By Clinical Research News Staff 

August 19, 2020 | The Food and Drug Administration released its nonbinding recommendations for civil money penalties relating to the data submitted to ClinicalTrials.gov earlier this week. They outlined how they plan to identify parties that have failed to submit required clinical trial registration or results information, what the investigation and notification process will be, and what civil money penalties may be assessed and when.

The National Institutes of Health and the Department of Health and Human Services published the Final Rule for Clinical Trials Registration and Results Information Submission in September 2016. The regulations were effective in January 2017 with a compliance date of April 2017. But since then, the enforcement procedures of that rule were not codified. This week’s recommendations outline the plan for enforcement.

Enforcement will be left to FDA’s Center for Drug Evaluation and Research (CDER), Center for Biological Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH). These Centers will work to identify when someone has failed to submit required clinical trial registration or results information, submitted false or misleading information to the data bank, or failed to submit or knowingly submitted a false certification to FDA through standard inspections or by following up on complaints.

As part of FDA’s Bioresearch Monitoring Program for Sponsors, Contract Research Organizations and Monitors, routine inspections are conducted of clinical trials to ensure that investigational products are manufactured and labeled correctly, that trials are not begun without approval, that adverse events are reported, final results are submitted, and more. These inspections could unearth noncompliance. Or the Centers may become aware of a violation based on complaints sent to the Agency.

The first step upon discovery of a violation will be to send a Preliminary Notice of Noncompliance (Pre-Notice) letter. This letter will be sent privately and starts a 30-day clock within which the sponsor or responsible party can address the violation. FDA intends to use a “risk-based approach to determine the situations in which Pre-Notice letters will be issued, the guidance states, with particular focus paid to failure to submit clinical trial registration or results, responsible parties with a pattern of noncompliance, and multiple issues of noncompliance within the same clinical trial. 

At the end of 30 days, FDA will conduct a further review and assessment of the information submitted to ClinicalTrials.gov. If the Centers determine that required data has not been submitted, the Agency will publicly post a Notice of Noncompliance, announcing that the responsible party has 30 days to remedy the noncompliance.

After this second 30-day period, FDA will consider what corrective actions have—or have not—been taken and decide whether or not to seek civil money penalties then. The maximum penalty allowed is $10,000 for all violations in a single proceeding, plus $10,000 per day for each day a violation is uncorrected within 30 days following notification. The amount of civil money penalty is dependent on the nature, circumstances, extent, and gravity of the violations, as well as the violator’s history of violations, degree of culpability, ability to pay, and ability to continue business.

If they decide to move forward, the Centers can file a complaint with FDA’s Division of Dockets Management, and the responsible party generally responds by either paying the penalty or contesting the allegations.