By Phebe Hong
Data is knowledge, and knowledge is power. Thanks to a recent court ruling, more medical data may soon be available to the public. A Southern District New York federal judge ruled this week that the FDA and NIH had been misinterpreting a law requiring clinical trial sponsors to release data. The ruling clarifies that reporting requirements – previously applied only to trials completed after 2017 – actually applies to trials completed since 2007. As a result, many pharmaceutical companies, biotechs, universities, and other institutions will have to provide previously unpublished data (or risk non-compliance).
The ruling of Seife v. HHS has been broadly summarized by STAT, Endpoint News, and Science Magazine. Here, we take a closer detailed look at the court’s legal opinion and reasoning: