FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.”
The basis for the document is to provide FDA’s current thinking on answers to the following questions:
- How will violations (either failure to submit data or submitting false data) to required reporting to ClinicalTrials.gov be identified?
- When might civil money penalties be sought?
- What procedures apply when a Center seeks civil money penalties?
- What civil money penalty amounts may be assessed for various violations?
The Draft Guidance describes that violations will be identified mainly through the Bioresearch Monitoring Program (BIMO) as described in FDA’s Bioresearch Monitoring Compliance Program for Sponsors, Contract Research Organizations and Monitors. (Note: IMARC audits are conducted using this Program Manual as guidance.)
Violations may also be identified from complaints.
If potential violations are identified, a process for issuing a Preliminary Notice of Noncompliance (Pre-Notice) Letter and subsequent follow-up requirements are outlined in the Draft Guidance. The FDA will follow 21 CFR 17 when seeking civil money penalties. The statutory maximum penalties under the FD&C Act for these violations are not more than $10,000 for all violations adjudicated in a single proceeding, and, if a violation is not corrected within 30 days following notification, not more than $10,000 for each day that the violation continues after such period until the violation is corrected.
The Draft Guidance is available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Comments are being accepted until November 20, 2018.
Do you believe the actions described are enough to enforce accurate and timely reporting to ClinicalTrials.gov? Read the Draft Guidance and consider submitting comments!