July 24,2007

Grassley, Baucus reveal effort by the FDA to suppress scientific dissent and downplay safety concerns

WASHINGTON — Sens. Chuck Grassley and Max Baucus are sounding the alarm about a second senior FDA official who was sidelined after voicing safety concerns about the diabetes drug Avandia, and they are questioning the make-up of an FDA committee assigned to review emerging risks about the drug.

The senators have asked the FDA Commissioner to account for what they’ve learned through investigative staff interviews of FDA scientists in advance of next week’s FDA advisory committee meeting about Avandia.
Baucus and Grassley said they were troubled by reports that the composition of the advisory committee that will conduct this review favors the perspective of the FDA office that approved the drug rather than the FDA office that is responsible for post-market drug surveillance.

“The FDA undermines public safety every time it works to muzzle one of its own scientists. It’s time to stop this dangerous and repetitive practice where the FDA tries to shoot the messenger when it doesn’t want to hear the message,” Grassley said. “It also destroys the checks and balances that ought to be part of the FDA’s work to look out for the public interest when FDA leaders give more say and more sway to the office in charge of drug approval than they do to the office in charge of post-market review with questions of drug safety.”

“Hardworking and knowledgeable employees at the FDA strive to keep Americans and their health care providers informed about drug safety, but under Commissioner von Eschenbach’s leadership it seems that drug manufacturers’ interests may be allowed to trump science,” said Baucus. “Based on our ongoing investigation, it appears that FDA staff who voiced safety concerns about Avandia were removed from the very jobs that are supposed to protect the American public. The news that FDA will hold an Advisory Committee meeting on July 30th regarding Avandia is a promising development. The FDA must make decisions that are based on science and aim to protect the health of the American public.”

The text of the Grassley-Baucus letter to Commissioner Andrew C. von Eschenbach follows here.