FDA Chief: ‘Violations Have Gone Unaddressed for Far Too Long’
Published On: August 7th, 2009
Since the day she took office, FDA Commish Peggy Hamburg has been talking big about faster action on safety issues.
In a speech today, she described slow-moving deliberations — “back and forth, stall and delay, let’s see what the company does.”
Because the pathways the FDA must follow to take action are “too long and arduous,” she said, there have been cases where “serious violations have gone unaddressed for far too long.”
So the agency is looking to speed up the enforcement process by, among other things, setting post-inspection deadlines, improving follow-up after warning letters are issued and working more swiftly to act in the first place.
Companies will now have 15 days to respond to the FDA’s inspection findings, Hamburg said. And there may be instances where the FDA, in its efforts to act “swiftly and aggressively to protect the public”, considers immediate action before issuing the company a formal warning letter.
Photo: Associated Press
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FDA Chief: ‘Violations Have Gone Unaddressed for Far Too Long’
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