The FDA Modernization Act of 1997 (FDAMA) that established Clinicaltrials.gov requires that sponsors register their trials and update information regarding them as appropriate over time. Yet, in the more than 20 years that the site has been live, compliance has been an ongoing challenge. Research by Bracken Data, a sister company to the Bracken Group, has shown that the rate of compliance is 70.6% for studies that are recruiting and only 35.4% for all studies.
The 21st Century Cures Act, signed into law in December 2016, includes possible penalties of as much as $500,000 for organizations operating trials that are not in compliance. A draft guidance released by the FDA in September 2018 suggests a one-time penalty of as much as $10,000 for any violation “adjudicated in a single proceeding.” If a violation is not corrected within 30 days following the sponsor’s notification, penalties can accrue at a rate of $10,000 per day for each violation until corrected. Yet, it appears that if any penalties have been levied, they have been few.
Now the FDA has moved again to address non-compliance. A guidance regarding civil money penalties the FDA may levy for clinical trial reporting violations, “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” was released in August.
If you missed the RFI, but still want to weigh in on how ClinicalTrials.gov might be improved, don’t fret. The NLM states that it is always open to suggestions and comments via email at email@example.com.
This latest guidance details how Centers within the FDA plan to determine if responsible parties have failed to submit required clinical trial registration or results to the ClinicalTrials.gov data bank, or if parties have falsified data or filed misleading information, or failed to submit the certification to FDA. Evidence uncovered during the FDA’s Bioresearch Monitoring Program (BIMO) will generally serve as the basis for identifying violators.
The guidance lays out the circumstances under which Centers at FDA may begin notification steps that may ultimately lead to civil money penalties:
When a party responsible for a clinical trial may have failed to comply with clinical trial registration and results submission requirements, or have violated the certification requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the Center’s first step will generally be to send a Pre-Notice letter. This letter gives the responding party 30 days to address the violation.
The appropriate Center will review responses to the Pre-Notice letter and other available information from the clinical trials databank and FDA application or submission files. If violations are found after this investigation, the responsible party will receive a Notice of Noncompliance, starting another 30-day clock for the recipient. These notices will be posted on the FDA website.
The determination to seek civil money penalties will hinge in part on whether the responsible party has taken corrective action prior to the 30-day mark after receiving the Notice of Noncompliance. If action has not been taken, “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.”
The statutory amounts for penalties remain the same as those described in the draft guidance of 2018: $10,000 for all violations adjudicated in a single proceeding and not more than $10,000 for each day after notification that a violation continued uncorrected.
Among the factors, the agency will consider in setting the amount of a penalty are “the nature, circumstances, extent, and gravity of the violation(s) and, with respect to the violator, ability to pay, effect on the ability to continue to do business, any history of prior such violations, the degree of culpability and such other matters as justice may require.”
We at The Bracken Group urge sponsors to not underestimate the complexity of registering and staying in compliance with ClinicalTrials.com. Talk with us if you’d like some help with the process.