FDA Has Neglected Clinical Trial Transparency — Plus $45 Billion in Fines
— It's time for more aggressive enforcement of the law
by Megan Curtin, Navya Dasari, Justin Mendoza, MPH
The FDA recently requested $7.2 billion for its 2024 budget -- an increase of $372 million from 2023. However, missing from that request is urgently-needed support for FDA enforcement of clinical trial transparency, despite thousands (and counting) of trials not reporting results as required by law.
When patients enroll in clinical trials, they reasonably assume that the research results will be shared with the public, physicians, and fellow patients. In 2019, however, our organization, Universities Allied for Essential Medicines (UAEM), found that the top U.S. universities were failing to reportopens in a new tab or window their results to a public database on time -- and flagrantly violating federal law in the process. Unfortunately, this problem is not a new one, and neither is the FDA's lack of urgency in solving it.
