Gottlieb Q&A: Confirmation Is Nearing, Will Complete Response Letters Finally Get Released?
Gottlieb favors making the letters detailing application problems public, but industry still may oppose it; Senate schedules cloture vote for confirmation.
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US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.
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.'
One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.