Violators of Clinicaltrials.gov Requirements Given a Break by FDA
[Thursday, August 20, 2020]
After years of hesitating to enforce the clinical trial reporting requirements, this week FDA released its guidance on penalties for non-compliance with clinicaltrials.gov posting rule. It satisfies the critics of the non-enforcement but at the same time gives a huge break to the current violators by wiping the slate clean and restarting the clock, in a way. The new guidance comes almost 4 years to the date NIH and FDA announced final rules for mandatory reporting of clinical trial results on clinicaltrials.gov. And it comes after repeated pleas by multiple public groups to enforce clinicaltrials.gov posting rules and reports of repeat offenders. They key element of the clinicaltrials.gov rules has been hefty civil monetary penalties for non-compliance; public groups have calculated that the government could have collected tens of billions of dollars in fines from violators. The guidance lists the specific violations and the conditions under which monetary penalties will be imposed but does not discuss past violations. The process will follow three steps. First, FDA would send a “Pre-Notice” to violators it found either during an audit of the sponsors of clinical trials or in response to complaints received from public. The Pre-Notice will give the violators 30 days to address the violation. During the 30-day warning period, the violators are expected to rectify the clinicaltrials.gov reporting errors and demonstrate reasonable efforts to address the violations. If, at the end of the 30-day “Pre-Notice” period, the violations are still not addressed, FDA will issue the “Notice of Non-compliance”, and give another 30 days to comply. Finally, if the violations have still not been addressed, FDA would seek civil monetary penalties taking into account the type of non-compliance and the circumstances associated with the lack of remediation. The FDA seems to take a compassionate approach to imposing penalties, giving the violators multiple chances to address the violations or justify the reasons for non-compliance, dispute the violations, and file petitions for lowering the penalty amounts. For the amount of monetary penalty, FDA will consider several factors such as “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.” The guidance seems to present a balanced approach to correct a violation that has been happening since the beginning of the clinicaltrials.gov registry. This guidance is a highly anticipated first document from FDA to address a well-known and documented non-compliance with the clinical trials transparency requirements. It is the one “get out of jail card” to violators of clinicaltrials.gov reportees. Hopefully, it will help address the public grievance while avoiding anxiety among the sponsors.