Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen
One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.
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Legislative proposal in FY 2020 budget request wouldn't necessarily reduce number of complete response letters, but ability to require reports and postmarket changes on quality issues might eventually create more flexibility during initial product reviews.
Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'
US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.