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When the US Food and Drug Administration (FDA) declines to approve an application to market a drug, it informs the sponsor (the drug company) sin a complete response letter. These letters systematically document deficiencies that FDA reviewers have identified and typically explain corrective actions sponsors can take.
With limited exceptions, the public does not receive a full account of the FDA’s reasons for disapproval because complete response letters are part of unapproved applications that FDA regulations generally treat as confidential. Some have called on the FDA to publicly disclose the complete response letters, arguing this would ensure a more accurate portrayal of their reasoning and would allow sponsors, researchers, and clinicians to learn from previous scientific and regulatory failures.
Some members of the pharmaceutical industry, however, have opposed the disclosure of any information that could be considered proprietary and confidential and have suggested that the release of complete response letters would provide an advantage to competitors.
Sponsors might issue press releases for complete response letters they receive, presumably, in part, because US securities laws require companies to disclose information that investors would be substantially likely to consider important in making investment decisions. By aggregating data for all recent complete response letters so that sponsors and specific drug products are not identifiable, we characterized the reasons cited by the FDA for not approving drug marketing applications and the degree to which sponsors’ public statements reflected those complete response letters. Given the distinct purpose and usual brevity of press releases, we would not expect that they would necessarily cover all components of complete response letters issued by the FDA.