The Government Accountability Office (GAO) is the arm of the Congress that performs audits and studies of FDA processes and policies and makes recommendations for improvement. Most studies are specifically requested by Congress, either mandated in legislation or requested by letter. The Office of the Inspector General (OIG) performs audits of HHS programs, including FDA, and makes recommendations for improvement. Organizationally, it is an arm of HHS, but operates independently.
The GAO/OIG Liaison Team leads and manages all aspects of GAO and OIG studies/audits that involve FDA. The Team ensures that GAO and OIG engage with the appropriate Agency experts and receive accurate and timely information in response to their requests. It provides study teams with strategic advice on how to articulate Agency’s message in response to GAO and OIG reports most effectively.
Managing the studies includes ensuring that FDA responses to requests for information are appropriate, cleared by Agency officials, and on-time; identifying and resolving sensitive matters and facilitating leadership involvement as necessary; and ensuring that the tone of FDA engagement is positive and productive. In addition, the GAO/OIG Liaison Team manages FDA’s regular updates on Agency implementation of GAO/OIG recommendations.
Due to the broad-ranging topics the GAO and OIG have reviewed over time, the Team has broad knowledge of FDA programs and of the auditors’ protocols and policies, as well as expertise in workgroup management, conflict resolution, and consensus development.