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2011 Wis. L. Rev. 929 (2011)
Patients over Politics: Addressing Legislative Failure in the Regulation of Medical Products

handle is hein.journals/wlr2011 and id is 939 raw text is: PATIENTS OVER POLITICS: ADDRESSING LEGISLATIVE FAILURE IN THE REGULATION OF MEDICAL PRODUCTS EFTHIMIoS PARASIDIS* This Article proposes reform measures that mitigate risk-enhancing aspects of the regulatory framework for medical products. By incentivizing product analysis and information disclosure, the proposals aim to ensure that marketed products contain accurate risk-benefit profiles. Under the proposed reforms, firms must conduct active post-market analysis for the entire lifecycle of their products and disclose research findings to the FDA and public. The mandatory post-market analysis and disclosure requirements are aligned with preemption laws, such that firms may benefit from limited liability only if they have successfully completed their post- market obligations. The underlying goal of the proposed framework is to advocate a cost-effective theory of regulation that promotes legitimacy, accuracy, and transparency by incorporating innovations that account for regulatory failure and asymmetries in information into regulatory procedure. In the context of health care markets, this process of innovative regulating informs health-related decisions, reduces patient risk and health care costs, and improves the quality of health care. Introduction .................................. .......930 I. From Passive Surveillance to Active Analysis of Post Market Risks............................. 936 A. Evolution of Statutory Authority for Post-Market Review.....................................937 B. Recent Post-Market Surveillance Initiatives ..... .....950 II. The Role of Preemption Laws in the Regulation of Medical Products .......................... ............953 * Assistant Professor of Law, Center for Health Law Studies, Saint Louis University School of Law; member of the Law & Policy Workgroup of Missouri Health Connection, the entity responsible for creating Missouri's health information exchange. I thank Alta Charo, Monica Eppinger, Chad Flanders, Roger Goldman, Joel Goldstein, Tim Greaney, Sam Halabi, William Janssen, Sandra Johnson, Kevin Outterson, Frank Pasquale, Jeff Redding, Magdalen Sarrinikolaou, Molly Walker- Wilson, and Sidney Watson for insightful comments. I presented earlier versions of this Article at the 34th Annual Health Law Professors Conference (held at Loyola-Chicago School of Law), the 2011 SEALS Junior Scholar Workshop, and faculty workshops at Washington University School of Law, Saint Louis University School of Law, and the Mailman School of Public Health at Columbia University, and thank participants at these presentations for helpful discussions. Kathleen Casey, Chad Finley, Zachary Wood, Jonathan Pollman, and Ritesh Agrawal provided excellent research assistance. Saint Louis University awarded a generous grant to support this project. A special thanks to Zachary Pfeiffer and the editors of the Wisconsin Law Review for outstanding editorial assistance.

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