At the June 6 hearing, members of the House Oversight and Government Reform Committee grilled FDA Commissioner Andrew von Eschenbach on what they said was the agency’s failure to respond to warnings or the public about Avendia’s heart attack risks.
Committee Democrats called for increasing the FDA’s power to require post-approval testing of drugs.
Von Eschenbach would not pledge to support that step. And he said he opposed Tierney’s bill. “That would be more destructive than constructive to the ultimate outcome,” he said.
The commissioner announced at the hearing that the FDA would toughen safety warnings on Avandia and another drug. On June 4, the agency also announced the creation of a committee to study ways to better inform the public about drug safety.
Von Eschenbach also downplayed reported conflicts between the surveillance and drug evaluation offices, and attended the hearing with officials from both divisions at his side to show their “close interaction.”
The offices have recently exchanged fire over safety.
An official from the surveillance office argued at an April advisory committee hearing that drug approval officials insist on near-certain findings before alerting the public to risks.
And in a June 4 letter to von Eschenbach, Senator Grassley said “multiple sources” had reported that officials in the FDA’s surveillance office had been reprimanded for signing off on a Feb. 22 memorandum recommending the agency issue stronger warnings about potential heart attack and eyesight risks from Avandia.
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