Tuesday, August 07, 2007

From Forbes: Unsafe at the FDA

From Forbes.com, this scathing assessment over the Avandia hearings last week:

"The biggest damage from the proceedings [as to Avandia] may be to the FDA itself." During the process of the meetings, "the agency displayed its weaknesses on drug safety and the wounds that have been caused by years of controversy, giving the agency's critics more ammunition."

First there was the conflict: David Graham, a drug safety reviewer who played a key role in the mounting criticisms of Vioxx, told the advisory panel that Avandia should be pulled off the market. His boss, Gerald Dal Pan, head of the FDA's Office of Surveillance and Epidemiology, backed him up. But Robert Meyer, a top official in the office that approves drugs, took a more tempered stance, admitting there were fundamental disagreements at the FDA about what to do with Avandia."

Good work by David Graham. Once again, shame on the FDA.

For more, go here.