The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it.

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.

Over the past year, Mary and her team at the GAO have published two FDA-specific reports:

Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight: https://www.gao.gov/products/gao-20-594
Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog: https://www.gao.gov/products/gao-21-409t

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Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health Care

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