Report: Toward greater transparency at FDA

The Food and Drug Administration plays a critical role in safeguarding public health through its regulation of human drugs, biologics, medical devices, tobacco products, food, and veterinary drugs. Yet, despite its scientific rigor and global reputation, the FDA has long faced criticism for being inadequately transparent about regulatory processes, data, and decisions – particularly those that relate to product approval and safety actions.

Public support for transparency is strong and bipartisan, and the new administration has adopted the phrase “radical transparency” to justify some of its policy actions. After reviewing the status of FDA transparency efforts since the external 2017 Blueprint for Transparency at the US Food and Drug Administration, we conducted 38 expert interviews and a literature review of 115 journal articles, identified through a formal literature search. We summarize our findings in this report to highlight areas of progress, identify persistent gaps in disclosure, and propose actionable steps to improve transparency.