Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA Discretion

Judge Naomi Buchwald of the District Court for the Southern District of New York recently found that the Department of Health & Human Services (“HHS”) misinterpreted a federal law requiring it to collect and post data for certain clinical trials, resulting in a 10-year gap in data that must be made publicly available. This decision will affect many clinical trials conducted between the time of the passage of the FDA Amendments Act (“FDAAA”) in September 2007 and the effective date of HHS’s Final Rule in January 2017 – meaning drug companies, medical device manufacturers and academic institutions will be required to post clinical trial data from clinical trials conducted during this time period.