Civil money penalties on CT.gov: the guidance

We gladly receive and publish the article by Robert Paarlberg on the issuing of the FDA final guidance on the Civil Money Penalties relating to ClinicalTrials.gov.

On August 14^th FDA issued a final guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.  The guidance finalizes the draft guidance dated September 21, 2018.  The Federal Register notice announcing the availability of the final guidance was published on August 17^th.

The final guidance addresses the following topics.

1. How FDA’s Office of Good Clinical Practice (OGCP), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiologic Health (CDRH), and Office of Regulatory Affairs (ORA) may identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the govdata bank or submitted false or misleading information to the data bank, and whether submitters have failed to submit the certification required by section 402(j)(5)(B) of the PHS Act to FDA or knowingly submitted a false certification to FDA.
2. Circumstances under which an FDA Center may decide to seek civil money penalties against a responsible party or submitter.
3. Procedures that apply when an FDA Center seeks civil money penalties.
4. Civil money penalty amounts that may be assessed for: (1) failing to submit required clinical trial registration and/or results information to the govdata bank, (2) knowingly submitting false or misleading clinical trial information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA.”

The final guidance also:

• Clarifies that FDA does not intend to include on its Lists of Inspectional Observations, Forms FDA 483, any inspectional observations regarding potential violations relating to the govdata bank; however, information that is collected by an investigator regarding potential violations of such requirements will be included in an Establishment Inspection Report (EIR) and provided to the relevant FDA Center for further evaluation.
• Clarifies in determining whether to seek civil money penalties, FDA intends to take into consideration any corrective action taken by a responsible party or submitter after receiving a Notice of Noncompliance.
• Further explains that FDA intends to post Notices of Noncompliance on its website and to transmit the Notices of Noncompliance to the National Institutes of Health (NIH), so NIH can include the notice regarding noncompliance required under section 402(j)(5)(E) of the PHS Act in the govdata bank.
• Provides limited examples of Applicable Clinical Trials (ACTs) of products that potentially may pose a higher risk to human subjects or ACTs of products intended to address significant public health need.
• Makes editorial changes to improve clarity.

It is also interesting to note that the FDA issued the final guidance on Civil Monetary Penalties so quickly following the July 30^thletter the National Institutes of Health (NIH) sent to trial sponsors to upload missing data from clinical trials to comply with the February 24, 2020 Federal Court Decision in Seife et al. v. HHS et al., 18-cv-11462.  The February 24^th Federal Court ruling requires some clinical studies conducted between 2007 and 2017 previously determined to be probable Applicable Clinical Trials (pACTs) under the FDA Amendments Act (FDAAA) are now required to post clinical study results.  The July 30^th NIH letter states the results of pACTs should be sent “as soon as possible,” but it doesn’t specify a timeline.