8/25/2020
Photo by Josh Appel on Unsplash
The Food and Drug Administration (FDA) released a final guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” It clarifies how the FDA determines that “responsible parties” have submitted registration information when required, that the information submitted is factual, and when noncompliance results in civil money penalties.
Background
Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.
Summary of Guidance
Question: Which factors are considered for determining if the responsible party 1) failed to register or submit results to ClinicalTrails.gov, 2) submitted false or misleading information to ClinicalTrails.gov, or 3) failed to submit or submitted false certification to the FDA?
Summary answer: The FDA will collect information during its inspections related to the Bioresearch Monitoring Program (BIMO), through complaints submitted to the FDA, or through other publicly available means such as the information submitted to ClinicalTrials.gov.
Question: When can the appropriate FDA Center can seek civil financial penalties?
Summary answer:
The appropriate Center will send the responsible party a Preliminary Notice of Noncompliance (Pre-Notice) Letter, which requires necessary actions to comply within 30 days.
The decision on whom to send the Pre-Notice Letter is based on collected evidence and a risk-based approach on where to focus efforts.
Thirty days after the Pre-Notice Letter, the Center reviews the information submitted. If the responsible party failed to submit or submitted false or misleading information to ClinicalTrials.gov or certification to the FDA, a Notice of Noncompliance is issued.
This notice is posted on FDA’s website and the recipient has 30 days to correct the noncompliance.
If the corrective action is inadequate, then civil money penalties come into place.
Question: What is the process for the appropriate FDA Center to seek civil financial penalties?
Summary answer: The procedure is described in 21 CFR part 17. Usually, the responsible party will either pay the penalty or contest it by filing an answer to the complaint.
Question: What civil money penalty amounts may be assessed?
Summary answer: Civil money penalties fall under section 301(jj) of the FD&C Act. The most up-to-date penalty amounts are listed in 45 CFR 102.3.
- The Clinical Pathways Team
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