Pharma Blog Watch
FDA
Hopes to Eliminate Industry Ties in Advisory Committees (In the Pipeline)
In his blog, Derek Lowe discusses last week's announcement by the FDA of a proposed
new rule on who can serve on an advisory committee. These committees sometimes
help make decisions on drug approvals. Under the draft rule, anyone with $50,000
or more in ties to drug companies cannot be on an FDA panel. "My guess
is that that's going to have a pretty big impact if it goes through, and that
we're going to see some very different committee rosters," he writes.
As far as conflicts of interest, "[t]he tough part is when a drug is on the edge of getting approved or not it has some good points, some bad ones and the decision could go either way," he continues. "That's when suspicions are raised that an extra $50,000 here and there is what tipped things over to approval."
But, he writes, "Many approvals can be honestly argued either way, because these medical questions are inherently one big gray area."
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