Opinion: It’s time to levy penalties for failing to report clinical trial results

I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part of my firm’s FDA group, my job was to figure out what our clients needed to do to comply with FDAAA’s requirements for registering and reporting the results of their clinical trials on the government website at ClinicalTrials.gov.

The stakes were high enough to justify my hefty hourly rate — the prospect of an initial penalty up to $10,000 for not complying with the law’s requirements, followed by $10,000 a day if violations were not corrected within a 30-day period following notification of noncompliance. Institutions and investigators with National Institutes of Health funding also faced suspension or termination of grants and the possibility that their failure to comply with the rules would be