Lawsuit Asks FDA: “Where’s the Missing Data?”

A new lawsuit alleges that the U.S. Food and Drug Administration (FDA) is not holding clinical trial sponsors accountable for public reporting of clinical trials data. Peter Lurie, MD, MPH, who formerly worked on transparency issues at the FDA, and Charles Seife, MS, a New York University journalism professor, brought the suit against the FDA and the National Institutes of Health (NIH).

The legal requirement to submit results began in 2008 and stemmed from many cases in which companies allegedly hid negative clinical trials evidence about highly profitable drugs. However, the final rule that was adopted in 2018 retroactively forgives any violation from the previous 10 years. This lawsuit argues that this is inconsistent with the public-reporting requirement.

In an email to STAT News, Mr. Seife wrote: “A decade’s worth of data, of clinical trial results that the law says should be public, may never be revealed. And that’s not just wrong, it’s a violation of the letter, not just the spirit, of the law.”

Source: STAT News, December 11, 2018.