The Southern District of New York has ruled that government agencies, including the National Institutes of Health (NIH), the U.S. Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) have misinterpreted a law requiring them to collect and post data to Clinicaltrials.gov, a publicly accessible government database. If this ruling is upheld, it will make it more difficult for drug companies to stop unfavorable results from the public in a ruling that is a win for the democratization of clinical health data.
The Center for Science in the Public Interest reported that the ruling from the federal judge will significantly expand the public’s right to access the results of clinical trials studying drugs and medical devices. The ruling is the result of a lawsuit brought by plaintiffs’ Yale Media Freedom and Information Access (MFIA) and NYU Technology & Law & Policy (LTP) Clinics on behalf of Charles Seife and Dr. Peter Lurie, with the support of the Yale Collaboration for Research Integrity and Transparency (CRIT).
Judge Naomi Reice Buchwald of the Southern District of New York found that the FDA, NIH and the HHS have been far to loose in interpreting a 2007 law requiring the disclosure of clinical trials related data as published in the public website.
The Pendulum Swings
The defendants surely may appeal, but this represents an ongoing saga of demands for transparency over industry pragmatism. In 2015 STAT journalists found that universities vary widely in how they post clinical trial results. Reporting by Science found that the FDA has never imposed a fine on a clinical trials sponsor for not complying with federal regulations.