vacuum cleaners, luggage and guitars, has made tracking them impossible.




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