The McDonough School of Business will work on a project with Washington University in St. Louis and the U.S. Food and Drug Administration to help modernize the FDA’s drug manufacturing performance, a university press release announced last week.
Assistant business professor Jeffrey Macher and associate professor Jackson Nickerson of the Olin School of Business at Washington University will lead the research for the study.
The FDA announced the initiative in a Sept. 3 report on the anniversary of its Good Manufacturing Practices Initiative for the 21st Century, a major program launched last year by the administration.
In an effort to upgrade the FDA’s regulation of pharmaceuticals, Macher and Nickerson will help identify the factors that predict manufacturing performance.The study will examine the model the FDA uses for inspection, and thus, will help the FDA understand whether firms have good understanding of current good manufacturing practices, or cGMP. The FDA will then be able to target certain firms that are at risk of violating cGMP. In addition, they will identify the risks related to pharmaceutical quality and evaluate the FDA’s compliance program. Macher and Nickerson became interested in the practices of the FDA after witnessing an increase in the number of fines issued, as well as the amount of the fines issued, by the FDA. In a meeting with members of the FDA, they explained their intentions of helping regulate firms to maintain a high quality environment, and thus began their studies.
Macher and Nickerson will announce the results of their study within the next year.
“This collaboration underscores the positive impact of academic inquiry brought to bear on industrial and regulatory practices,” MSB Dean John W. Mayo said.
The funding for the research will be provided by the MSB’s Center for Business and Public Policy; the Boeing Center for Technology, Information and Manufacturing; the Center for Research in Economics and Strategy in the Olin School of Business at Washington University in St. Louis and the Sloan Foundation at the National Bureau of Economic Research.
Additionally, Macher and Nickerson are collaborating on a second study which will assist the actual pharmaceutical manufacturers. They will “identify technical, managerial and organizational practices which lead to better performance,” Macher said. In doing so, they will help the firms stay in line with FDA requirements by improving overall production efficiencies.
Macher is a fellow in the MSB’s Center for Business and Public Policy and also teaches courses in microeconomics, strategy and the management of technology and innovation.
