Spending on postapproval drug safety.
Date
2006-03
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
Attention Stats
Abstract
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.
Type
Department
Description
Provenance
Citation
Permalink
Published Version (Please cite this version)
Publication Info
Ridley, David, Judith Kramer, Hugh Tilson and Kevin Schulman (2006). Spending on postapproval drug safety. Health Aff (Millwood), 25(2). pp. 429–436. 10.1377/hlthaff.25.2.429 Retrieved from https://hdl.handle.net/10161/6397.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
Scholars@Duke
David Blaine Ridley
David Ridley, PhD, is a health economist and Dr. and Mrs. Frank A. Riddick, Jr. Research Fellow at Duke University's Fuqua School of Business. His research focuses on incentives for innovation and quality, as well as pricing. He is dedicated to creating and studying tools that improve health.
David was the lead author of two papers that became law. He and his colleagues proposed the Food and Drug Administration (FDA) priority review voucher program which became law in 2007. The vouchers provide incentives for drug development for neglected and rare diseases. The FDA has awarded more than 70 vouchers valued at about $100 million each. David and his colleagues also proposed the Environmental Protection Agency vector expedited review voucher program which became law in 2022.
David has served for more than a decade as the Faculty Director for the Center for Health Sector Management (HSM). HSM students comprise nearly 20 percent of Duke MBA graduates each year. David received a doctorate in economics from Duke University.
Judith Mae Kramer
· Studying methods to facilitate the uptake of evidence-based treatment recommendations.
· Optimizing the use of drugs, devices, and biological products in clinical practice.
· Studying methods of risk management for therapeutic products
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.