The FDA released a new draft Drug Safety Guidance for Industry on December 16, 2015. The draft document recommends the use of special Safety Assessment Committees to oversee and report on patient safety data throughout a drug’s development program. The intended impact is to improve patient safety through a more structured safety assessment and reporting system for all investigational new drugs (IND).
The draft guidance is titled, “Safety Assessment for IND Safety Reporting, Guidance for Industry”, and is available at the FDA’s “Newly Added Documents” repository. The guidance outlines the structure and practices of the new Safety Assessment Committee (SAC) role within all drug development programs and multi-study programs in particular.
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 and a safety surveillance plan as “key elements of a systematic approach to safety surveillance.”
Recommended Safety Assessment Committee (SAC) Composition
- At least one physician familiar with the therapeutic area of the investigational drug
- Clinicians with general or specific safety experience (e.g., cardiology, neurology)
- Qualified by safety assessment training and experience
- Available to review safety information on a regular or ad hoc basis
- Comprised of fully independent, external members, sponsor members, or a hybrid, as needed
Differences between a Safety Assessment Committee (SAC) and a Data Monitoring Committee (DMC)
The FDA guidance clarifies that this new SAC is “distinct from a DMC”, although a DMC’s expertise and reports can be used to facilitate operations of the SAC. Separate processes will need to be created to modify DMC data for the SAC’s use. This includes ensuring limitations on the SAC’s exposure to unblinded data and the exclusion of efficacy data.
Need help understanding and meeting the new requirements?
ACI Clinical’s safety and committee experts can help you navigate these new safety reporting requirements and develop a Safety Assessment Committee solution tailored to your unique drug development needs.
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