The Effects of Product Liability Exemption in the Presence of the FDA

In the United States, drugs are jointly regulated by the US Food and Drug Administration, which oversees premarket clinical trials designed to ensure drug safety and efficacy, and the liability system, which allows patients to sue manufacturers for unsafe drugs. In this paper, we examine the potential welfare effects of this dual system to ensure the safety of medical products, and conclude that product liability exemptions for FDA regulated activities could raise economic efficiency. When the safety level mandated by the FDA is binding--in the sense that manufacturers will not conduct additional clinical testing beyond what is mandated by FDA--then product liability may reduce efficiency by raising prices without pushing firms, who are already bound by the FDA's requirements, to invest further in product safety. We consider as a case study the National Vaccine Injury Compensation Program, which sharply reduced vaccine manufacturer's liability in 1988. We find evidence that the program reduced prices without affecting vaccine safety, suggest that liability limits can enhance economic efficiency in the presence of the FDA.

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Tomas J. Philipson is a visiting scholar at AEI. Dana Goldman is in the School Policy, Planning and Development at the University of Southern California. Eric C. Sun is at the University of Chicago.

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About the Author

 

Tomas J.
Philipson
  • Tomas J. Philipson is a visiting scholar at AEI and the Daniel Levin Chair in the Irving B. Harris Graduate School of Public Policy as well as an associate member of the department of economics at the University of Chicago. He was a senior health care adviser to the 2008 presidential campaign of John McCain and served in the Bush administration as the senior economic adviser to the commissioner of the Food and Drug Administration from 2003 to 2004 and subsequently as the senior economic adviser to the administrator of the Centers for Medicare & Medicaid Services from 2004 to 2005. Mr. Philipson is an editor of Forum for Health Economics & Policy and is on the editorial board of Health Economics and The European Journal of Health Economics. He has twice been the recipient of the highest honor of his field, the Kenneth Arrow Award from the International Health Economics Association, in 2000 and 2006.  Mr. Philipson is the cofounder of Precision Health Economics, is an adviser to the Gerson Lehrman Group, and is a consultant for Compass-Lexecon and Analysis Group.
  • Email: t-philipson@uchicago.edu

 

Dana
Goldman
  • Dana Goldman is a Professor and the Norman Topping Chair in Medicine and Public Policy at the University of Southern California. Until Fall 2009, he held RAND's Distinguished Chair in Health Economics and directed RAND's program in Economics, Finance, and Organization. He is also an Adjunct Professor of Health Services and Radiology at UCLA.


    Dr. Goldman is a nationally-recognized health economist influential in both academic and policy circles. He is the author of over 100 articles and book chapters, including articles in some of the most prestigious medical, economic, health policy, and statistics journals. He is a health policy advisor to the Congressional Budget Office, and is a frequent speaker on health care issues. He serves on several editorial boards including Health Affairs and the American Journal of Managed Care. He is also a founding editor of the Forum for Health Economics and Policy, an online journal devoted to health economics and health policy.

  • Email: dpgoldma@usc.edu

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