Penalty policy for trial reporting violations finalized
The US Food and Drug Administration has finalized guidance for civil money penalties it may levy for clinical trial data bank reporting violations.The final document follows a September 2018 draft that addressed the question of how FDA’s Centers should deal with responsible parties who breach federal regulations requiring accurate and complete registration of clinical trials and reporting of results on the www.clinicaltrials.gov website.
This final guidance details how centers within FDA plan to identify 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 certification to FDA. Generally, evidence kicked up during the FDA’s Bioresearch Monitoring Program (BIMO) will serve as the basis for identifying violators, according to the guidance, though action may also be complaint-driven.
The guidance lays out the circumstances under which Centers at FDA may begin notification steps – which may ultimately lead to civil money penalties -- for those responsible for the conduct and reporting of clinical trials.
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, says FDA in the guidance, will hinge in part on whether the responsible party has taken corrective action within 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 guidance also details the procedures FDA will follow regarding civil monetary penalty proceedings, which are governed by 21 CFR 17.
Under section 2020(F)(3)(A) of the Food, Drug, and Cosmetic Act, the statutory amounts for penalties are not more than $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, it says, are “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.”
FDA