Spending on postapproval drug safety.
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Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was 56 million dollars (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that total spending on postapproval safety by the top twenty drug manufacturers was 800 million dollars in 2003. We also examined, using regression analysis, the relationship between the number of safety personnel and the number of initial adverse-event reports. This study offers information for the debate on proposed changes to safety surveillance.
SubjectCosts and Cost Analysis
Product Surveillance, Postmarketing
Published Version (Please cite this version)10.1377/hlthaff.25.2.429
Publication InfoGrabowski, Henry G; Kramer, JM; Ridley, David Blaine; Schulman, Kevin Alan; & Tilson, HH (2006). Spending on postapproval drug safety. Health Aff (Millwood), 25(2). pp. 429-436. 10.1377/hlthaff.25.2.429. Retrieved from http://hdl.handle.net/10161/6397.
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Professor Emeritus of Economics
Professor Grabowski specializes in the investigation of economics in the pharmaceutical industry, government regulation of business, and the economics of innovation. His specific interests within these fields include intellectual property and generic competition issues, the effects of government policy actions, and the costs and returns to pharmaceutical R&D. He has been publishing research papers for over four decades, from his earlier work, “The Effects of Regulatory Policy on the Incentives
Professor of the Practice of Business Adminstration
David Ridley is the Dr. and Mrs. Frank A. Riddick Professor of the Practice of Business Administration. He is also the Faculty Director of Duke's Health Sector Management program. In his research, David examines innovation and pricing, especially in health care. He was the lead author of the paper proposing the priority review voucher program to encourage development of drugs for neglected diseases.
Adjunct Professor in the Department of Medicine
Kevin A. Schulman, MD, MBA, is a professor of medicine and the Gregory Mario and Jeremy Mario Professor of Business Administration (2010 - 2016) at Duke University. He is a visiting professor of business administration at Harvard Business School. He holds several leadership appointments at Duke. He is an associate director of the Duke Clinical Research Institute in the School of Medicine, the country's largest academic clinical research organization. In Duke's Fuqua School of Business, he s
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