In February the Department of Human Health & Services and the FDA lost a lawsuit regarding missing clinical trial data in the ClinicalTrials.gov repository, which I wrote about here. Prior to the judges’ decision, despite the transparency requirements, FDA has never imposed a fine on a clinical trial’s sponsor, and the National Institutes of Health has never publicly named non-compliant sponsors or withheld grant funding.
Compelled to take enforcement action, the FDA has now published a guidance called Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.
Those sponsors who are directly affected would do well to read the full guidance, which I linked to above. For everyone else, I will try to summarize with as little legalese as possible.
The guidance says that the FDA Centers “intend to focus their enforcement and regulatory attention in the following areas:”
- Responsible parties who have failed to submit required clinical trial registration and/or results information (…) for applicable clinical tr ials of products that potentially may pose a higher risk to human subjects or applicable clinical trials of products intended to address significant public health need.
- Responsible parties or submitters who have had a pattern of previous noncompliance with the requirements to submit clinical trial information and/or certifications.
- Applicable clinical trials for which noncompliance with the requirements (…) exists in conjunction with noncompliance with other statutory and/or regulatory requirements pertaining to the conduct of the trial, for example the failure to retain clinical trial records or the failure to obtain informed consent.
Nothing unusual there, the FDA takes a risk based approach as it so often does.
After the FDA determines a responsible party is not in compliance, it will issue a Pre-Notice Letter. The responsible party has 30 calendar days to come into compliance. After 30 days the FDA “intends to review the information submitted to the ClinicalTrials.gov data bank for that applicable clinical trial, the application/submission in FDA files, and/or any other information available to the Agency, to determine whether a violation exists. If the Center determines that a responsible party failed to submit any required clinical trial information to the ClinicalTrials.gov data bank and/or submitted information that is false or misleading in any particular, the Agency will issue the responsible party a Notice of Noncompliance.” Such a Notice of Noncompliance will be published publicly and be made available to the NIH. After that, the responsible party has another 30 calendar days to come into compliance.
With regards to civil money penalties, it states that “FDA intends to take into consideration any corrective action taken by a responsible party or submitter after receiving a Notice of Noncompliance. If a responsible party or submitter does not remedy noncompliance within 30 calendar days after receiving a Notice of Noncompliance, the Center generally intends to seek civil money penalties, taking into account the type of noncompliance and the circumstances associated with the lack of remediation.”
With regards to procedure, it is stated that “Civil money penalty actions are initiated when the Center with principal jurisdiction over the matter involved files a Complaint with FDA’s Division of Dockets Management and serves the Complaint on the respondent (in this case, the responsible party or submitter).” And “Upon being served, the responde nt generally responds by: (1) either paying the penalty sought in the Complaint; or ( 2) filing a n Answer with the Division of Dockets Management and contesting some or all of the Center’s allegations.” An Answer to the Complaint would have to be filed within 30 calendar days of the date of service of the Complaint. If the responsible party does so, they will be entitled to a hearing (as per 21 CFR Part 17). If a settlement is not reached the case will be decided by a presiding officer. After an initial decision has been made by the presiding officer, either party can appeal to the HHS Dapartmental Appeals Board.
“The statutory maximum penalties (…) 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, (…) 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.”
Lastly, it is stated that “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.”
If you see any errors or serious omissions in the above, or you have a topic which you think I should cover on this blog, please let me know by emailing to [eeb_mailto]info@itenmeer.nl