FDA Final Guidance on Civil Money Penalties Relating to Trial Disclosure

Thomas Wicks

August 17, 2020

The FDA has issued the final guidance related to financial penalties for non-compliance with U.S. disclosure regulations. Read the full guidance by visiting https://www.fda.gov/media/113361/download.

Following is a summary of the steps the FDA will take in issuing financial penalties for noncompliance with 402(j) of the Public Health Service Act (PHS Act) and 42 CFR part 11:

  1. The Center* identifies a violation through the FDA’s Bioresearch Monitoring Program (BIMO) or based on the evaluation of complaints received by the Agency.
  2. The Center will send the responsible party a Preliminary Notice of Noncompliance (Pre-Notice) Letter, which describes the potential violation and requests that the responsible party take any necessary actions to address the potential violation within 30 calendar days after receiving the letter. Failure to comply with the requirements relating to applicable clinical trials may result in further regulatory action by the Center, including the issuance of a Notice of Noncompliance, civil money penalties, injunction and/or criminal.
  3. 30 days after issuing a Pre-Notice letter, the Center will follow up on the violation, and if it is determined that a submitter failed to submit the required certification to the FDA or knowingly submitted a false certification, the Agency intends to issue a Notice of Noncompliance to the submitter, giving the sponsor another 30 days to remediate. The Notification of Noncompliance will be made publicly available on the agency’s website and transmit the Notice of Noncompliance to NIH so it can include the notice regarding noncompliance on ClinicalTrials.gov.
  4. Failure to remediate the issues identified in the Notification of Noncompliance within 30 days means that the Center intends to seek civil money penalties, taking into account the type of noncompliance and the circumstances associated with the lack of remediation.

* Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH)

About the author

Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Thomas has been focused on trial transparency since 2007.