John Gray Abstract

Title: The Relative Effectiveness of Announced and Unannounced Inspections

The FDA is responsible for ensuring the quality of pharmaceuticals sold in the United States. For decades, the FDA has utilized facility inspections to ensure compliance with manufacturing quality regulations. Such inspections in the United States are almost always unannounced, while those performed in foreign countries are announced up to three months in advance. A comparison of inspection effectiveness between these two inspection regimes has not been rigorously empirically evaluated. This study addresses this by examining FDA inspections in the United State and India, exploiting two unannounced-inspection pilots performed in India. Using a panel matching approach to mimic the FDA’s inspection Site Selection Model, we examine both inspection outcomes and post-inspection serious adverse events. We find that there is no difference between the likelihood of the most extreme inspection outcomes occurring when comparing all inspections in India, the vast majority of which are pre-announced, to those in the United States, which has only unannounced inspections. However, when comparing unannounced inspections from the pilots in India to comparable inspections in the United States, we find that the India inspections are multiple times more likely to receive the most extreme inspection outcomes. Further, we find evidence of a decrease in serious adverse events following extreme inspection outcomes in India, pointing to the importance of accurate assessments of foreign drug facilities in inspections. Our findings highlight the importance of using unannounced inspections.

Co-authors:

Zach Wright, OSU (lead

John Gray, OSU

In Joon Noh, Penn State

George Ball, Indiana

John Gray Background

John Gray is a Dean’s Distinguished Professor of operations and business analytics. He joined Fisher after receiving his PhD from the Kenan-Flagler Business School at the University of North Carolina-Chapel Hill. Prior to pursuing his PhD, he worked for eight years in operations management at Procter & Gamble, receiving an MBA from Wake Forest University’s evening program during that time. He holds two undergraduate degrees from Dartmouth College and its Thayer School of Engineering.

Dr. Gray teaches/has taught an elective he created called Strategic Global Sourcing (at the Ph.D., Executive, MBA, and undergraduate levels) and Data Analysis (at the Ph.D., Executive, and MBA levels); he has won a college teaching award for each class. A student project from his elective led to a co-authored case (Scotts Miracle-Gro: The Spreader Sourcing Decision) that has been widely adopted, earning the title of an “Ivey Classic”. He serves as academic co-director of the new Master of Supply Chain Management program at Fisher and also serves as academic director the college’s Ph.D. programs.

Dr. Gray’s research has been published in top multi-disciplinary management journals, including Decision Sciences, Management Science and Organization Science; and top operations and supply chain journals, including the Journal of Operations Management, the Journal of Supply Chain Management, and Production and Operations Management. His research has received several awards, the Jack Meredith Best Paper award from the Journal of Operations Management and the Emerald Citations of Excellence award which recognizes the most impactful articles across a wide range of journals. Two of his papers were awarded the OM Division's Chan Hahn best paper award at the Academy of Management conference. Within Fisher, he was named to the inaugural class of Dean’s Faculty Fellows, a distinction he held from 2014-2017.

He has also received substantial external funding, including being co-PI of a $1.7 million two-year contract with the FDA awarded from October 2019-September 2021. He has also served as a Department Editor at the Journal of Operations Management and a Senior Editor at the Production and Operations Management journal. He is Vice President and President-Elect of the Industry Studies Association; for which we served as conference chair for its 2023 conference in Columbus.

In August 2022, he began a part-time role as a consultant for the Office of Science and Technology Policy in the Executive Office of the President (EOP) of the United States. He is a member of the Pandemic Preparedness Team, advising them and others in the EOP on issues related to pharmaceutical supply chains.

Molly Hughes Abstract

Title: Public policy and supply chain risk management: literature review, conceptual model, and future research agenda

In the supply chain management (SCM) literature, public policy plays a wide variety of roles including a source of disruption, risk mitigation, and the result of SCM choices. The emphasis on aspects of supply chain risk management leads us to ask: What is the nature of the interrelationship between public policy and supply chain risk management (SCRM)? To our knowledge, a review of this overlap has yet to be conducted despite an increasing trend in articles published covering this cross-section (public policy and SCRM) and a call from supply chain scholars for a deeper understanding of how supply chain management and public policy interplay. Through the review of SCM and public policy journals, a conceptual model representing the overlap between SCRM and public policy is developed, depicting the elements and relationships between those elements. Additionally, under-explored aspects of these elements and the relationships therein are identified for future research.

Co-authors:

Keely Croxton, OSU

A. Michael Knemeyer, OSU

Molly Hughes Background

Molly Hughes received her B.S. in Business Administration, specialized in Logistics and Marketing, from The Ohio State University in Columbus, Ohio followed by a year studying towards a M.Sc. in Logistics at Kuehne Logistics University in Hamburg, Germany. This lead to an intern position on the Capital Projects team at Cardinal Health (a Fortune 20 company) where she managed business continuity projects and a vault installation. This lead to full-time employment on the Quality and Regulatory Affairs team followed by a promotion and switch to the Branded Drug Strategic Sourcing team where she worked as an Advisor then Manager, controlling over $17 billion in annual spend. She then accepted a Sr. Manager position at the largest generic drug sourcing company in the U.S., Red Oak Sourcing, and moved to Foxboro, Massachusetts.

The work in this highly regulated industry lead her back to The Ohio State University to pursue a Ph.D. (and M.A. along the way) in Logistics and Supply Chain Management, focusing on how public policy and supply chain risk management interact in the U.S. pharmaceutical supply chain. While in this program she worked with 12 other scholars from R1 institutions on $1.7 million, grant-like project for the Food and Drug Administration. This research focused on quality management and pharmaceutical firm learning to reduce drug quality risks.

Her research follows three streams: supply chain risk, public policy and SCM, and the pharmaceutical supply chain. Her research is motivated by her time in industry and the potential impact to society. Because of this focus and background her research tends to be empirical in nature.