⚖ Understanding Civil Money Penalties

In this blog, you’ll explore three key aspects:

Civil Money Penalties Unveiled
Civil Penalties in Clinical Activities
Penalty Amounts in Pharmacovigilance

Stay tuned for a comprehensive overview of civil money penalties and their implications on both clinical and pharmacovigilance activities.

Table of Contents:

Introduction
FDA Regulations on Civil Penalties
Circumstances may trigger civil money penalties
Preventing Penalties: Effective Measures
Unknown realities
References
FAQ

Introduction

The term “civil money penalty” and “civil monetary penalty” are the amount of monetary penalty to which or whom failed to submit or knowingly submitted a false information of critical safety data from clinical trial study or safety study. This law mandated by regulatory authorities like FDA.

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This blog is exclusively based on civil penalties under the FDA.

FDA Regulations on Civil Penalties

The terms “civil money penalty” and “civil monetary penalty” used interchangeably and mean a monetary penalty assessed under section 303(f)(3) of the FD&C Act9 for prohibited acts (found in section 301(jj) of the FD&C Act10) relating to the submission of clinical trial registration and results information to the ClinicalTrials.gov data bank and certain certifications to FDA.

“In the landscape of responsibility, a civil monetary fine serves as the toll booth that bridges accountability and consequence, paving the way for a path where adherence and integrity converge.”

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The requirements have been in force since 2007 and were part of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 402(j) of the Public Health Services Act, and the Final Rule for Clinical Trials Registration and Results Information Submission.

With the recent Federal Court decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020), clinical trial records that were previously compliant can now marked as non-compliant.

Circumstances may trigger civil money penalties

Civil money penalties may assessed under section 301(jj) of the FD&C Act33:

Failing to report adverse event
Not complies with regulatory activity
Not complies with post-marketing surveillance/pharmacovigilance requirements
Not following proper safety monitoring procedure
Submitting false or misleading information
Failed to register an applicable clinical trial

Preventing Penalties: Effective Measures

Within the FDA’s purview lies the power to impose civil money penalties for infractions. Failure to enact sufficient corrective measures within 30 calendar days of a noncompliance notice could expose the responsible party to financial penalties.

Furthermore, these breaches may trigger additional regulatory responses, including injunctions or even criminal prosecution.

When considering civil money penalties, FDA will consider any corrective action that taken by a responsible party after receiving a pre-notice and a notice of noncompliance.

Unknown realities

The fine amount is not specified; however, there are nonbinding recommendations suggesting that the penalty for all violations does not exceed $10,000 for the initial 30 days. Beyond this period, an additional charge of $10,000 accrues for each subsequent day until the violation corrected.
There isn’t a dedicated law specifically mandated for pharmacovigilance.
The penalty will enforce if any unspecified action taken within a 30-day time-frame.
The Attorney General may recover any civil penalty.

References:

FAQ:

What are civil money penalties?

Civil money penalties, also referred to as civil monetary fines, are imposed upon individuals or entities that fail to submit or intentionally provide false information regarding critical safety data in clinical trial studies or safety studies.

At what point in time were these civil money penalties introduced?

The requirements have been in force since 2007 and were part of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Is it possible to evade civil money penalties, and if so, what measures can be taken to achieve this?

Yes can be avoided, when the corrective measures within 30 calendar days of a noncompliance notice.

What is the spectrum of minimum to maximum amounts for penalties incurred due to failure or misrepresentation of data?

While the situation varies case by case, according to clinicaltrial.gov, initial violations do not exceed $10,000 for the first 30 days. After this period, an additional charge of $10,000 per day applies until the violation is corrected.

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