Online FDA Resources Versus Data on File: Minimizing Data on File in Standard Medical Response Letters

Background: Reviewers’ summaries and other documents routinely posted on the FDA website have been cited in published studies and by tertiary drug information resources. Because they can contain information otherwise undisclosed to the public, they could potentially replace certain data on file references in standard medical response letters. Objective: The purpose of this study was to evaluate whether publicly available information from the FDA website (http://www.fda.gov) could reduce the need to use data on file as a reference in industry drug information service standard response letters. Methods: Eighty-six standard response letters for 4 drug products, containing 272 data on file references, were assessed to determine whether data on file could be replaced using online FDA medical reviews or advisory committee briefing documents. Results: Thirty-two percent (87/272) of data on file references were found to be replaceable with existing information on the FDA website. Conclusions: Online FDA resources may sometimes be used in lieu of data on file in standard medical response letters.