Patients Over Politics: Addressing Legislative Failure in the Regulation of Medical Products
74 Pages Posted: 25 Nov 2011 Last revised: 28 Jul 2013
Date Written: November 1, 2011
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: Suggested Citation