FDA Talking To Industry About Releasing “Complete Response” Letters
This article was originally published in The Pink Sheet Daily
Commissioner Hamburg says conversations are underway with industry to allow the agency to release its reasons for not approving a product, in part so others will not waste funds repeating known failures. FDA is also working to remove user fee revenue from sequestration.
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One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.
Gottlieb favors making the letters detailing application problems public, but industry still may oppose it; Senate schedules cloture vote for confirmation.
But Amgen is in good company when it comes to companies that choose not to disclose the contents of complete response letters, data from the Pink Sheet's FDA Performance Tracker show. Merck especially holds such information close.