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Regulatory Focus™ > News Articles > 9 > Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Posted 20 September 2018 | By Zachary Brennan 

Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday in draft guidance.

According to FDA, the 8-page draft is meant to address four issues:
  1. How FDA’s centers identify whether responsible parties have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov or submitted false or misleading information to the data bank, and whether submitters have failed to submit the certification required by the Public Health Service Act (PHS Act) to FDA or knowingly submitted a false certification to FDA.
  2. Under what circumstances an FDA center may decide to seek civil monetary penalties against a responsible party or submitter.
  3. What procedures apply when an FDA center seeks civil monetary penalties.
  4. What civil money penalty amounts may be assessed for: (1) failing to submit required clinical trial registration and/or results information to ClinicalTrials.gov, (2) knowingly submitting false or misleading clinical trial information, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA.
For the first point, FDA notes that violations will be found “through evidence collected during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO)” or as a result of complaints received by the agency.

When a responsible party is found to be failing to comply with the PHS Act, FDA will send a Preliminary Notice of Noncompliance (Pre-Notice) Letter, describing the potential violation and requesting that the responsible party review the record in the ClinicalTrials.gov data bank and make any necessary corrections within 30 days.

FDA said it intends to use a risk-based approach to determine the situations in which Pre-Notice Letters will be issued consistent with FDA’s public health mission and will focus on three areas: Those who have failed to submit required clinical trial registration and/or results for “higher risk applicable clinical trials or applicable clinical trials of public health importance,” for those with a “pattern of previous noncompliance” and for when noncompliance exists in conjunction with potential noncompliance with other statutory and or regulatory requirements pertaining to the conduct of a clinical trial.

Following the issuance of a Pre-Notice letter, FDA will conduct a further review and assessment of the clinical trial information submitted to ClinicalTrials.gov and other information available to FDA, and if a responsible party has failed to comply, there may be further FDA regulatory action, including the issuance of a Notice of Noncompliance, civil monetary penalties, injunction and/or criminal prosecution.

“The statutory maximum penalties under the FD&C Act for committing these prohibited acts are not more than $10,000 for all violations adjudicated in a single proceeding,” the draft says. And if a violation is not corrected within 30 days following notification of such violation, “not more than $10,000 for each day that the violation continues after such period until the violation is corrected.”

But FDA will also evaluate certain conditions for each unique situation.

“In determining the amount of civil money penalty under the relevant statutory limits, the following factors are considered: the nature, circumstances, extent, and gravity of the violation(s) and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability and such other matters as justice may require,” the draft adds.

The draft guidance comes as a recent BMJ paper found that 49% of clinical trials on the EU register have not reported results, while a US study from 2015 found about 20% of industry trials did not report results when required to do so, while about 50% of NIH-sponsored research went unreported. Science’s In the Pipeline has more color on that data.

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Industry

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