"The Thursday announcement follows the FDA's July move to publish more than 200 letters from 2000 to 2024 as part of its pledge for greater transparency. Along with pledging to publish all CRLs going forward, the FDA said in its latest announcement that 89 previously unpublished letters issued from 2024 to the present have been published. The agency said each letter details specific safety and efficacy deficiencies that prevented an FDA approval."
"The next time the FDA turns down a drug application, the letter outlining the decision and the regulator's reasoning will become public record. The agency said it will release future complete response letters (CRLs) "promptly after they are issued to sponsors." Companies have generally opposed publishing of CRLs. Besides not wanting a public airing of bad news about their drugs, they also do not want proprietary information disclosed."
"The FDA added that the investment community benefits from information about a drug in the proper context. "By embracing radical transparency - one of the guiding principles of this administration - we're giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust," FDA Commissioner Marty Makary said in the FDA announce"
The FDA will publish future complete response letters (CRLs) promptly after they are issued to sponsors and has released 89 previously unpublished 2024-era letters. Each CRL will detail specific safety and efficacy deficiencies that prevented approval and will be redacted to remove confidential commercial information, trade secrets, and personal private information while company names will be disclosed. The agency will also release all CRLs associated with approved drugs and publish batches of CRLs tied to withdrawn or abandoned applications. The agency expects these publications to help companies avoid repeated errors, inform patients and physicians, and provide context for investors.
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