In December 2015, the FDA released a new draft Guidance for Industry related to IND Safety Reporting. The guidance states that due to the critical need to detect and report serious adverse events as early as possible, the FDA recommends that sponsors form a Safety Assessment Committee to use along with a safety surveillance plan as “key elements of a systematic approach to safety surveillance.”
This guidance serves as yet another follow-on to several earlier regulatory instructions on this topic, including the September 2010 Final Rule for Reporting Requirements and the December 2012 Safety Reporting Guidance to help sponsors comply with the Final Rule. For those who are less familiar with types of FDA regulations, a Final Rule is equivalent to a law that everyone must follow, whereas a Guidance represents current FDA thinking but is not binding. The FDA has been clear that uninformative expedited safety reports are distractive and unwanted as they require extensive FDA resources and they make it difficult to find and focus on the important safety risks that should be receiving the attention.
In January 2016, several FDA employees authored a publication in the American Association for Cancer Research that shared how the FDA’s Office of Hematology and Oncology Products received an average of 17,686 expedited safety reports per year between 2006 and 2014. An FDA audit of 160 of those expedited safety reports revealed only 22 informative reports, signifying that the “submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals.” As a result of this ongoing challenge, the latest draft guidance recommends implementation of a Safety Assessment Committee on every drug program under an IND so that a distinct group can be given the responsibility to review unblinded safety cases and make a determination about whether or not they meet the criteria for expedited safety reporting. The document outlines the recommended structure and practices for implementation of a Safety Assessment Committee.
Unfortunately, there is not a “one-size-fits-all” solution. Depending on a company’s size, internal resources, types of development programs and sophistication level of safety surveillance processes, there are many approaches that could be adapted to best fit a company’s process without introducing a significant new cost burden. As an expert in independent committee management for clinical studies, ACI Clinical can help companies navigate these new safety reporting requirements and develop a Safety Assessment Committee solution tailored to your unique drug development needs.
To review the full FDA draft guidance, please visit: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm477584.pdf