FDA awards $1.7 million to IU and other universities for quality management research

BLOOMINGTON, Ind. — The U.S. Food and Drug Administration has awarded $1.7 million to five universities, including Indiana University, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.

IU is administering the federal contract. Principle investigators are George Ball, assistant professor of operations and decision technologies and Weimer Faculty Fellow at the IU Kelley School of Business; and John Gray, professor of operations at the Fisher College of Business at Ohio State University.

Faculty from the University of Illinois, University of Wisconsin and Long Island University are also engaged in the two-year research project. Total value of the contract is $1,744,985.

“Our objective will be to examine which FDA quality management activities are most effective, given a set of conditions, at stimulating firm attention to quality risk such that learning and subsequent product quality improvement occurs,” Ball said. “In other words, we intend to help the FDA understand not just what should be done to improve drug quality but how, and under what conditions, it should be done.

“These insights will help the FDA more effectively and efficiently ensure the safety, quality and efficacy of the global supply of drugs consumed by all Americans,” added Ball, who spent 11 years in various managerial and director roles at two major medical device companies before entering academia.

Adverse drug events cause nearly 1 million emergency room visits each year, while serious drug product recalls have increased each year over the past decade.

For many years, the FDA has worked with manufacturers to motivate them to consistently comply with current good manufacturing practices to ensure consistent quality in the drugs produced, said Gray, whose research focus is on pharmaceutical quality.

“What’s not necessarily clear are the conditions under which each of these significant efforts are more or less effective at encouraging pharmaceutical firms to focus attention on quality and compliance, and whether and when such focus is fleeting or sustained,” he said.

There are two aspects to the project. Initial efforts will be directed toward developing a statistical model that will provide insights into the effectiveness of FDA efforts. Researchers will draw upon data from public sources as well as FDA-provided information to predict which inspection activities lead to higher drug product quality.

Given the challenges of inferring cause with observational studies, the second project will be composed of behavioral experiments to develop a better understanding of the trade-offs between collaborative or adversarial approaches, and the conditions under which such approaches are more effective.

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Others involved in the project include:

  • Enno Siemsen, associate dean of MBA and master’s programs and the executive director of the Erdman Center for Operations and Technology Management, and Hessam Bavafa, assistant professor of operations and information, both at the Wisconsin School of Business at the University of Wisconsin-Madison.
  • Gopesh Anand, associate professor of business administration and academic director of operations management at the Gies College of Business at the University of Illinois Urbana-Champaign.
  • Hyunwoo Park and Christian Blanco, assistant professors of management science at the Fisher College of Business at Ohio State University.
  • Kenneth R. Morris, University Professor and director of the Lachman Institute for Pharmaceutical Analysis at Long Island University.

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