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www.fdanews.com/articles/90505-aggressive-culture-of-approval-harms-fda-drug-review-process-witnesses-say

AGGRESSIVE 'CULTURE OF APPROVAL' HARMS FDA DRUG REVIEW PROCESS, WITNESSES SAY

February 14, 2007

A forceful "culture of approval" and attempts to muffle scientific dissent among agency reviewers have created significant problems in the FDA's drug review process, witnesses at a House subcommittee hearing testified.

Supervisors at the agency discourage disagreement, ignore safety data and warnings and block access to information so they can rush drugs to market, former FDA employee David Ross said at a House Subcommittee on Government Oversight and Investigations hearing Feb. 13.

Significant adverse events seen with approved drugs such as Vioxx, selective serotonin reuptake inhibitors and Ketek reveal an agency that puts public safety in the back seat, Sen. Chuck Grassley (R-Iowa) said. Grassley has accused the agency of misleading an advisory committee reviewing sanofi-aventis' Ketek and denying him access to risk information about the drug.

The FDA recently removed two approved uses from Ketek's labeling, leaving it approved to treat only community-acquired pneumonia. Grassley said he was "heartened" to hear the agency was listening to the recommendations of its advisory committees, but said the agency had no good excuse for its roadblocks stopping Congress from accessing information on Ketek.

The agency's focus on getting new products to market comes at the expense of a thorough and accurate drug review process, Ross testified. Senior managers try to stifle dissent in drug reviewers so products can pass through the process quickly, he added.

Ross noted a June 2006 meeting when agency Commissioner Andrew von Eschenbach compared the FDA to a football team and told reviewers that if they discussed problems with Ketek with anyone outside the FDA, they would be "traded from the team." Ross, who was the primary safety reviewer for Ketek, left the FDA after the Ketek review.

(http://www.fdanews.com/did/6_32/)