Dec 04 2018

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

By Denis Okumu, Ph.D., Postdoctoral Fellow at Cato Research Ltd

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA) amended section 402(j) of the Public Health Service (PHS) Act[1] to require that responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA for certain “applicable clinical trials.”  Form FDA 3674[2] offers guidance on certifications to accompany such applications/submissions.  42 CFR Part 11 stipulates that a clinical trial must be registered within 21 calendar days of enrollment of the first subject, and results must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.  Section 303(f)(3)[3] of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess civil money penalties against submitters who violate applicable prohibitions found in section 301(j) of the FD&C Act relating to requirements cited above under section 402(j).  Accordingly, FDA’s Draft Guidance  (September 2018) describes the current thinking of FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, “Center” or collectively, “the Centers”), regarding civil money penalties against submitters who fail to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, submit false or misleading information to the data bank, fail to submit to FDA the certification required, or knowingly submit a false certification.  The draft document comes against a backdrop of recent findings that show increasing numbers of clinical trials on the European Register, as well as US industry trials and NIH-sponsored research did not report results as required.[4],[5]

The Centers intend to identify violations relating to posting on ClinicalTrials.gov data bank through evidence collected during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO) as well as from complaints the agency may receive.  FDA’s Bioresearch Monitoring Compliance Program Guidance Manual 7348.810 for Sponsors, Contract Research Organizations and Monitors[6] outlines how the Centers will gather information to assess compliance with the above requirements:

  • determine whether the study is an applicable clinical trial
  • determine the submitter, the address, and contact information for the submitter
  • determine whether the study was registered on ClinicalTrials.gov and identify the National Clinical Trial Number
  • determine whether the study was registered not later than 21 days of enrollment of the first subject
  • determine the study’s completion date
  • determine whether the submitter has completed and submitted Form FDA 3674
  • determine whether, on the informed consent form, it states that a description of the clinical trial will be available on ClinicalTrials.gov

When a Center believes an infraction has occurred, it will send the submitter a Preliminary Notice of Noncompliance (Pre-Notice) Letter that describes the potential violation and asks the submitter to review the online data bank and make any necessary revisions within 30 days of receiving the letter.  The Center makes it clear in this letter that a further review and assessment of the online data bank will be done after 30 days, and that failure to comply with the requirements may result in the issuance of a Notice of Noncompliance under section 402(j)(5)(C)(ii) of the PHS Act.[7]  The Notice of Noncompliance gives the submitter an additional 30 days to remedy noncompliance.  If noncompliance is not remedied after 30 days, the Center will seek civil money penalties, injunction, and/or criminal prosecution.

Civil money penalty actions start when the responsible Center files a Complaint with FDA’s Division of Dockets Management and serves the Complaint on the submitter.  The Complaint will detail allegations of liability, violations, reasons why the submitter is responsible for the violations, and the amount of money penalties and assessments sought.  The Complaint also includes instructions to the submitter on how to file an Answer to request a hearing within 30 days of service, and warns that failure to do this will lead to imposition of the sought amount of penalties and assessments as provided in law.  Upon being served, the submitter may pay the penalty sought in the Complaint, or file an Answer to contest some or all of the Center’s allegations.  While waiting for a hearing, a submitter and its representatives may engage in settlement discussions with the Center regarding the civil money penalty.  If the case is decided by a presiding officer, any dissatisfied party can appeal to the Department of Health and Human Services (HHS) Departmental Appeals Board (DAB), pursuant to 21 CFR 17.47.  As outlined in section 303(f)(6) of the FD&C Act,[8] the respondent may appeal an adverse DAB decision to the U.S. Court of Appeals for the District of Columbia or any other circuit in which the respondent resides or transacts business.

If a violation is not corrected within 30 days following notification of such violation, section 303(f)(3)(A) of the FD&C Act[9] stipulates statutory maximum penalties of not more than $10,000 for all violations adjudicated in a single proceeding, and not more than $10,000 for each day that the violation continues uncorrected as described in section 303(f)(3)(B) of the FD&C Act.[10]  Per section 303(f)(5)(B) of the FD&C Act,[11] the amount of civil money penalty under the relevant statutory limits is dependent on the nature, circumstances, extent and gravity of the violation(s), and the violator’s ability to pay, effect on ability to stay in business, any history of prior such violations, the degree of culpability and any other considerations as justice may require.


[1] 42 U.S.C. 282(j)

[2] Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions

[3] 21 U.S.C. 333(f)(3)

[4] Goldacre et al., 2018. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

[5] Anderson et al., 2015. Compliance with Results Reporting at ClinicalTrials.gov

[6] FDA Compliance Program Guidance Manual 7348.810 Sponsors, Contract Research Organizations and Monitors

[7] 42 U.S.C. 282(j)(5)(C)(ii)

[8] 21 U.S.C. 333(f)(6)

[9] 21 U.S.C. 333(f)(3)(A)

[10] 21 U.S.C. 333(f)(3)(B)

[11] 21 U.S.C. 333(f)(5)(B)