White House Mulls Proposal To Pause FDA's Quality Metrics Initiative
Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.
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Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.
The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."
Indian firm's invalidated out-of-specification rate was too high, FDA suggests in heavily redacted Form 483 report. This rate, which also came up in two recent warning letters, happens to be one of the three rates the USagency wants to use as quality metrics for deciding how soon investigators should revisit sites.