FDA Will Fine Sponsors for Unreported Trial Data

Last month, the FDA published a draft guidance document relating to potential fines that may be incurred if submitters of data and trial information on clinicaltrials.gov either do not report clinical trial results, or misreport findings.

The document, “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” explains that under section 303(f)(3) of the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA is authorized to assess civil money penalties against responsible parties and/or submitters of applications for drug products, biologics, and devices.

The guidance also answered some general questions, such as how the FDA intends to identify whether an organization or someone has failed to submit required clinical trial registration and/or results to the data bank or submitted false information. The FDA plans to identify such violations through evidence collected during inspections, as well as through complaints received by the agency.

If the agency has deemed that a party has failed to comply with regulation, it “intends to send the responsible party a Preliminary Notice of Noncompliance (Pre-Notice) Letter, which describes the potential violation and requests that the responsible party review the record in the ClinicalTrials.gov data bank and make any necessary corrections within 30 days,” read the document. If the violation has not been addressed in the 30 days, the agency will then send a Notice of Noncompliance, which allows the party an additional 30 days to remedy the situation.

Should a civil money penalty be assessed, the statutory maximum penalties under the FD&C Act are no more than $10,000 for all violations adjudicated in a single proceeding. In addition, if a violation is not corrected within the 30 days following notification of a violation, an organization can be fined up to, but not more than, $10,000 per day the violation continues.

This guidance document comes after AllTrials, an international initiative, launched a tracking tool in February 2018 that publicly discloses which research entities have not reported data from clinical trials.

Included in the announcement of the initiative was an open letter to FDA Commissioner Scott Gottlieb, MD, that noted that the FDA has the power to sanction such violators and institute fines against clinical trial sponsors that fail to report trial results, and urged the Commissioner to do just that.