The U.S. Food and Drug Administration (FDA) will collaborate in part with Jackson A. Nickerson, Ph.D., associate professor of organization and strategy in the Olin School of Business, as part of its strategic initiative to modernize the regulation of pharmaceutical manufacturing and product quality.
Also working with the FDA will be Jeffrey T. Macher, Ph.D., assistant professor at the Robert Emmett McDonough School of Business at Georgetown University.
The FDA announced the collaboration in a recent report on the first anniversary of its “Good Manufacturing Practices Initiative for the 21st Century.”
Under the terms of the material transfer agreement, Nickerson and Macher will conduct research to help the FDA identify the factors that predict manufacturing performance to further refine the agency’s risk-based site selection model for inspections and its other efforts. The goal is to identify risks to pharmaceutical quality and strengthen the FDA’s pharmaceutical compliance program.
Nickerson noted that the number of penalties issued against pharmaceutical firms over manufacturing concerns is dramatically increasing. According to the FDA, it issued roughly 1,180 warning letters in 2000 to health-care facilities, drug makers, food companies and cosmetics firms — a 31 percent increase from around 900 each of the previous two years.
Also increasing in number are pharmaceutical companies suffering delays in launching new drugs or experiencing product shortages because of failure to comply with FDA requirements.
“The public policy impact of failures to meet the FDA’s current good manufacturing practices goes far beyond whether or not manufacturers pay fines,” Nickerson said. “Products that can not only improve the health of Americans but also potentially reduce health-care costs are not reaching patients in a timely fashion or are not available.
“FDA penalties and delays, while appropriate and legitimate, substantially increase manufacturing costs and impact public welfare. Our project seeks to study the sources of manufacturing difficulties and make recommendations to both the FDA and industry on how to moderate and eliminate those problems.”
Stuart I. Greenbaum, Ph.D., dean of the Olin School of Business and the Bank of America Professor of Managerial Leadership, said the collaborative study is a milestone toward rationalizing the manufacture of pharmaceuticals for the benefit of mankind.
“McDonough and Olin are joining forces to develop practices and processes that will reduce the costs and expand the availability of life-saving medicines,” Greenbaum said.
Funding for Nickerson and Macher’s research comes from the Boeing Center for Technology, Information and Manufacturing and the Center for Research in Economics and Strategy in the Olin School of Business, as well as the National Bureau of Economic Research and the Alfred P. Sloan Foundation.
Nickerson teaches undergraduate, graduate and doctoral courses in management, strategic management in health care, strategic management in life sciences and competitive strategy at the Olin School. His research focuses on business strategy and public policy, organizational economics, new institutional economics, intellectual capital management, technology licensing and organizational theory.
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