SOPP 8420: FDAAA Section 921: Posting of Potential Signals of Serious Risk

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Effective Date: November 1, 2011

Purpose

This SOPP describes the policy and procedures for Center for Biologics Evaluation and Research (CBER) staff in developing and posting quarterly lists of potential signals of serious risks identified by the Adverse Event Reporting System (AERS) in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA), Title IX, Section 921.
Scope

This SOPP applies to all marketed drugs and therapeutic biologics regulated by CBER and included in Section 921 of FDAAA. Vaccines are exempt as noted below.

Please refer to MAPP 6700.9: FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System for information on products regulated by the Center for Drug Evaluation and Research (CDER).
Background
1. Title IX, Section 921 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs FDA to conduct bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by AERS within the last quarter.
2. FDA also communicates product risks to the public using other methods, such as FDA Safety Notifications (see references), Public Health Advisories, and product labeling. As FDA completes its evaluation of each potential safety issue, one or more of these methods as well as additional public communications may be issued as appropriate.
Definitions
1. Adverse Event Reporting System (AERS) – AERS is a computerized information database designed to support the FDA’s postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.
2. Potential Signal of a Serious Risk - New safety information as defined in FDAAA [section 505-1(b)(3)] includes, among other things, information derived from Adverse Event (AE) reports about a serious risk associated with use of a drug that FDA has become aware of since the drug was approved or, for drugs that have Risk Evaluation and Mitigation Strategies (REMS), since the REMS was required or last assessed. “Potential” signals are typically at the earliest stages of identification, where it is known that the issue needs to be evaluated further, but it is not known if a regulatory action will be needed. Drug refers to drug and therapeutic biologic products regulated by the FDA.