FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018.  The FR Notice announcing the availability of the guidance (here) indicates the final guidance was prepared taking into consideration comments received on the draft guidance.  Revisions to the guidance include:

  • FDA agreeing not to include specific observations “regarding potential violations relating to the ClinicalTrials.gov data bank” as 483 findings but they may be included in the EIR to the firm.
  • Clarifying that when determining civil penalties, the Agency will take into consideration corrective actions taken by the respondent.
  • FDA indicating that it will post notices of noncompliance on its web site, as well as forwarding such notices to NIH.
  • NIH being required to post the notice of noncompliance on clinicaltrials.gov.
  • There are also some examples of trials that may present a higher potential for risk to human subjects (in which case the Agency is more likely to take enforcement action for noncompliance.

The final guidance is broken down into the following sections:

  • Definitions
  • How do the Centers intend to identify whether someone has: failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank; submitted false or misleading information to the data bank; or failed to submit or knowingly submitted a false certification to FDA?
  • Under what circumstances may a Center decide to seek civil money penalties?
  • What procedures apply when a Center seeks civil money penalties?
  • What civil money penalty amounts may be assessed?

It is imperative for firms to understand both the reporting requirements, as well as the potential exposure, as fines are not trivial.  As the FDA guidance reports:

“The statutory maximum penalties under section 303(f)(3)(A) of the FD&C Act34 for committing these prohibited acts 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 of such violation, section 303(f)(3)(B) of the FD&C Act35 provides for an additional civil money penalty of not more than $10,000 for each day that the violation continues after such period until the violation is corrected.”

There is a substantive discussion of each of the topics that should assist firms in identifying when they may be in noncompliance, what causes noncompliance, and how firms can avoid noncompliance.