Patients Over Politics: Addressing Legislative Failure in the Regulation of Medical Products

74 Pages Posted: 25 Nov 2011 Last revised: 28 Jul 2013

See all articles by Efthimios Parasidis

Efthimios Parasidis

Ohio State University (OSU) - Michael E. Moritz College of Law

Date Written: November 1, 2011

Abstract

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.

Keywords: FDA, post-market surveillance, preemption, tort law

JEL Classification: I18, K13, K23, L15, L51

Suggested Citation

Parasidis, Efthimios, Patients Over Politics: Addressing Legislative Failure in the Regulation of Medical Products (November 1, 2011). Wisconsin Law Review, Vol. 2011, No. 5, Available at SSRN: https://ssrn.com/abstract=1964025

Efthimios Parasidis (Contact Author)

Ohio State University (OSU) - Michael E. Moritz College of Law ( email )

55 West 12th Avenue
Columbus, OH 43210
United States

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